A randomised controlled trial to assess the efficacy of Laparoscopic Uterosacral Nerve Ablation (LUNA) in the treatment of chronic pelvic pain

ISRCTN	ISRCTN41196151
DOI	https://doi.org/10.1186/ISRCTN41196151
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Khalid Khan
Scientific

Academic Department of Obstetrics and Gynaecology
Birmingham Women's Hospital
Metchley Park Road
Edgbaston
Birmingham
B15 2TG
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	LUNA
Study objectives	1. To test the hypothesis that in women with chronic pelvic pain in whom diagnostic laparoscopy reveals either no pathology or mild endometriosis (American Fertility Society [AFS] score less than or equal to 5) LUNA alleviates pain and improves life quality at 12 months (principal objective) 2. To test the hypothesis that response to LUNA differs according to the site and cause of the pain by two secondary analyses: 2.1. Women with central pain 2.2. Women with no visible pathology 3. To explore the variation in LUNA's effectiveness and side effects at different periods of follow-up (3 and 6 months and 1, 2, 3, 5 and 10 years)
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Chronic pelvic pain in women
Intervention	1. Diagnostic laparoscopy plus uterosacral nerve ablation (experimental group) 2. Laparoscopy without pelvic denervation (control group)
Intervention type	Other
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/09/2004
Completion date	01/09/2005

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	420
Key inclusion criteria	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: 1. Pelvic pain of longer than 6 month duration 2. Pain located within the true pelvis or between and below the anterior iliac crests 3. Associated functional disability 4. Lack of response to medical treatment 5. Diagnostic laparoscopy planned
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/09/2004
Date of final enrolment	01/09/2005

Academic Department of Obstetrics and Gynaecology

Birmingham
B15 2TG
United Kingdom

University of Birmingham (UK)
University/education

Edgbaston
Birmingham
B15 2TT
England
United Kingdom

Charity

Wellbeing (UK) (ref: CF/371)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	08/12/2003		Yes	No
Results article	results	02/09/2009		Yes	No