Postoperative Levonorgestrel-Releasing Intrauterine System for Pelvic Endometriosis-Related Pain

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Postoperative levonorgestrel-releasing intrauterine system use significantly reduced dysmenorrhea and pelvic pain, and recurrence of dysmenorrhea, in endometriosis patients compared to expectant management.

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This double-blind randomized controlled trial evaluated the efficacy of a levonorgestrel-releasing intrauterine system in managing pelvic pain among 55 women with moderate-to-severe endometriosis undergoing laparoscopic conservative surgery. Patients assigned to the intrauterine device group experienced significantly greater reductions in dysmenorrhea and noncyclic pelvic pain scores at twelve months compared to those receiving expectant management, alongside improved quality-of-life metrics and lower recurrence rates. The study found no serious adverse events, indicating that the treatment is well-tolerated while effectively preventing recurrent dysmenorrhea. This paper is centrally about endometriosis — specifically postoperative medical management of pelvic pain associated with the condition.

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Abstract

OBJECTIVES: To estimate the effectiveness of a postoperative levonorgestrel-releasing intrauterine system for relieving pelvic pain in patients with endometriosis. METHODS: A double-blind randomized controlled trial was conducted in 55 patients with endometriosis and moderate-to-severe dysmenorrhea (visual analog scale, greater than 50 mm) undergoing laparoscopic conservative surgery. After surgery, patients were randomized to a levonorgestrel-releasing intrauterine system (n=28) or expectant management (n=27) group. Primary outcome was the change of dysmenorrhea visual analog scale. Secondary outcomes included changes of pelvic pain and dyspareunia visual analog scale, Short Form-36 score, and adverse effects. RESULTS: The two groups were comparable in age, body mass index, parity, and baseline pain scores. At 12 months, the levonorgestrel-releasing intrauterine system group had a significantly lower median value of dysmenorrhea and noncyclic pelvic pain score. Compared with the control group, the levonorgestrel-releasing intrauterine system group had greater reduction in dysmenorrhea visual analog scale (-81.0 compared with -50.0 mm, P=.006) and pelvic pain visual analog scale (-48.5 compared with -22.0 mm, P=.038) but a comparable reduction in dyspareunia visual analog scale (-15.0 compared with -19.0 mm, P=.831). Two patients in levonorgestrel-releasing intrauterine system group (7.4%) and nine in the expectant management group (39.1%) had recurrent dysmenorrhea within 1 year postoperatively (P=.014). Number-needed-to-treat to prevent one case with recurrent dysmenorrhea within the first year was three cases. The Short Form-36 scores improved in the levonorgestrel-releasing intrauterine system group but did not change in the expectant management group. There was no serious adverse event during the study period. CONCLUSION: The levonorgestrel-releasing intrauterine system is effective and well accepted for long-term therapy after conservative surgery for patients with moderate to severe pain related to endometriosis. It can improve the patient's quality of life, including physical and mental health.
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Objectives

To estimate the effectiveness of a postoperative levonorgestrel-releasing intrauterine system for relieving pelvic pain in patients with endometriosis.

Methods

A double-blind randomized controlled trial was conducted in 55 patients with endometriosis and moderate-to-severe dysmenorrhea (visual analog scale, greater than 50 mm) undergoing laparoscopic conservative surgery. After surgery, patients were randomized to a levonorgestrel-releasing intrauterine system (n=28) or expectant management (n=27) group. Primary outcome was the change of dysmenorrhea visual analog scale. Secondary outcomes included changes of pelvic pain and dyspareunia visual analog scale, Short Form-36 score, and adverse effects.

Results

The two groups were comparable in age, body mass index, parity, and baseline pain scores. At 12 months, the levonorgestrel-releasing intrauterine system group had a significantly lower median value of dysmenorrhea and noncyclic pelvic pain score. Compared with the control group, the levonorgestrel-releasing intrauterine system group had greater reduction in dysmenorrhea visual analog scale (−81.0 compared with −50.0 mm, P=.006) and pelvic pain visual analog scale (−48.5 compared with −22.0 mm, P=.038) but a comparable reduction in dyspareunia visual analog scale (−15.0 compared with −19.0 mm, P=.831). Two patients in levonorgestrel-releasing intrauterine system group (7.4%) and nine in the expectant management group (39.1%) had recurrent dysmenorrhea within 1 year postoperatively (P=.014). Number-needed-to-treat to prevent one case with recurrent dysmenorrhea within the first year was three cases. The Short Form-36 scores improved in the levonorgestrel-releasing intrauterine system group but did not change in the expectant management group. There was no serious adverse event during the study period.

Conclusion

The levonorgestrel-releasing intrauterine system is effective and well accepted for long-term therapy after conservative surgery for patients with moderate to severe pain related to endometriosis. It can improve the patient's quality of life, including physical and mental health. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00455845. LEVEL OF EVIDENCE: I

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Condition tags

dysmenorrheaendometriosischronic_pelvic_paindyspareunia

MeSH descriptors

Contraceptive Agents, Female Endometriosis Intrauterine Devices, Medicated Levonorgestrel Pelvic Pain Adult Contraceptive Agents, Female Double-Blind Method Dysmenorrhea Dysmenorrhea Dysmenorrhea Endometriosis Endometriosis Female Humans Laparoscopy Levonorgestrel Pelvic Pain Pelvic Pain Quality of Life

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