Birmingham trial.

Trial name or title	A randomised controlled trial to assess the efficacy of laparoscopic uterosacral nerve ablation (LUNA) in the treatment of chronic pelvic pain. A multi‐centre, prospective randomised‐controlled trial with double blind assessment of outcomes
Methods
Participants	New patients presenting to the gynaecology outpatient clinic with pelvic pain (cyclical or non‐cyclical) and/or dyspareunia, and requiring diagnostic laparoscopy for evaluation of these conditions, will be invited to participate. Inclusion criteria: pelvic pain for longer than 6 months duration; pain located within the true pelvis or between and below the anterior iliac crests; associated functional disability; lack of response to medical treatment; diagnostic laparoscopy planned. Exclusion criteria: previous LUNA; mild, moderate and severe endometriosis (American Fertility Society Score >5); previous surgery for endometriosis; previous surgery for pelvic inflammatory disease; previous hysterectomy; adnexal pathology
Interventions	Diagnostic laparoscopy plus uterosacral nerve ablation (experimental group) or laparoscopy without pelvic denervation (control group).
Outcomes	Postal questionnaires including visual analogue scale for pain (primary outcome), an index of sexual satisfaction and the EuroQol 5D‐EQ instrument (secondary outcomes) will be administered at 3, 6, 12, 24 and 36 months and 5 and 10 years. The primary assessment of the effectiveness of LUNA will be from comparison of outcomes at the one‐year follow‐up, although the short‐term and longer‐term risks and benefits of LUNA will also be evaluated.
Starting date	Date ISRCTN assigned: Oct 2002
Contact information	The LUNA Trial Collaboration, Dr Pallavi Latthe. Email: pallavi.latthe@bwhct.nhs.uk
Notes	ISRCTN41196151