| Coverage Policy Manual | |
| Policy #: | 2011056 |
| Category: | Surgery |
| Initiated: | August 2011 |
| Last Review: | February 2024 |
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| Electrical Stimulation, Percutaneous Tibial Nerve Stimulation for the Treatment of Voiding Dysfunction | |
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| Description: |
Percutaneous tibial nerve stimulation (PTNS) is a technique of electrical neuromodulation used for treating voiding dysfunction.
Common causes of non-neurogenic voiding dysfunction are pelvic floor neuromuscular changes (eg, from pregnancy, childbirth, surgery), inflammation, medication (eg, diuretics, anticholinergics), obesity, and psychogenic factors. Overactive bladder is a non-neurogenic voiding dysfunction characterized by urinary frequency, urgency, urge incontinence, and nonobstructive retention.
Neurogenic bladder dysfunction is caused by neurologic damage in patients with multiple sclerosis, spinal cord injury, detrusor hyperreflexia, or diabetes with peripheral nerve involvement. The symptoms include overflow incontinence, frequency, urgency, urge incontinence, and retention.
Approaches to the treatment of incontinence differentiate between urge incontinence and stress incontinence. Conservative behavioral management such as lifestyle modification (eg, dietary changes, weight reduction, fluid management, smoking cessation) along with pelvic floor exercises and bladder training are part of the initial treatment of overactive bladder symptoms and both types of incontinence. Pharmacotherapy is another option, and different medications target different symptoms. Some individuals experience mixed incontinence.
If behavioral therapies and pharmacotherapy are unsuccessful, percutaneous tibial nerve stimulation (PTNS), sacral nerve stimulation, or botulinum toxin may be recommended.
The current indication cleared by the U.S. Food and Drug Administration (FDA) for PTNS is overactive bladder (OAB) and associated symptoms of urinary frequency, urinary urgency, and urge incontinence.
Altering the function of the posterior tibial nerve with PTNS is believed to improve voiding function and control. The mechanism of action is believed to be retrograde stimulation of the lumbosacral nerves (L4-S3) via the posterior tibial nerve located near the ankle. The lumbosacral nerves control the bladder detrusor and perineal floor.
Administration of PTNS consists of inserting a needle above the medial malleolus into the percutaneous tibial nerve followed by the application of low-voltage (10 mA, 1–10 Hz frequency) electrical stimulation that produces sensory and motor responses (i.e., a tickling sensation and plantar flexion or fanning of all toes). Noninvasive PTNS has also been delivered with surface electrodes. The recommended course of treatment is an initial series of 12 weekly office-based treatments followed by an individualized maintenance treatment schedule.
PTNS is less invasive than traditional sacral nerve neuromodulation, which has been successfully used in the treatment of urinary dysfunction but requires implantation of a permanent device. In sacral root neuromodulation, an implantable pulse generator that delivers controlled electrical impulses is attached to wire leads that connect to the sacral nerves, most commonly the S3 nerve root that modulates the neural pathways controlling bladder function.
PTNS has also been proposed as a treatment for non-neurogenic and neurogenic bladder syndromes and fecal incontinence.
Regulatory Status
In 2005, the Urgent® PC Neuromodulation System was the initial PTNS device cleared for marketing by FDA through the 510(k) process to treat patients suffering from urinary urgency, urinary frequency, and urge incontinence. The NURO™ Neuromodulation System has also been cleared for marketing through the 510(k) process.
FDA Cleared Percutaneous Tibial Nerve Stimulators (FDA Product Code: NAM):
The Urgent® PC Neuromodulation System and NURO™ Neuromodulation System are not FDA cleared for other indications, such as the treatment of fecal incontinence.
Wireless technology is evolving for the treatment of overactive bladder; it is approved in Europe. BlueWind (BlueWind Medical) is a wireless, battery-less, miniature implantable neurostimulator activated by an external device worn at the ankle.
Coding
Effective in 2011, there is a specific CPT code for this procedure:
64566: Posterior tibial neurostimulation, percutaneous needle electrode, single treatment, includes programming
Prior to 2011, the correct CPT code to use for PTNS needle insertion is the unlisted CPT code 64999. CPT codes for percutaneous implantation of neurostimulator electrodes (i.e., 64553-64565) are not appropriate since PTNS uses percutaneously inserted needles and wires rather than percutaneously implanted electrodes. The stimulation devices used in PTNS and PNT are not implanted, so CPT code 64590 is also not appropriate.
Related Policies
1998147 Electrical and/or Magnetic Stimulation, Pelvic Floor Muscles- Adult Urinary Incontinence
1998162 Sacral Nerve Stimulation for the Treatment of Urge Urinary Incontinence
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Policy/ Coverage: |
Effective October 2023
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Percutaneous tibial nerve stimulation for an initial 12-week course meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for individuals with non-neurogenic urinary dysfunction including overactive bladder who have both:
Maintenance therapy using monthly percutaneous tibial nerve stimulation meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for individuals following a 12-week initial course of percutaneous tibial nerve stimulation that resulted in improved urinary dysfunction meeting treatment goals.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Percutaneous tibial nerve stimulation for non-neurogenic urinary dysfunction not meeting the criteria listed above and for all other indications including but not limited to neurogenic bladder dysfunction and fecal incontinence does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, percutaneous tibial nerve stimulation for non-neurogenic urinary dysfunction not meeting the criteria listed above and for all other indications including but not limited to neurogenic bladder dysfunction and fecal incontinence, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective Prior to October 2023
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Percutaneous tibial nerve stimulation does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the treatment of urinary dysfunction, including but not limited to overactive bladder syndrome, urinary frequency, urgency, incontinence, and retention.
For members with contracts without primary coverage criteria, percutaneous tibial nerve stimulation is considered investigational for urinary dysfunction, including but not limited to overactive bladder syndrome, urinary frequency, urgency, incontinence, and retention. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
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| Rationale: |
Due to the detail of the rationale, the complete document is not online. If you would like a hardcopy print, please email: codespecificinquiry@arkbluecross.com
A literature search was conducted through July 2011. Following is a summary of the key literature to date:
Overactive bladder
Two randomized controlled trials (RCTs) that evaluated percutaneous tibial nerve stimulation for treating patients diagnosed with overactive bladder syndrome have been published. In addition, there is an RCT with a small number of patients evaluating percutaneous tibial nerve stimulation (PTNS) for urge incontinence, an FDA-cleared indication.
In 2009, Peters and colleagues published an industry-sponsored non-blinded comparison of PTNS and extended-release tolterodine (Detrol LA) in women with overactive bladder syndrome (the OrBIT trial) (Peters, 2009). The study included 100 patients (50 per group); more than 90% were women. Study participants were identified at 11 centers between June 2006 and September 2008. Subjects had to have symptoms of overactive bladder (OAB), with at least 8 voids per 24 hours; the mean daily voids for those entering the study were 12.3. A total of 87 of the 100 (87%) patients completed the study and voiding diary data were available for 84 patients, 41 of 50 (82%) in the PTNS group and 43 of 50 (86%) in the tolterodine group.
The primary outcome was the non-inferiority of PTNS in the mean reduction in the number of voids per 24 hours after 12 weeks of treatment. Non-inferiority was defined as no more than a 20% difference in the mean void reduction. Study findings showed non-inferiority of PTNS based on results for 84 patients. The decrease in number and standard deviation (SD) of voids per day was 2.4 (4.0) in the PTNS group and 2.5 (3.9) in the tolterodine group.
The study also reported a number of secondary outcomes, and findings on these were mixed. There were no statistically significant differences in the PTNS and tolterodine groups for other symptoms recorded in the voiding diary; this includes mean change in episodes of nocturia (-0.7 and -0.6, respectively), episodes of moderate to severe urgency per day (-2.2 and -2.9, respectively), and episodes of urge incontinence per day (-1.0 and -1.7, respectively). In other secondary outcomes, 35 of 44 patients (79.5%) in the PTNS group and 23 of 42 (54.8%) in the tolterodine group reported symptom improvement or cure. This difference was statistically significant (p=0.01), favoring the PTNS group. However, the proportion of patients reporting symptom improvement (excluding the 3 patients reporting that they were cured) did not differ significantly between groups, 34 of 44 (77.3%) of those receiving PTNS and 21 of 42 (50%) receiving tolterodine. For the adverse event data, responses were obtained in person for the PTNS group in conjunction with their weekly treatment sessions and over the phone for the medication group, using standard checklists. It is not clear how response to treatment or quality of life data were collected
Limitations of the OrBIT trial included the lack of blinding of patients and providers and the lack of comparative data beyond the end of the initial 12-week treatment period. Moreover, there was no sham or placebo group to mitigate the potential bias due to subjective outcomes. In addition, the authors did not clearly define criteria for “improvement” or “cure”, a key secondary outcome, and did not report the extent of compliance with medical therapy and used different methods of data collection in the 2 groups for adverse event outcomes and possibly also for other self-report outcomes.
In 2010, MacDiarmid and colleagues reported 1-year follow-up data for patients from the OrBIT trial who had been assigned to the PTNS group and had responded to the initial course of treatment, defined as reporting symptom improvement at 12 weeks (MacDiarmid, 2010). Thirty-three of the 35 responders were included. They received a mean of 12.1 (SD=4.9) treatments between the 12-week and 12-month visits, and there was a median of 17 days between treatments. Data were available for 32 of the 33 (97%) participants at 6 months and 25 of the 33 (76%) participants at 12 months. The mean reduction in number of voids per day from baseline (the original primary outcome of the study) was 3.2 (SD=3.7) at 6 months and 2.8 (SD=3.7) at 12 months. Other voiding diary outcomes at 12 months, based on 25 responses, were mean changes in nocturia episodes of -0.8, in episodes of moderate to severe urgency per day of -3.7, and in episodes of urge incontinence per day of -1.6. As noted above, this analysis was limited in that no data from the tolterodine group were available to compare long-term outcomes. Another limitation was that only PTNS responders were included, rather than all of the patients assigned to PTNS treatment.
The second RCT on overactive bladder syndrome, also industry-sponsored, was published by Peters and colleagues in 2010 (Peters, 2010). This study, known as the SUmiT trial, had a sham-comparison group. Prior to conducting the trial, the researchers performed a pilot study in healthy volunteers to determine the adequacy of a sham PTNS intervention (Peters, 2009). Findings were that 10 of 30 volunteers (33%) correctly identified the sham procedure. This percentage is below the 50% that could be expected by chance; the investigators concluded that the procedure was a feasible sham.
The SUmiT trial included patients with overactive bladder syndrome. The eligibility criteria included a score of at least 4 on the overactive bladder questionnaire (OAB-q) short form for urgency, self-report bladder symptoms lasting at least 3 months, and having failed conservative care. Data were collected from 23 centers in the United States. A total of 220 patients were randomly assigned, 110 to the PTNS group and 110 to the sham group. Both groups received 12 weekly 30-minute intervention sessions. In the sham group, a blunt (placebo) instrument was used to simulate the location and sensation of needle electrode insertion in active treatment. An inactive PTNS surface electrode was used and also 2 active transcutaneous electrical nerve stimulation (TENS) surface electrodes. The TENS unit was used to deliver low-level sensation to simulate the PTNS intervention. The 12-week course of treatment was completed by 103 of 110 (94%) in the PTNS group and 105 of 110 (95%) in the sham group.
The primary study outcome was response to treatment based on a single-item global response assessment (GRA) variable at 13 weeks. Possible responses were that symptoms were markedly worse, moderately worse, mildly worse, the same, slightly improved, moderately improved, or markedly improved. The proportion of patients who responded to treatment based on the GRA (i.e., answered that symptoms were moderately or markedly improved) was 60 of 110 (54.5%) in the PTNS group and 23 of 110 (20.9%) in the sham group; this difference was statistically significant, p less than 0.001. Intention-to-treat (ITT) analysis was used for the primary endpoint only. Several secondary outcomes also favored the PTNS group. The mean reduction in a symptom severity score (a lower score indicates less severity) was 36.7 (SD=21.5) in the PTNS group and 29.2 (SD=20.0) in the sham group, p=0.01. Similarly, the mean reduction in a quality of life scale, the SF-36 (a higher score indicates higher quality of life), was 34.2 (SD=21.3) in the PTNS group and 20.6 (SD=20.6) in the sham group, p=0.006.
For the 4 voiding diary variables used, there was a statistically significant difference between groups favoring PTNS. The mean change from baseline in the number of voids per day was -2.4 (SD=2.5) in the PTNS group and -1.5 (SD=2.4) in the sham group (difference between groups 0.9 voids per day, p=0.01). The mean change in nocturia episodes was -0.7 (SD=1.2) in the PTNS group and -0.3 (SD=1.4) in the sham group (difference between groups 0.4 nighttime voids, p=0.04). The mean change in moderate to severe urgency per day was -3.7 in the PTNS group and -2.0 in the sham group (difference between groups 1.7 episodes, p less than 0.001). Finally, the mean change in urge incontinence episodes was -1.3 in the PTNS group and -0.3 in the sham group (difference between groups 1 episode per day, p less than 0.002). (Standard deviations were not reported for the latter 2 outcomes)
Advantages of the SUmiT trial were that it included a sham comparison and the primary endpoint analysis was ITT. A limitation was that the primary outcome, the GRA, was a single-item subjective measure. For the more objective measures, the voiding diary variables, there was statistically significantly greater benefit with PTNS compared to sham treatment; however, the clinical significance of the difference between the PTNS and sham groups was unclear e.g., on average, there was 1 fewer episode of urge incontinence a day in the PTNS group. In addition, as in the OrBIT trial, the SUmiT trial only reported comparative data immediately following the initial course of treatment; the study did not evaluate the long-term effectiveness of PTNS. Unlike medication which can be taken on an ongoing basis, PTNS involves an initial 12-week course of treatment followed by maintenance therapy, which to date has not been well-defined. Therefore, the assumption cannot be made that short-term treatment effects will be maintained.
A search of the ClinicalTrials.gov identified a long-term extension of the SUmiT study that is underway (NCT00928385). Like the OrBIT trial extension, this study will only include patients assigned to the PTNS group who responded to treatment; it will not include additional follow-up of initial non-responders or comparative data from patients assigned to the sham-control group. Given this design, it is unlikely that the ongoing study will adequately resolve outstanding issues. It is critically important that long-term response rates reflect the patient population at the beginning of the study, not just those considered successes at 12 weeks.
In 2010, Finazzi-Agro and colleagues published an RCT from Italy with 35 female patients who had urge incontinence and detrusor overactivity on urodynamic testing (Finazzi-Agro, 2010). Patients were randomly assigned to 30-minute PTNS sessions 3 times per week for 4 weeks (n=18) or sham treatment (n=17). One patient dropped out of the PTNS group and 2 dropped out of the sham group. The primary outcome, percent responders at 4 weeks (defined as at least 50% reduction in incontinent episodes) was attained by 12/17 (71%) in the PTNS group and 0/15 (0%) in the sham group. The study did not conduct ITT analysis, was not double-blind, and did not report follow-up data beyond 4 weeks.
A Blue Cross and Blue Shield Association TEC Assessment on PTNS for treatment of voiding dysfunction was completed in December 2010. The Assessment reviewed the RCTs described above and concluded that PTNS as treatment for voiding dysfunction does not meet the TEC criteria due to insufficient data on durability of treatment. The Assessment stated that, although there is sufficient evidence from 3 RCTs to establish a short-term benefit for PTNS, the evidence is not sufficient to permit conclusions on the long-term efficacy of PTNS treatment.
No relevant national assessments, guidelines, or position statements were identified. The 2005 American College of Obstetricians and Gynecologists practice bulletin on treatment of urinary incontinence in women does not address PTNS or other types of nerve stimulation. (8) The American Urological Association does not have a guideline that addresses treatment of overactive bladder syndrome, urgency frequency, or urge incontinence.
Summary
The published evidence is insufficient to permit conclusions concerning the effect of this technology on net health outcome. Until the durability of percutaneous tibial nerve stimulation has been demonstrated in well-designed long-term comparative studies and its clinical impact more clearly shown, its efficacy for treating urinary dysfunction, a chronic condition, remains uncertain.
2012 Update
Overactive bladder
One new study, by Marchal and colleagues in Spain, addressed the timing of retreatment was identified (Marchal, 2011). This case series included a total of 53 patients with overactive bladder (OAB) unresponsive to medical treatment; 26 were included initially and 27 were added after the first year. The study did not use the 12-week treatment protocol used by the previously published RCTs. Instead, patients underwent weekly 30-minute sessions for 8 weeks, bi-weekly sessions for 8 weeks, and then monthly sessions for another 8 weeks (total of 6 months’ treatment). Cure was defined as at least a 50% decrease in the score on a 3-item incontinence symptom scale, at least a 50% decrease in the number of daytime and nighttime incontinence episodes, and at least a 50% improvement in at least 2 urodynamic parameters. Improvement was defined as at least a 25% improvement in all of the above items. Ten women (19%) received additional treatments and were excluded from the analysis. Twelve months after completing treatment, 39 of 43 (91%) remaining patients were considered to have achieved cure or improvement in their symptoms. Sixteen patients were evaluated 24 months after completing treatment. Ten (62.5%) of the 16 were considered to be improved or cured. (The authors did not report the number of cured versus improved patients at either of the time points.) Based on their findings at 24 months, the authors concluded that retreatment should be initiated after 24 months. The study was limited by the lack of a control group that did not get initial PTNS treatment, by use of a non-standard treatment protocol, by excluding patients from further analysis who received retreatments and by following only a small number of patients to 24 months.
Neurogenic bladder
In 2011, 2 case series evaluating PTNS in patients with multiple sclerosis (MS) were published. One study, by Gobbi and colleagues in the United Kingdom (U.K.) included twelve 30-minute treatment sessions with the Urgent PC device (Gobbi, 2009). The study included 21 patients with MS who had lower urinary tract symptoms unresponsive to anticholinergics. Overall, urinary symptoms significantly improved at the end of treatment. For example, median daytime frequency decreased from 9 to 6 episodes per day, p=0.04 and median nocturia decreased from 3 to 1 episode per night, p=0.002. The other case series was conducted in France by de Seze and colleagues and used a different protocol (De Seze, 2011). Participants underwent 1 in-clinic treatment session and were then given a TENS device for in-home tibial nerve stimulation; they were told to use the device 20 minutes a day for 3 months. A total of 70 individuals with MS and OAB refractory to medication participated in the study. Compared to baseline, there was a statistically significant reduction in OAB symptoms. For example, the proportion of continent patients increased from 26% to 45% (p=0.005). Both studies were limited by lack of control groups and lack of long-term follow-up; the French study used a different device and different protocol than in the other PTNS studies.
Initial research has also been published on a shortened treatment protocol (weekly 30-minute sessions for 6 weeks) using the Urgent PC device. A study by Yoong and colleagues in the U.K. included 43 women with OAB refractory to medication (Yoong, 2010). At the end of treatment, there was a response rate of 70% (defined as OAB symptoms no longer being bothersome, reduction by 50% in frequency episodes, and reduction by 25% in quality-of-life outcomes). The shortened protocol has not yet been evaluated in a randomized controlled trial.
A guideline on the diagnosis and treatment of overactive bladder in adults was published by the American Urological Association in 2012 (Gormley, 2012). The guidelines indicate that percutaneous tibial nerve stimulation may be offered as a third-line treatment option for carefully selected patients diagnosed with overactive bladder. The recommendation was given as an “Option” with evidence strength of “Grade C”. The publication defines “Option” as, “non-directive statements that leave the decision to take an action up to the individual clinician and patient because the balance between benefits and risk/burdens appears relatively equal or unclear” (Gormley, 2012). Evidence strength of “Grade C” indicates that the evidence is based on “observational studies that are inconsistent, have small sample sizes, or have other problems that potentially confound interpretation of data” (Gormley, 2012).
Summary
Percutaneous tibial nerve stimulation (PTNS) is a technique of electrical neuromodulation used for treating voiding dysfunction. The available trials report short-term improvements on measures of urinary incontinence, but the long-term effectiveness and the need for a maintenance regimen are poorly defined. Until the durability of percutaneous tibial nerve stimulation has been demonstrated in well-designed long-term comparative studies and its clinical impact more clearly shown, its efficacy for treating chronic urinary dysfunction remains uncertain.
2013 Update
A literature search was conducted using the MEDLINE database through the period of July 2013. Several key publications were identified that supported the current coverage statement. The key identified literature is summarized below.
As with the ORBIT trial, there was a SUMIT extension study including only those patients who had been assigned to the PTNS group and initially responded to treatment. That is, the extension study did not collect additional follow-up data from patients in the PTNS group who failed to meet the 12-week primary effectiveness endpoint or from patients assigned to the sham-control group. Among the 110 patients assigned to the PTNS group, 60 were initial responders and 50 of these entered the extension study (Peters, 2013; Peters, 2012). Data were available on 34 patients at 24 months and 29 patients at 36 months. After enrolling in the extension study, patients underwent a 14-week transitional protocol consisting of 2 treatments with a 14-day interval, 2 treatments with a 21-day interval and then 1 treatment after another 28 days. Following this 14-week period, a personal treatment plan was developed for each patient. PTNS treatments were delivered based on the patient’s reporting of symptoms; patients knew that PTNS sessions were available to them as needed when their symptoms increased. Between 6 and 36 months, patients received a median of 1.1 PTNS treatments per month. In a per protocol analysis, compared to baseline, 28 of 29 patients (97%) who completed the 36-month follow-up met the primary efficacy endpoint of moderate or marked improvement in overall bladder symptoms on the GRA. In addition, compared to baseline, all voiding diary measures were significantly improved in this group of patients at every 6-month follow-up. As mentioned previously in the discussion of the ORBIT extension study, the SUMIT extension study was limited by a lack of follow-up data on the control group and a lack of follow-up data on all participants in the treatment group. This design cannot rule out biases such as a placebo effect and/or that these responders represent the best response rather than the mean response.
Several other RCTs have been published; none reported on the efficacy of PTNS beyond 12 weeks. Three trials used a parallel group design. In 2010, Finazzi-Agro and colleagues from Italy was a double-blind RCT that included 35 female patients who had urge incontinence and detrusor overactivity on urodynamic testing (Finazzi-Agro, 2010). Patients were randomly assigned to 30-minute PTNS sessions 3 times per week for 4 weeks (n=18) or sham treatment (n=17). One patient dropped out of the PTNS group and 2 dropped out of the sham group; analysis was not ITT. The primary outcome, percent responders at 4 weeks (defined as at least 50% reduction in incontinent episodes) was attained by 12/17 (71%) in the PTNS group and 0/15 (0%) in the sham group. Also in 2010, Schreiner and colleagues in Brazil randomized 51 women older than 60 years who complained of urge urinary incontinence to 12 weeks of conservative treatment (Kegel exercises and bladder training) alone (n=26) or conservative treatment plus 12 weekly sessions of PTNS (n=25) (Schreiner, 2010). The response rate at 12 weeks, defined as a reduction of at least 50% in the number of incontinence episodes reported by the patient in a bladder diary, was 76% in the PTNS group and 27% in the conservative treatment only group; p=0.001. Blinding was not discussed.
In 2012, Gungor Ugurlucan and colleagues in Turkey published findings of an RCT comparing transvaginal electrical stimulation (ES) (n=38) and PTNS (n=21) in women with OAB (Gungor, 2013). The ES protocol consisted of 20-minute treatments 3 times a week for 6 to 8 weeks. PTNS was performed with an Urgent PC device used for twelve 30-minute weekly sessions. A total of 52 of 59 (88%) patients completed the study. The authors assessed numerous outcome variables and did not specify primary outcomes or adjust p values for multiple comparisons. Four bladder diary variables were reported. From baseline to the end of the treatment period, the groups did not differ significantly at the p<0.05 level in mean change in urgency episodes, nocturia or incontinence episodes. For example, the mean number of urgency episodes was 2.9 (standard deviation [SD]: 4.1) at baseline and 1.6 (SD: 0.5) after treatment in the ES group and 2.0 (SD: 3.1) at baseline and 1.3 (SD: 0.5) after treatment in the PTNS group, p=0.54. There was a statistically significant difference in daytime frequency. The mean daytime frequency was 7.8 (SD: 2.7) at baseline and 5.8 (SD: 1.9) after treatment in the ES group and 7.6 (SD: 2.6) at baseline and 7.4 (SD: 2.9) in the PTNS group (p=0.03). The authors reported that a significantly higher proportion of patients in the ES group described themselves as cured, but they did not provide proportions or p values.
One randomized trial, published in 2013, used a crossover design. This study, by Vecchioli-Scaldazza and colleagues in Italy, included 40 women with OAB (Vecchioli-Scaldazza, 2013). The treatments were PTNS (twice weekly for 6 weeks) and medication (oral solifenacin succinate 5 mg/day for 40 days), given in random order, with a 6-week wash-out period between treatments. Group A received medication first and Group B received PTNS first. The primary efficacy outcome was reduction in the number of voids in a 24-hour period. Thirty of the 40 patients (75%) completed the study. The number of daily voids significantly decreased after each treatment compared to before treatment. In Group A, the mean number of daily voids pre-medication was 11.6 (SD: 1.6) and post-medication was 10.0 (SD: 2.1), p=0.004. The mean number of voids pre-PTNS was 11.5 (SD: 1.1) and post-PTNS was 8.5 (SD: 2.3), p<0.001. In Group B, the mean number of voids pre-medication was 11.4 (SD: 1.4) and post-medication was 10.4 (SD: 1.8), p=0.008. The mean number of voids pre-PTNS was 11.4 (SD: 1.4) and post-PTNS was 9.4 (SD: 1.9), p<0.001. In addition, secondary outcomes including nocturia urge incontinence and voided volume significantly improved after each treatment compared to pre-treatment values. The authors did not directly compare the efficacy of medication and PTNS.
Systematic reviews
In 2012, 3 systematic reviews of the literature on PTNS for treating overactive bladder were published. (Burton, 2012; Levin, 2012; Moossdorff-Steinhauser, 2013) Only 1 of the 3 systematic reviews, by Burton and colleagues, conducted pooled analyses of study results (Burton, 2012). The Burton review identified 6 RCTs, the ORBIT and SUMIT trials (Peters, 2009; McDiarmid, 2010) and trial by Finazzi-Agro and colleagues, (Finazzi-Agro, 2010) all discussed above, as well as 3 RCTs only published as abstracts with sample sizes between 16 and 32 patients. A meta-analysis of data from 4 trials (2 of which were abstracts) comparing PTNS to sham treatment found a significantly higher risk of successful treatment with PTNS (risk ratio [RR]: 7.02, 95% confidence interval [CI]: 1.69 to 29.17). The confidence interval was wide, indicating a lack of precision in the pooled estimate. The SUMIT trial contributed 220 of 289 patients (76%) in the pooled analysis.
Also in 2012, the Agency for Healthcare Research and Quality (AHRQ) Effective Health Care Program published a comparative effectiveness review on the broader topic of nonsurgical treatments for urinary incontinence in adult women (Shamliyan, 2012). The review identified 4 reports of RCTs comparing PTNS and no active treatment in patients with OAB. Two of the 4 articles reported 12-week results of the sham-controlled SUMIT trial; one of these included a subgroup of SUmiT participants and was only published as an abstract. The other 2 studies consisted of the Finazzo-Agro et al. RCT, (Finazzo-Agro, 2010) which reported outcomes at 4 weeks and the Schriner and colleagues et al. RCT, (Schreiner, 2010) which reported outcomes at 12 weeks. The AHRQ report included a pooled analysis of data from 3 studies that found statistically significantly greater improvement in urinary incontinence in the PTNS compared to control group (RR: 1.9, 95% CI: 1.1 to 3.2). This pooled analysis included a total of 405 patients; 220 in the SUMIT trial, 150 in the SUMIT trial sub-analysis and 35 in the Finazzo-Agro trial. A limit of the analysis was that the 150 patients in the SUMIT sub-analysis were included twice. The AHRQ report did not discuss evidence on the efficacy of PTNS beyond 12 weeks.
In 2012, the American Urological Association (AUA) and the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction published a guideline on diagnosis and treatment of non-neurogenic overactive bladder in adults (AUA, 2012). The guideline included a statement that clinicians may offer PTNS as a third-line treatment option in carefully selected patients. The statement was rated as Grade C, indicating that the balance of benefits and risks/burdens are uncertain.
In summary, percutaneous tibial nerve stimulation (PTNS) is a technique of electrical neuromodulation used for treating voiding dysfunction. All of the available RCTs are small and short in duration, and have other methodologic weaknesses. The RCT’s report short-term (up to 12 weeks) improvements on measures of urinary incontinence, but the long-term effectiveness and the optimal maintenance regimen are poorly defined. Up to 36 months of data are available for some patients enrolled in RCTs who responded to an initial course of treatment. These patients are highly selected and a placebo response to the original and additional treatments cannot be ruled out. Long-term data are needed that reflect the patient population in an RCT that was initially randomized to the treatment and control groups. Systematic reviews of the evidence have found short-term improvements with PTNS and have not identified evidence of long-term effectiveness. Until the durability of PTNS has been demonstrated in well-designed long-term comparative studies and its clinical impact more clearly shown, its efficacy for treating chronic urinary dysfunction remains uncertain.
2014 Update
A literature search conducted through July 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Percutaneous Tibial Nerve Stimulation (PTNS) has been proposed for the treatment of overactive bladder syndrome (OAB), non-obstructive urinary retention (NOUR), neurogenic bladder, pediatric voiding dysfunction and chronic pelvic pain/painful bladder syndrome (CPP/PBS). Despite a number of publications produced in the last ten years, the role of PTNS in urinary tract dysfunctions remains unclear.
Gaziev and colleagues performed a systematic review of the papers on PTNS with the aim to better clarify potentialities and limits of this technique in the treatment of OAB syndrome and in other urological conditions (Gaziev, 2013). A literature search using MEDLINE and ISI web was performed. Search terms used were "tibial nerve" and each of the already mentioned conditions, with no time limits. An evaluation of level of evidence for each paper was performed. PTNS was found to be effective in 37-100% of patients with OAB, in 41-100% of patients with NOUR and in up to 100% of patients with CPP/PBS, children with OAB/dysfunctional voiding and patients with neurogenic pathologies. No major complications have been reported. Randomized controlled trials are available only for OAB (4 studies) and CPP/PBS (2 studies). Level 1 evidence of PTNS efficacy for OAB is available. Promising results, to be confirmed by randomized controlled studies, have been obtained in the remaining indications considered.
2015 Update
A literature search conducted through December 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Neurogenic Bladder
An RCT evaluating PTNS for neurogenic OAB in men was published by Monteiro et al in 2014 (Monteiro, 2014). Twenty-four adult men with no prior urinary symptoms who were between 6 months and 3 years poststroke were randomized to 6 weeks of PTNS twice a week or a control group that received general advice and stretching exercises. Sessions in both groups lasted 30 minutes. The proportion of patients experiencing urinary urgency, urge incontinence, and nocturnal enuresis did not differ significantly between groups immediately after treatment or at the 12-month follow-up. For example, after treatment, 8 patients (67%) in the PTNS group and 9 patients (75%) in the control group reported urge incontinence, p=0.65. Rates of nocturia did not differ between groups after treatment, but there was a significant difference at 12 months, favoring PTNS. Advantages of this study were a placebo treatment and longer-term follow-up. Findings were mostly negative, but additional studies with larger sample sizes are needed before conclusions can be drawn about the efficacy of PTNS for treatment of neurogenic bladder.
Fecal Incontinence
The Urgent PC Neuromodulation System is not FDA-cleared for the treatment of fecal incontinence. The company’s website states that the treatment can be used for this condition and that the recommended initial course of treatment includes 12 weekly sessions.
In 2014, Horrocks et al. published a systematic review of literature on tibial nerve stimulation (percutaneous and transcutaneous) to treat fecal incontinence (Horrocks, 2014). The authors included all study designs and identified a total of 12 articles, 2 RCTs and 10 case series. Six studies evaluated PTNS, 5 evaluated transcutaneous tibial nerve stimulation (TTNS), and 1 of the RCTs compared the 2 treatments. The other RCT compared TTNS with a sham treatment. Three of the 5 case series on PTNS and 1 RCT reported the outcome, 50% or greater reduction in the number of fecal incontinence episodes per week immediately after treatment. In these studies, a median of 71% of patients (range, 63%-82%) reported at least a 50% reduction in episodes. However, this analysis is limited because it lacks a control group and did not include data from all published studies.
The single RCT to date evaluating PTNS for fecal incontinence was published in 2013 by George et al in the U.K. (George, 2013). Thirty patients (28 women) who had failed conservative therapy for fecal incontinence were randomized to PTNS (n=11), TTNS ((n=11) or sham transcutaneous stimulation (n=9). Patients in all groups received a total of 12 treatments given twice-weekly sessions for 6 weeks. (This differs from the PTNS manufacturer’s recommended course of 12 weekly treatments). The primary study end point was at least a 50% reduction in the mean number of incontinence episodes per week at the end of the 6-week treatment period. Only 1 patient did not complete the study, and data were analyzed on an ITT basis. Nine of 11 patients in the PTNS group, 5 of 11 in the TTNS group, and 1 of 8 in the sham group attained the primary end point; the difference among groups was not statistically significant, p=0.035. All of the responders reported no weekly episodes of fecal incontinence after treatment. The study is limited by the small sample size and short-term follow-up.
Ongoing Clinical Trials
A search of clinicaltrials.gov on November 17, 2014 identified the following relevant ongoing RCTs on PTNS:
Comparison of PTNS and Biofeedback for Fecal Incontinence (NCT01882101): This RCT, sponsored by the Seoul National University Hospital, is randomizing patients with 2 or more weekly episodes of fecal incontinence to 6 weeks of PTNS or EMG biofeedback. The primary outcome is change in the number of weekly episodes of fecal incontinence. The investigators plan to enroll 50 patients. As of November 2014, the study has not yet started enrolling patients.
2016 Update
A literature search conducted through December 2015 did not reveal any new information that would prompt a change in the coverage statement.
Non-Neurogenic Urinary Incontinence Including Overactive Bladder
Two RCTs assessing the use of PTNS for non-neurogenic urinary incontinence were identified. A RCT comparing PTNS to medication—in this case oral solifenacin—was a crossover trial published in 2013 by Vecchioli-Scaldazza et al (Vecchioli-Scaldazza, 2013). Forty women with OAB received PTNS (twice weekly for 6 weeks) and medication, given in random order, with a 6-week washout period between treatments. Group A received medication first and group B received PTNS first. The primary efficacy outcome was reduction in the number of voids in a 24-hour period. Thirty of the 40 patients (75%) completed the study. The number of daily voids (the primary outcome) significantly decreased after each treatment compared with before treatment. In addition, secondary outcomes including nocturia urge incontinence and voided volume, significantly improved after each treatment compared with pretreatment values. The authors did not directly compare the efficacy of medication and PTNS.
A 2013 trial by Gungor Ugurlucan et al in Turkey compared transvaginal ES (n=38) and PTNS (n=21) in women with OAB (Gungor Ugurlucan, 2013). The ES protocol consisted of 20-minute treatments 3 times a week for 6 to 8 weeks. PTNS was performed with an Urgent PC device used for twelve 30-minute weekly sessions. A total of 52 (88%) of 59 patients completed the study. The authors assessed numerous outcome variables and did not specify primary outcomes or adjust p values for multiple comparisons. Four bladder diary variables were reported. From baseline to the end of the treatment period, the groups did not differ significantly at the p less than 0.05 level in mean change in urgency episodes, nocturia, or incontinence episodes. For example, the mean number (SD) of urgency episodes was 2.9 (4.1) at baseline and 1.6 (0.5) after treatment in the ES group and 2.0 (3.1) at baseline and 1.3 (0.5) after treatment in the PTNS group (p=0.54). There was a statistically significant difference in daytime frequency. The mean (SD) daytime frequency was 7.8 (2.7) at baseline and 5.8 (1.9) after treatment in the ES group and 7.6 (2.6) at baseline and 7.4 (2.9) in the PTNS group (p=0.03). The authors reported that a significantly higher proportion of patients in the ES group described themselves as cured, but they did not provide proportions or p values.
Neurogenic Bladder Dysfunction
In 2015, Schneider et al published a systematic review of literature on tibial nerve stimulation (transcutaneous and percutaneous) for treating neurogenic lower urinary tract dysfunction (Schneider, 2015). Sixteen studies were identified¾4 RCTs, 9 prospective cohort studies, 2 retrospective case series, and 1 case report. Sample sizes of the included studies were generally small; most included fewer than 50 patients and none had a sample size larger than 100 patients. Three of the 4 RCTs used transcutaneous tibial nerve stimulation and the fourth study, which was conducted in Iran, stated that PTNS was used but did not specify the device. The 4 RCTs included different study populations: women with neurogenic bladder (n=1), men with neurogenic overactive bladder (n=1), multiple sclerosis patients (n=1), and Parkinson disease patients (n=1). Comparison interventions were tolterodine, pelvic floor muscle training, lower-limb stretching, and sham (1 study each). Pooled analyses were not conducted and the systematic review mainly discussed intermediate outcomes (eg, maximum cystometric capacity, maximum detrusor pressure). In the articles reporting on RCT results (Monteiro, 2014; Perissinotto, 2015; Gaspard, 2014; Eftekhar, 2014), none reported statistically significant between-group differences in clinical outcome variables (eg, number of episodes of urgency, frequency, nocturia).
Practice Guidelines and Position Statements
American Urological Association et al
In 2014, the American Urological Association and the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction published a guideline on diagnosis and treatment of non-neurogenic overactive bladder in adults (AUA, 2015; Gormley, 2015). The guideline included a statement that clinicians may offer PTNS as a third-line treatment option in carefully selected patients. The statement was rated as grade C, indicating that the balance of benefits and risks/burdens are uncertain. (This is a revised version of a 2012 guideline; the statement on PTNS did not change).
American College of Obstetricians and Gynecologists
The 2015 American College of Obstetricians and Gynecologists practice bulletin on treatment of urinary incontinence in women did not address PTNS or other types of nerve stimulation (ACOG, 2015).
2016 Update
A literature search conducted through January 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
RCTs compared PTNS to an alternative treatment, medication, conservative therapy or electrical stimulation (ES) (Finazzi, 2010; Boudaoud, 2015; Gungor, 2013; Preyer, 2015; Vecchioli-Scaldazza 2013; Schreiner, 2010). The trials had mixed findings on short-term efficacy and none reported on the efficacy of PTNS beyond 12 weeks.
Two studies used medication treatment as the comparison intervention. In 2015, Preyer and colleagues published a non-blinded study comparing 12 weeks of PTNS versus tolterodine in 36 women with OAB (Preyer. 2015). Post treatment, there were no significant differences between groups on the reduction of incontinence episodes in 24 hours (p=0.89) or quality of life (p=0.07).
PTNS for treating Non-Neurogenic Urinary Incontinence and OAB
A number of RCTs have been published, including two key industry-sponsored RCTs, the OrBit and SUmiT trials. Systematic reviews of the evidence have found short-term improvements with PTNS and have not identified long-term comparative studies. The largest, highest quality study was the blinded sham-controlled SUmiT trial. This trial reported a statistically significant benefit of PTNS versus sham at 12 weeks. Two other sham-controlled RCTs, including one published in 2015, had mixed findings on short-term efficacy of PTNS. The non-blinded OrBit trial found that PTNS was non-inferior to medication treatment at 12 weeks. No longer-term comparative data are available after the initial 12-week treatment period. Up to 36 months of uncontrolled data are available for some patients enrolled in RCTs who responded to an initial course of treatment, but this subset of patients may not be representative of the entire study sample since it preferentially includes those with the best treatment response. This long-term uncontrolled data also does not control for a possible placebo effect and does not evaluate a uniform regimen of maintenance PTNS. As a result, the optimal maintenance regimen remains unclear.
Neurogenic Bladder
In 2015, Schneider and colleagues published a systematic review of literature on tibial nerve stimulation (transcutaneous and percutaneous) for treating neurogenic lower urinary tract dysfunction (Schneider, 2015). Sixteen studies were identified; 4 RCTs, 9 prospective cohort studies, 2 retrospective case series and 1 case report. Sample sizes of the included studies were generally small; most included fewer than 50 patients and none had a sample size larger than 100 patients. Three of the 4 RCTs used transcutaneous tibial nerve stimulation and the fourth study, which was conducted in Iran, stated that PTNS was used but did not specify the device. The 4 RCTs included different study populations; women with neurogenic bladder (n=1), men with neurogenic overactive bladder (n=1), multiple sclerosis patients (n=1) and Parkinson disease patients (n=1). Comparison interventions were tolterodine, pelvic floor muscle training, lower limb stretching and sham (1 study each). Pooled analyses were not conducted and the systematic review mainly discussed intermediate outcomes eg, maximum cystometric capacity and maximum detrusor pressure. In the articles reporting on RCT results, (Monteiro, 2024; Perissinoto, 2015; Gaspard, 2014; Eftekhar, 2014) none reported statistically significant between-group differences in clinical outcome variables eg, number of episodes of urgency, frequency or nocturia.
PTNS for Treating Neurogenic Bladder
Few RCTs evaluating tibial nerve stimulation for treating neurogenic bladder have been published to date and all but 1 performed transcutaneous stimulation rather than PTNS. Studies varied widely in factors such as the study population and comparison intervention. Study findings have not suggested that tibial nerve stimulation significantly improved incontinence symptoms and other outcomes.
The 2015 American College of Obstetricians and Gynecologists practice bulletin on treatment of urinary incontinence in women did not address PTNS or other types of nerve stimulation (ACOG, 2015).
2018 Update
A literature search conducted using the MEDLINE database through January 2018 did not reveal any new information that would prompt a change in the coverage statement.
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2019. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Tutulo et al searched the literature through December 2017 and identified 21 studies using either sacral neuromodulation (also called SNS) or PTNS to treat lower urinary tract dysfunction and chronic pelvic pain not responding to standard therapies (Tutulo, 2018). Reviewers concluded that both SNS and PTNS were effective therapies. PTNS demonstrated higher success rates (≥50% reduction in leakage episodes) and fewer side effects compared with SNS; however, longer follow-up studies with PTNS are needed. Another systematic review by Tutulo et al conducted a literature search through December 2017 of RCTs evaluating SNS and PTNS for the treatment of OAB unresponsive to standard medical therapy (Tutulo, 2018). Five RCTs were identified. Reviewers concluded that both SNS and PTNS, with success rates ranging from 61% to 90% and 54% to 79%, respectively, could be considered effective.
Simillis et al conducted a systematic review and meta-analysis comparing PTNS with SNS for the treatment of fecal incontinence (Simillis, 2018). The literature search identified 4 studies (1 RCT, 3 nonrandomized prospective studies) including 302 patients (109 undergoing SNS, 193 undergoing PTNS). The Cochrane Collaboration’s risk of bias tool was used to assess study quality. Because none of the studies blinded participants and personnel, the risk of performance and detection biases were high. Attrition and publication biases were not detected. Meta-analysis showed that patients undergoing SNS experienced significant improvements compared with patients undergoing PTNS as measured on the Wexner Fecal Incontinence Score (weighted mean difference, 2.3; 95% CI, 1.1 to 3.4) and fecal incontinence episodes per week (weighted mean difference, 8.1; 95% CI, 4.1 to 12.1).
Horrocks et al conducted a post hoc analysis of data from the CONFIDeNT trial, to evaluate factors associated with the efficacy of PTNS for fecal incontinence (Horrocks, 2017). Results from the multivariable logistic regression on the outcome of 50% improvement in weekly fecal incontinence episodes found that age, fecal urgency, stool consistency, and severity of fecal incontinence did not affect response to PTNS. Presence of obstructive defecation was the only variable that negatively affected response to PTNS (odds ratio, 0.4; 95% CI, 0.2 to 0.9). Excluding patients with obstructive defecation (n=112) resulted in a significant effect of PTNS compared with sham (49% vs 18%, p=0.002).
Sanagapalli et al conducted a retrospective chart review of consecutive patients with multiple sclerosis-related fecal incontinence who had failed conservative therapy and who were subsequently treated with PTNS (Sanagapalli, 2018). Patients (N=33) received 8 weekly treatments of PTNS, with responders receiving an additional 4 weeks of treatment. Subjects were classified as responders based on the Wexner Fecal Incontinence Score if scores at the end of treatment were either half of the baseline score or if the score was less than 10. Twenty-six (79%) of the patients were classified as responders. Responders tended to be more symptomatic at baseline and had greater improvements in quality of life scores.
American Gastroenterological Association
The American Gastroenterological Association (AGA) issued an expert review and clinical practice update on surgical interventions and device-aided therapy for the treatment of fecal incontinence (AGA, 2017). The update stated that “until further evidence is available, percutaneous tibial nerve stimulation should not be used for managing FI [fecal incontinence] in clinical practice.”
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2020. No new literature was identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
An RCT comparing PTNS with TTNS demonstrated non-inferiority in decreasing urge incontinence episodes and improving quality of life scores (Ramirez-Garcia, 2019).
Zonic-Imamovic and coworkers published the results of a RCT evaluating treatment with oxybutynin compared to transcutaneous tibial nerve stimulation (TTNS) in multiple sclerosis patients with OAB (Zonic-Imamovic, 2019). Patients were allocated to 2 groups of 30 patients each. Patients treated with anticholinergic therapy received 5 mg oxybutynin twice daily for 3 months. Patients treated with TTNS were treated at home daily for 30 minutes for 3 months. The Overactive Bladder Questionnaire (OAB-q SF) was utilized to assess the frequency of OAB symptoms and the quality of life of patients. For those treated with oxybutynin, the mean symptom subscale score improved from 61.9±6.0 to 32.4±14.8 (P<0.001) and the mean quality of life subscale score improved from 27.8±13.7 to 56.1±17.3 (P<0.001) after treatment. For those treated with TTNS, the mean symptom subscale score improved from 61.2±14.6 to 50.8±12.3 (P=0.004) and the mean quality of life subscale score improved from 28.5±12.6 to 38.3±11.4 (P=0.003). Final differences in symptoms and quality of life were found to be statistically significant between groups (P<0.001) and favored treatment with oxybutynin.
A sham-controlled, double-blind RCT of TTNS in patients with neurogenic OAB and women with non-neurogenic OAB was conducted by Welk et al from January 2016 to March 2019 (Welk, 2020). Fifty patients were recruited (OAB=20; neurogenic=30) and 24 were allocated to the sham group while 26 were allocated to active TTNS therapy. Baseline group characteristics were not specified but were noted to be similar. The majority of neurogenic OAB study participants had multiple sclerosis (22/30; 73%). The primary outcome measure was improvement of patient perception of bladder condition (PPBC). Active responders did not significantly differ between groups, numbering 3/24 (13%) in the sham group and 4/26 (15%) in the active group (P=0.77). No significant differences in secondary outcome measures (24-hour pad weight, voiding diary parameters, condition-specific patient-reported outcomes) were noted. The end-of-study marginal mean PPBC score was 3.3 (95% CI, 2.8 to 3.7) vs 2.9 (95% CI, 2.5 to 3.4) in the sham vs active groups, respectively. Findings were not stratified according to neurogenic or non-neurogenic disease. The authors concluded that TTNS does not appear to be effective for treating symptoms in individuals with neurogenic or non-neurogenic OAB.
Sarveazad et al conducted a systematic review and meta-analysis investigating the role of tibial nerve stimulation vs sham in the control of fecal incontinence (Sarveazad, 2019). A literature search conducted through December 2016 identified 5 studies including 249 patients treated with PTNS and 239 treated with sham. Studies utilizing transcutaneous stimulation were also eligible. A significant decrease in the number of fecal incontinence episodes was found in the PTNS group (standardized mean difference [SMD], -0.38; 95% CI, -0.67 to 0.10; I2=32.8%; P=0.009). However, no significant effect on incontinence scores (SMD, 0.13; 95% CI, -0.49 to 0.75; I2=88.0%; P=0.68), resting pressure (SMD, 0.12; 95% CI, -0.14 to 0.37; I2=28.8%; P=0.67), squeezing pressure (SMD, -0.27; 95% CI, -1.03 to 0.50; I2=85.5%; P=0.50), or maximum tolerable volume (SMD, -0.10; 95% CI, -0.40 to 0.20; I2=0.0%; P=0.52) was reported.
Tan et al published a systematic review and meta-analysis reporting placebo response rates in electrical nerve stimulation trials for fecal incontinence and constipation (Tan, 2019). A literature search was conducted through April 2017 identifying 10 randomized sham-controlled trials. Sham stimulation resulted in significant improvements in fecal incontinence episodes by 1.3 episodes per week (95% CI, -2.53 to -0.01; P=0.05) and Cleveland Clinic Severity Scores by 2.2 points (95% CI, 1.01 to 3.36; P=0.0003). The authors note that these findings highlight the importance of sham controls in nerve stimulation trials.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Wang et al evaluated PTNS for patients with OAB in a systematic review and meta-analysis that included 28 studies (N=2,461) (Wang, 2020). The efficacy of PTNS was compared to baseline information before treatment or other treatments (not specified). Results demonstrated that PTNS reduced the daily frequency of the following symptoms: voiding (mean difference [MD], −2.48; 95% CI, −3.19 to −1.76), nocturia (MD, −1.57; 95% CI, –2.16 to −0.99), urgency episodes (MD, −2.20; 95% CI, –3.77 to −0.62), and incontinence episodes (MD, −1.37; 95% CI, –1.71 to −1.02). Percutaneous tibial nerve stimulation also improved maximum cystometric capacity (MD, 63.76; 95% CI, 31.90 to 95.61) and compliance (MD, 7.62; 95% CI, 0.61 to 14.63). The pooled success rate was 68% (95% CI, 59% to 78%). The most common complication following PTNS was pain at the puncture site.
Xiong et al performed a systematic review with meta-analysis of 6 RCTs (N=291) evaluating the efficacy of tibial nerve stimulation (either percutaneous [ie, PTNS] or transcutaneous tibial nerve stimulation [TTNS]) versus anticholinergic medications for OAB (Xiong, 2021). There was a significant reduction in urge incontinence episodes with tibial nerve stimulation versus anticholinergic medications (MD, -1.11; 95% CI, -1.66 to -0.55). However, tibial nerve stimulation and anticholinergic medications had comparable effects on micturition, nocturia, urgency, and voided volume. Discontinuation due to adverse events was lower with tibial nerve stimulation than anticholinergic medications (odds ratio, 0.13; 95% CI, 0.03 to 0.51).
Two systematic reviews that did not include a quantitative analysis evaluated PTNS for nonobstructive urinary retention. Coolen et al evaluated 8 studies, 5 of which reported the efficacy of PTNS and 2 of transcutaneous electrical nerve stimulation (TENS) (Coolen, 2020). The objective success rate for PTNS (defined as a decrease of at least 50% in the frequency or volume of catheterization per 24 hr) was 25% to 41%. The subjective success rate (defined as the patient's request for continued chronic treatment with PTNS) ranged from 25% to 41%. A subjective success rate of 80% was reported in 1 study of women who received transvaginal TENS. Ho et al evaluated 16 studies, 5 of which reported on the efficacy of PTNS and 11 that of sacral neuromodulation (also referred to as SNM) (Ho, 2021). The success rate for PTNS (defined as at least a 50% reduction in symptoms) ranged from 50 to 60%, while the success rates for SNM (which had variable definitions across trials) ranged between 42.5% and 100% (median, 79.2%) for the test stimulation phase and 65.5% to 100% (median, 89.1%) in the long term (median follow, 42 months).
A single-center, investigator-blinded RCT compared PTNS (n=25) to anal inserts (n=25) in patients with fecal incontinence (Leo, 2021). At 3 months, a 50% reduction in weekly episodes of fecal incontinence, as calculated by a prospectively completed 2-week bowel diary, was found in 76% (19/25) of patients in the anal insert group and 48% (12/25) of patients in the PTNS group (p=.04). Both groups had similar improvements in St Mark’s fecal incontinence scores and the International Consultation on Incontinence Questionnaire.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Zyczynski et al conducted the Neuromodulation for Accidental Bowel Leakage (NOTABLe) sham-controlled trial of PTNS in women with fecal incontinence (N=166) (Zyczynski, 2022). Women with greater than or equal to 3 months of moderate-to-severe fecal incontinence were randomized to PTNS (n=111) or sham stimulation (n=55). Stimulation was delivered in 12 weekly 30-minute sessions to a single lower extremity. The primary outcome was change from baseline in St. Mark score (a 7-item, validated patient-reported outcome) measured after 12 weekly treatments. Secondary outcomes included stool consistency, bowel movement, and stool leakage episodes per week. There was no significant difference between the PTNS group (-5.3 points) and the sham group (-3.9 points) in terms of improvement from baseline in St. Mark scores (adjusted difference -1.3; 95% CI, -2.8 to 0.2). There also was no significant difference in reduction in weekly fecal incontinence episodes from baseline between the PTNS group (-2.1 episodes) and sham group (-1.9 episodes) (adjusted difference -0.26; 95% CI, -1.85 to 1.33).
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