Coverage Policy Manual
Policy #: 2004020
Category: Surgery
Initiated: May 2004
Last Review: April 2023
  Surgical Interruption of Pelvic Nerve Pathways for Primary and Secondary Dysmenorrhea

Description:
Dysmenorrhea is defined as the occurrence of painful menstrual cramps. Primary dysmenorrhea occurs in the absence of an identifiable cause, while secondary dysmenorrhea is related to an identifiable pathologic condition, such as endometriosis, adenomyosis or pelvic adhesions. The etiology of primary dysmenorrhea is incompletely understood, but is thought to be related to the overproduction of uterine prostaglandins. Therefore, first line pharmacologic therapy typically includes non steroidal anti-inflammatory drugs (NSAIDs), which reduce prostaglandin production. Oral contraceptives are another approach. Patients with secondary dysmenorrhea may be offered both NSAIDs or oral contraceptives, as well as a variety of other hormonal therapies. Patients with endometriosis frequently undergo surgery to ablate, excise or enucleate endometrial deposits or lyse pelvic adhesion. Collectively, these surgical procedures may be referred to as "conservative surgical therapy."
 
Uterine nerve ablation or presacral neurectomy are two laparoscopic surgical approaches that have been investigated as techniques to interrupt the majority of the cervical sensory nerve fibers in patients with dysmenorrhea. Uterine nerve ablation involves the transaction of the uterosacral ligaments at their insertion into the cervix, while presacral neurectomy involves the removal of the presacral nerves lying within the interiliac triangle. Presacral neurectomy interrupts a greater number of nerve pathways compared to laparoscopic uterine nerve ablation (LUNA), and is technically more demanding. Either LUNA or presacral neurectomy can be performed as adjuncts to conservative surgical therapy in patients with secondary dysmenorrhea.
 
Conservative surgical therapy includes ablation or excision of endometrial deposits or lysis of pelvic adhesions, typically performed during laparoscopy. Presacral neurectomy may be performed at the time of this laparoscopy.
 
There is no specific CPT code for laparoscopic uterine nerve ablation or presacral neurectomy. CPT code 58578 (unlisted laparoscopy procedure, uterus) may be used.  For secondary dysmenorrheal, presacral neurectomy may be performed in conjunction with either of the following procedures:
    • 58660 - Laparoscopy, surgical; with lysis of adhesions
    • 58662 - Laparoscopy, surgical; with fulguration or excision of lesions of the ovary, pelvic viscera or peritoneal surface by any method

Policy/
Coverage:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Laparoscopic nerve ablation or presacral neurectomy for the treatment of primary or secondary dysmenorrhea does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, laparoscopic nerve ablation or presacral neurectomy for the treatment of primary or secondary dysmenorrhea is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Rationale:
A literature search identified 6 randomized controlled trials focusing on either presacral neurectomy or laparoscopic uterine nerve ablation (LUNA).  Five of these trials were published prior to 1999 and were reviewed in a Cochrane report. An additional randomized study was published in 2003.  The trials vary in patient populations (i.e. primary vs. secondary dysmenorrheal) and control groups used.  In the case of secondary dysmenorrhea, conservative surgical therapy was performed with or without LUNA or presacral neurectomy. The primary outcome in all the reviewed trials was pain relief, which was measured and reported in a variety of ways. The following summarizes the results from the Cochrane review and the additional published randomized trial.
 
Primary Dysmenorrhea
 
  •  LUNA vs. Diagnostic Laparoscopy Only
The Cochrane review only identified one small randomized trial that included 10 patients in the treatment group compared to 11 in the control group.  The study reported that LUNA is associated with greater pain relief as measured with a 5 point pain scale at both 6 and 12 months, but that pain relief may decrease over time.
 
  •  LUNA vs. Presacral Neurectomy
The only randomized study in this group was a 1996 study by Chen and colleagues that randomized 68 patients to undergo either LUNA or presacral neurectomy.  The procedure was considered a success if there was at least a 50% reduction in pain. While there was no significant difference in the two procedures at 6 months, at greater than 6 months, presacral neurectomy was associated with improved pain relief compared to LUNA. However, the incidence of adverse effects was greater with presacral neurectomy; specifically 94% of patients randomized to presacral neurectomy reported constipation.
 
Secondary Dysmenorrhea
 
  •  LUNA + Conservative Surgical Therapy vs. Conservative Surgical Therapy Alone
The Cochrane review identified two randomized trials in this category, both of which reported that there was no significant improvement in pain relief by adding LUNA to conservative laser ablative therapy for endometriosis.
 
  •  Presacral Neurectomy + Conservative Surgical Therapy vs. Conservative Surgical Therapy Alone
The Cochrane review identified one randomized study of 71 patients that reported that there was no significant difference in pain relief between presacral neurectomy group and the control group.  In 2003, Zullo and colleagues reported the results of a trial that randomized 147 women with dysmenorrhea associated with endometriosis to undergo ablation of endometriosis deposits either with or without presacral neurectomy.  The primary outcome was the cure rate, defined as the percentage of patients who reported an absence of dysmenorrhea or dysmenorrhea that did not require medical treatment. At six and 12 months the cure rate for the treatment and control group was 87.3% vs. 60.3% and 85.7% vs. 57.1%, respectively. While there was no difference in short term complications between the two groups, at 12 months, 14.3% of the presacral neurectomy group reported constipation compared to none in the control group. While the results of this trial conflict with those reported by Candiani, the Candiani trial of 71 may have been underpowered to detect a significant difference.
 
Summary
There is inadequate published data to permit scientific conclusions regarding laparoscopic uterine ablation (LUNA) or presacral neurectomy in patients with primary dysmenorrhea. For patients with secondary dysmenorrhea, data suggests that the addition of LUNA to conservative surgical therapy does not result in improved pain control.  In contrast, the results of a randomized study of 147 women suggests that presacral neurectomy in conjunction with conservative surgical therapy is associated with increased pain control and cure rate.  In 2002, a group of authors published a consensus statement regarding the management of chronic pelvic pain and endometriosis.  The consensus process included a review of the literature, development of clinical recommendations, which were then discussed during a 2 day consensus meeting. The final treatment algorithms and recommendation statements were approved by unanimous or near-unanimous (>95%) votes. This consensus group offered the following recommendation regarding LUNA and presacral neurectomy.
 
"Patients with dysmenorrhea who have not responded to medical therapy may be offered presacral neurectomy at laparotomy, or if the operator is adequately experienced, via laparoscopy. Available evidence suggests that laparoscopic uterine nerve ablation does not benefit women with chronic pelvic pain associated with endometriosis."
 
2008 Update
Review of peer-reviewed medical literature through August 2008 finds no studies that would result in a change in policy.
 
2010 Update
A literature search was conducted using the MEDLINE database through October 2010.  One randomized trial was identified.  The findings of this trial do not prompt a change in the coverage statement.
 
In 2009, an additional randomized, multicenter, controlled trial from the U.K. was published comparing LUNA to a control intervention (Daniels, 2009).   The study included women who had chronic pelvic pain lasting longer than 6 months and who had not been diagnosed with moderate-to-severe endometriosis or major pelvic inflammatory disease. Forty-five percent of the sample had some type of visible pathology; 17% minimal endometriosis and 20% had adhesions. LUNA after diagnostic laparoscopy (n=243) was compared to diagnostic laparoscopy alone (n=244) for women with primary dysmenorrhea. Patients were blinded to treatment group; at the end of the study, 122 in a subsample of 211 women (58%) correctly guessed their treatment group. The primary outcome was patient-rated pain using a 10 cm visual analog scale (VAS). Patients were asked about 3 types of pain (noncyclical pain, dysmenorrhea, and dyspareunia). At 12-month follow-up, pain data were missing for 51 women (21%) in the LUNA group and 48 (20%) women in the control group; an additional 5 women in the LUNA group and 4 women in the control group withdrew consent during the first year of follow-up. Analysis was intention to treat. At 12 months, there was no significant difference between groups in any of the types of pain or in the worst pain level of any type. There was also no significant difference between groups in any of the pain outcomes when the difference in pain was measured over all timepoints (outcomes were assessed at 3 and 6 months and 1, 2, 3, and 5 years). The median time in the study was 69 months; 72% of women had at least 5 years of follow-up. Note that actual VAS scores for each group were not reported but were represented on figures. Advantages of this study include longer-term follow-up, blinding of subjective outcomes and randomization after inspection of the pelvis to ensure eligibility.
 
2012 Update
The Vanderbilt Evidence-based Practice Center, in a review done under contract to the Agency for Healthcare Research and Quality (AHRQ), systematically reviewed evidence on therapies for women age 18 and over with noncyclic chronic pelvic pain (CPP) (Andrews, 2012). They found no evidence that laparoscopic uterosacral nerve ablation (LUNA) is more effective than simple diagnostic laparoscopy and no evidence of benefit of lysis of adhesions in the studies that addressed surgical interventions. The authors concluded that a uniform definition of CPP and standardized evaluation of participants was inconsistent across the literature and improved characterization of the targeted condition, intervention, and population in CPP research is necessary. Studies reporting treatment effects offered little evidence that surgical approaches were effective; nonsurgical approaches included hormonal management of endometriosis-related CPP and were not placebo controlled. Nonhormonal and nonpharmacologic management of CPP remain understudied.
 
2015 Update
A literature search conducted through March 2015 did not reveal any new information that would prompt a change in the coverage statement.
 
2017 Update
A literature review conducted using the MEDLINE database did not reveal any new literature that would prompt a change in the coverage statement.   
 
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2018. No new literature was identified that would prompt a change in the coverage statement.
 
2019 Update
A literature search was conducted through March 2019.  There was no new information identified that would prompt a change in the coverage statement.  
 
2020 Update
A literature search was conducted through March 2020.  There was no new information 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 March 2021. No new literature was identified that would prompt a change in the coverage statement.
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2022. No new literature was identified that would prompt a change in the coverage statement.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2023. No new literature was identified that would prompt a change in the coverage statement.

CPT/HCPCS:
58578Unlisted laparoscopy procedure, uterus
58579Unlisted hysteroscopy procedure, uterus

References: Andrews J, Yunker A, Reynolds WS, et al.(2012) Noncyclic Chronic Pelvic Pain Therapies for Women: Comparative Effectiveness. Comparative Effectiveness Review No. 41. (Prepared by the Vanderbilt Evidence-based Practice Center under Contract No. 290-2007-10065-I.) AHRQ Publicaton No. 11(12)-EHC088-EF. Rockville, MD: Agency for Healthcare Research and Quality. January 2012. www.effectivehealthcare.ahrq.gov/reports/final.cfm.

Candiani GB, Vercellim P, et al.(1992) Presacral neurectomy for the treatment of pelvic pain associated with endometriosis: A controlled study. Am J Ob Gyn 1992; 167:100-103.

Chen FP, Chang SD, et al.(1996) Comparison of laparoscopic presacral neurectomy and laparoscopic uterine nerve ablation for primary dysmenorrhea. J Reprod Med Obstet Gynecol 1996; 41:463-6.

Daniels J, Gray R, Hills RK et al.(2009) Laparoscopic uterosacral nerve ablation for alleviating chronic pelvic pain. JAMA 2009; 302(9):955-61.

Gambone JC, Mittman BS, et al.(2002) Consensus statement for the management of chronic pelvic pain and endometriosis: proceeding of an expert-panel consensus process. Fertil Steril 2002; 78:961-72.

Juang CM, Chou P, et al.(2007) Laparoscopic uterosacral nerve ablation with and without presacral neurectomy in the treament of primary dysmenorrhea: a prospective efficacy analysis. J Reprod Med, 2007; 52:591-6.

Latthe PM, Proctor ML, et al.(2007) Surgical interruption of pelvic nerve pathways in dysmenorrhea: a systematic review of effectiveness. Acta Ob Gyn Scand, 2007; 86:4-15.

Lichten EM, Bombard J.(1987) Surgical treatment of primary dysmenorrhea with laparoscopic uterine nerve ablation. J Reprod Med 1987; 32:37-41.

Proctor ML, Farquhar CM, et al.(2004) Surgical interruption of pelvic nerve pathways for primary and secondary dysmenorrhoea. The Cochrane Library, Issue 1; 2004.

Vercellini P, Aimi G, et al.(1997) Laparoscopic uterosacral ligament resection for dysmenorrhea associated with endometriosis. Results of a randomized controlled trial. Fert Steril Oct Suppl 1997: S3 (abstract).

Zullo F, Palomba S, et al.(2003) Effectiveness of presacral neurectomy in women with severe dysmenorrhea caused by endometriosis who were treated with laparoscopic conservative surgery: A 1-year prospective randomized double-blind controlled trial. Am J Ob Gyn 2003; 189:5-10.

Zullo F, Palomba S, et al.(2004) Long-term effectiveness of presacral neurectomy for the treatment of severe dysmenorrhea due to endometriosis. J Am Assoc Gynecol Laparosc, 2004; 11:23-8.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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