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A Randomized Controlled Trial

Jane Daniels, MSc; Richard Gray, MSc; Robert K. Hills, PhD; Pallavi Latthe, MD; Laura Buckley, PhD; Janesh Gupta, MD, MSc; Tara Selman, PhD; Elizabeth Adey, BSc; Tengbin Xiong, PhD; Rita Champaneria, MPhil; Richard Lilford, PhD; Khalid S. Khan, MD, MSc; on behalf of the LUNA Trial Collaboration

JAMA. 2009;302(9):955-961.

Context  Chronic pelvic pain is a common condition with a major effect on health-related quality of life, work productivity, and health care use. Operative interruption of nerve trunks in the uterosacral ligaments by laparoscopic uterosacral nerve ablation (LUNA) is a treatment option for patients with chronic pelvic pain.

Objective  To assess the effectiveness of LUNA in patients with chronic pelvic pain.

Design, Setting, and Participants  Randomized controlled trial of 487 women with chronic pelvic pain lasting longer than 6 months without or with minimal endometriosis, adhesions, or pelvic inflammatory disease, who were recruited to the study by consultant gynecological surgeons from 18 UK hospitals between February 1998 and December 2005. Follow-up was conducted by questionnaires mailed at 3 and 6 months and at 1, 2, 3, and 5 years.

Intervention  Bilateral LUNA or laparoscopy without pelvic denervation (no LUNA); participants were blinded to the treatment allocation.

Main Outcome Measures  The primary outcome was pain, which was assessed by a visual analogue scale. Data concerning the 3 types of pain (noncyclical pain, dysmenorrhea, and dyspareunia) were analyzed separately as was the worst pain level experienced from any of these 3 types of pain. The secondary outcome was health-related quality of life, which was measured using a generic instrument (EuroQoL EQ-5D and EQ-VAS).

Results  After a median follow-up of 69 months, there were no significant differences reported on the visual analogue pain scales for the worst pain (mean difference between the LUNA group and the no LUNA group, –0.04 cm [95% confidence interval {CI}, –0.33 to 0.25 cm]; P = .80), noncyclical pain (–0.11 cm [95% CI, –0.50 to 0.29 cm]; P = .60), dysmenorrhea (–0.09 cm [95% CI, –0.49 to 0.30 cm]; P = .60), or dyspareunia (0.18 cm [95% CI, –0.22 to 0.62 cm]; P = .40). No differences were observed between the LUNA group and the no LUNA group for quality of life.

Conclusion  Among women with chronic pelvic pain, LUNA did not result in improvements in pain, dysmenorrhea, dyspareunia, or quality of life compared with laparoscopy without pelvic denervation.

Trial Registration  controlled-trials.com Identifier: ISRCTN41196151

Author Affiliations: Department of Obstetrics and Gynecology (Mss Daniels and Champaneria and Drs Gupta and Khan), Birmingham Women's Hospital (Mss Daniels and Champaneria and Drs Latthe, Gupta, Selman, and Khan), Birmingham Clinical Trials Unit, Robert Aitken Institute (Ms Daniels and Mr Gray), CRUK Clinical Trials Unit (Dr Buckley), and Department of Public Health (Dr Lilford), University of Birmingham, Birmingham, England; Department of Hematology, School of Medicine, Cardiff University, Cardiff, Wales (Dr Hills); Heart of England NHS Foundation Trust, Birmingham, England (Ms Adey); and Faculty of Health, University of East Anglia, Norwich, England (Dr Xiong).

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