Subject:
Surgical Interruption of Pelvic Nerve Pathways for Primary and Secondary Dysmenorrhea
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
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Two laparoscopic surgical approaches are proposed as adjuncts to conservative surgical therapy for the treatment of primary and secondary dysmenorrhea. These approaches are laparoscopic uterine nerve ablation (LUNA) and presacral neurectomy (PSN).
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Individuals:
· With primary or secondary dysmenorrhea | Interventions of interest are:
· Laparoscopic uterine nerve ablation | Comparators of interest are:
· Medication
· Conservative surgical therapy without surgical interruption of pelvic nerve pathways | Relevant outcomes include:
· Symptoms
· Treatment-related morbidity |
Individuals:
· With primary or secondary dysmenorrhea | Interventions of interest are:
· Presacral neurectomy | Comparators of interest are:
· Medication
· Conservative surgical therapy without surgical interruption of pelvic nerve pathways | Relevant outcomes include:
· Symptoms
· Treatment-related morbidity |
BACKGROUND
Dysmenorrhea is defined as painful menstrual cramps. Primary dysmenorrhea occurs in the absence of an identifiable cause, while secondary dysmenorrhea is related to an identifiable pathologic condition (eg, endometriosis, adenomyosis, 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 nonsteroidal anti-inflammatory drugs (NSAIDs), which reduce prostaglandin production. Oral contraceptives are another approach. Patients with secondary dysmenorrhea may be offered both NSAIDs and 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 adhesions. Collectively, these surgical procedures may be referred to as conservative surgical therapy.
Laparoscopic uterine nerve ablation (LUNA) and laparoscopic presacral neurectomy (PSN) are 2 surgical approaches that have been investigated to interrupt most of the cervical sensory nerve fibers in patients with dysmenorrhea. LUNA involves the transection of the uterosacral ligaments at their insertion into the cervix, while PSN involves removal of the presacral nerves within the interiliac triangle. PSN, which can be performed via open or laparoscopic approaches, interrupts a greater number of nerve pathways compared with LUNA, and is technically more demanding. Either LUNA or PSN can be performed as adjuncts to conservative surgical therapy in patients with secondary dysmenorrhea.
Regulatory Status
Laparoscopic uterine nerve ablation and presacral neurectomy are surgical procedures and, as such, are not subject to regulation by the U.S. Food and Drug Administration.
Related Policies
Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
Laparoscopic uterine nerve ablation (LUNA) and laparoscopic presacral neurectomy (LPSN) are considered investigational as techniques to treat primary or secondary dysmenorrhea.
Medicare Coverage:
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for this Service. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy.
Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.
FIDE SNP:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.
Policy Guidelines: (Information to guide medical necessity determination based on the criteria contained within the policy statements above.)
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.
[RATIONALE: This evidence review was originally created in April 2004 and has been updated regularly with searches of the MEDLINE database. Most recently, the literature was reviewed through September 7, 2018. Following is a summary of the key literature.
Laparoscopic Uterine Nerve Ablation
Systematic Reviews
In 2007, Latthe et al published a systematic review of the literature on surgical interruption of pelvic nerve pathways for primary and secondary dysmenorrhea.1 The review identified 2 randomized controlled trials (RCTs) comparing laparoscopic uterine nerve ablation (LUNA) with diagnostic laparoscopy alone.2,3 The smaller trial (N=21)2 measured pain on a 5-point scale and the other study (N=56)3 on a visual analog scale (VAS).
Pooled analysis of these trials found that, at 6 months or less follow-up, there was no significant difference between groups in pain relief (odds ratio [OR], 1.43; 95%, confidence interval [CI], 0.56 to 3.69). However, at 12 months, there was greater pain relief with LUNA (OR=6.12; 95% CI, 1.78 to 21.03). These trials included a relatively small number of women (n=68), and estimates of effectiveness were imprecise, as evidenced by wide confidence intervals.
Three trials compared LUNA plus conservative surgery to conservative surgery alone.3-5 A fourth trial compared LUNA plus laparoscopic bipolar coagulation of uterine vessels to laparoscopic bipolar coagulation of uterine vessels only for women with uterine myomas.6 No significant difference in pain relief was found in pooled analysis of 3 trials (n=190) at maximum follow-up of 6 months (OR=1.03; 95%, CI, 0.52 to 2.02) or of 2 trials (n=217) at maximum follow-up of 12 months (OR=0.77; 95%, CI, 0.43 to 1.39). There also were no significant differences between groups in quality of life, anxiety, or depression.
Randomized Controlled Trials
Additional trials since the 2007 systematic review have compared LUNA plus diagnostic laparoscopy to diagnostic laparoscopy alone. A 2009 RCT from the U.K. included women who had chronic pelvic pain lasting more than 6 months and who had not been diagnosed with moderate-to-severe endometriosis or major pelvic inflammatory disease (N=487).7 Forty-six percent of the sample had some type of visible pathology, 30% had minimal endometriosis, and 18% had adhesions. LUNA after diagnostic laparoscopy (n=243) was compared with diagnostic laparoscopy alone (n=244). The primary outcome was patient- rated pain using a 10-cm VAS score at 12 months. Patients were asked about 3 types of pain (noncyclical pain, dysmenorrhea, dyspareunia). At 12-month follow-up, pain data were missing for 51 (21%) women in the LUNA group and 48 (20%) women in the control group; another 5 women in the LUNA group and 4 women in the control group withdrew consent during the first year of follow-up. At 12 months, there was no significant difference between groups in the type of pain or in worst pain level of any type. There was also no significant difference between groups in any pain outcomes when the difference in pain was measured over all time points (3 and 6 months, and 1, 2, 3, and 5 years). Median follow-up 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 presented graphically. Strengths of this study included longer term follow-up, blinding of subjective outcomes, and randomization after inspection of the pelvis to ensure eligibility.
A 2011 RCT included women with pelvic pain and excluded those with moderate-to-severe endometriosis or previous surgery for endometriosis or for pelvic inflammatory disease.8 A total of 190 women were randomized, 95 to each group; 171 (90%) of 190 women completed 12-month follow-up. Clinical success was defined as no, minimal, or tolerable pain by patient self-report during the follow-up period without hysterectomy or repeated LUNA. At 12 months, the clinical success rate was 63 (73%) of 86 women in the LUNA group and 63 (74%) of 85 women in the control group; the difference between groups was not statistically significant. Moreover, there were no statistically significant between-group differences in dysmenorrhea or in most other efficacy variables. The only statistically significant difference, favoring the LUNA group, was in the rate of dyspareunia.
Section Summary: Laparoscopic Uterine Nerve Ablation
Several RCTs have compared conventional treatment with conventional treatment plus LUNA. The trials generally found no statistically significant differences in outcomes (eg, pain after conventional treatment plus LUNA vs LUNA alone). This evidence suggests that LUNA does not offer incremental benefit above that of conventional treatment for dysmenorrhea.
Presacral Neurectomy No RCTs were identified that evaluated presacral neurectomy (PSN) for treatment of primary dysmenorrhea.
Systematic Reviews
For secondary dysmenorrhea, several RCTs have compared PSN plus conservative surgery to conservative surgical therapy alone in patients with endometriosis.4,5,9,10 A pooled analysis of 2 trials (n=197) on secondary dysmenorrhea, reported in the Latthe systematic review (described above), found significantly greater pain relief with PSN plus surgical treatment than with surgical treatment alone at 12 months (OR=3.14; 95%, CI, 1.59 to 6.21).1
Randomized Controlled Trials
Several additional trials were published in the 1990s and early 2000s. The largest and most recent trial, published by Zullo et al in 2003, randomized 141 women and included 126 women in the analysis.10 The primary outcome was the cure rate, defined as the percentage of patients who reported an absence of dysmenorrhea or dysmenorrhea not requiring medical treatment. At 6 and 12 months, cure rates for the treatment and control groups were 87.3% versus 60.3% and 85.7% versus 57.1%, respectively. While there were no differences in short-term complications between the 2 groups, at 12 months, 14.3% of the PSN group reported constipation (vs 0% in the control group). Although trial results were favorable to PSN, several factors limit trial interpretation: All surgeries were performed by 1 physician, which raises concern whether results can be generalized. In addition, although the trial reported using intention-to-treat analysis, 15 of 141 randomized subjects were not included in the analysis.
A trial update by Zullo et al found that, at 24 months, outcomes continued to be better in the PSN group, though the overall complication rate in the PSN group continued to be higher.11 The cure rate (absence of dysmenorrhea) was higher for the PSN group (34%) than for the control laparoscopy group (18%). The percentage of women with dysmenorrhea not requiring medical attention was 82% in the PSN group and 66% in the control group. However, 11 (18%) women in the PSN group had long-term bowel and urinary dysfunction compared with none in the control group. This high complication rate raises concern about the risk-benefit ratio of adding PSN to a conservative laparoscopic therapy.
Section Summary: Presacral Neurectomy
There are no RCTs on PSN for primary dysmenorrhea and limited RCT evidence on the benefit of PSN for secondary dysmenorrhea. A pooled analysis of 2 trials (197 women) found significantly greater symptom relief with PSN plus surgery than with surgery alone at 12 months. The largest and most recent trial (2003) found significantly higher cure rates after PSN than after laparoscopy. However, adverse events (primarily constipation) were also higher following PSN. Further RCTs are needed to define better the risk-benefit ratio and the patient population that might benefit from this treatment.
Ongoing and Unpublished Clinical Trials A search of ClinicalTrials.gov in July 2016 did not identify any ongoing or unpublished trials that would likely influence this review.
Summary of Evidence For individuals who have primary or secondary dysmenorrhea who receive laparoscopic uterine nerve ablation (LUNA), the evidence includes randomized controlled trials (RCTs) and a systematic review. Relevant outcomes are symptoms and treatment-related morbidity. RCTs comparing LUNA plus conventional treatment to conventional treatment alone, and meta-analyses of these trials, have not found a consistent benefit for the addition of LUNA. Moreover, RCT sample sizes have tended to be small, and few studies have followed patients beyond 12 months. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals who have primary or secondary dysmenorrhea who receive presacral neurectomy (PSN), the evidence includes RCTs and a systematic review. Relevant outcomes are symptoms and treatment-related morbidity. No RCTs on primary dysmenorrhea were found and there are only a few on secondary dysmenorrhea. A pooled analysis of 2 trials with a total of 197 women with secondary dysmenorrhea associated with endometriosis found significantly greater symptom relief with PSN plus surgery than with surgery alone at 12 months. The largest and most recent trial (2003) found improvement in pain outcomes, but also higher complication rates with PSN; this trial also had methodological limitations that limit interpretation of its findings. The net health benefit remains unclear and needs to be further assessed in additional trials. The evidence is insufficient to determine the effects of the technology on health outcomes.
SUPPLEMENTAL INFORMATION
Practice Guidelines and Position Statements
In 2007, the National Institute for Health and Clinical Excellence issued interventional procedure guidance number 234 on LUNA for chronic pelvic pain.12 The guidance stated: “The evidence on laparoscopic uterine nerve ablation (LUNA) for chronic pelvic pain suggests that it is not efficacious and therefore should not be used.”
U.S. Preventive Services Task Force Recommendations
Not applicable.]
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Surgical Interruption of Pelvic Nerve Pathways for Primary and Secondary Dysmenorrhea
Laparoscopic Presacral Neurectomy
Laparoscopic Uterine Nerve Ablation
LPSN (Laparoscopic Presacral Neurectomy)
LUNA (Laparoscopic Uterine Nerve Ablation)
Presacral Neurectomy
References:
1. Latthe PM, Proctor ML, Farquhar CM, et al. Surgical interruption of pelvic nerve pathways in dysmenorrhea: a systematic review of effectiveness. Acta Obstet Gynecol Scand. 2007;86(1):4-15. PMID 17230282
2. Lichten EM, Bombard J. Surgical treatment of primary dysmenorrhea with laparoscopic uterine nerve ablation. J Reprod Med. Jan 1987;32(1):37-41. PMID 2951520
3. Johnson NP, Farquhar CM, Crossley S, et al. A double-blind randomised controlled trial of laparoscopic uterine nerve ablation for women with chronic pelvic pain. Bjog. Sep 2004;111(9):950-959. PMID 15327610
4. Tjaden B, Schlaff WD, Kimball A, et al. The efficacy of presacral neurectomy for the relief of midline dysmenorrhea. Obstet Gynecol. Jul 1990;76(1):89-91. PMID 2193272
5. Vercellini P, Aimi G, Busacca M, et al. Laparoscopic uterosacral ligament resection for dysmenorrhea associated with endometriosis: results of a randomized, controlled trial. Fertil Steril. Aug 2003;80(2):310-319. PMID 12909493
6. Sutton C, Pooley AS, Jones KD, et al. A prospective, randomized, double-blind controlled trial of laparoscopic uterine nerve ablation in the treatment of pelvic pain associated with endometriosis. Gynaecol Endosc. 2001;10(4):217-222. PMID
7. Daniels J, Gray R, Hills RK, et al. Laparoscopic uterosacral nerve ablation for alleviating chronic pelvic pain: a randomized controlled trial. Jama. Sep 2 2009;302(9):955-961. PMID 19724042
8. El-Din Shawki H. The efficacy of laparoscopic uterosacral nerve ablation (LUNA) in the treatment of unexplained chronic pelvic pain: a randomized controlled trial. Gynecol Surg. Feb 2011;8(1):31-39. PMID 21461043
9. Candiani GB, Fedele L, Vercellini P, et al. Presacral neurectomy for the treatment of pelvic pain associated with endometriosis: a controlled study. Am J Obstet Gynecol. Jul 1992;167(1):100-103. PMID 1442906
10. Zullo F, Palomba S, Zupi E, et al. 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 Obstet Gynecol. Jul 2003;189(1):5-10. PMID 12861130
11. Zullo F, Palomba S, Zupi E, et al. Long-term effectiveness of presacral neurectomy for the treatment of severe dysmenorrhea due to endometriosis. J Am Assoc Gynecol Laparosc. Feb 2004;11(1):23-28. PMID 15104826
12. National Institute for Health and Clinical Evidence (NICE). Laparoscopic uterine nerve ablation (LUNA) for chronic pelvic pain [IPG234]. 2007; https://www.nice.org.uk/guidance/ipg234. Accessed July 27, 2016.
13. Smith RP, Kaunitz AM. Treatment of primary dysmenorrhea in adult women. In: UpToDate, Barbieri RL, Eckler K (Eds), UpToDate, Waltham, MA. (Accessed on October 9, 2017.)
14. Barbiere RL. Treatment of chronic pelvic pain in women. In: UpToDate, Sharp ST, Eckler K (Eds), UpToDate, Waltham, MA. (Accessed on October 9, 2017.)
15. Schenken, RS. Endometriosis: Treatment of pelvic pain. In: UpToDate. Eckler K (Eds), UpToDate, Waltham, MA. (Accessed on September 7, 2018.)
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