Condition category
Urological and Genital Diseases
Date applied
08/10/2002
Date assigned
08/10/2002
Last edited
03/09/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Khalid Khan

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

LUNA

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2004

Overall trial end date

01/09/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

420

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/09/2004

Recruitment end date

01/09/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Department of Obstetrics and Gynaecology
Birmingham
B15 2TG
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 3344
postmaster@bham.ac.uk

Sponsor type

University/education

Website

http://www.bham.ac.uk/

Funders

Funder type

Charity

Funder name

Wellbeing (UK) (ref: CF/371)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2003 protocol in http://www.ncbi.nlm.nih.gov/pubmed/14662012
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19724042

Publication citations

  1. Protocol

    A randomised controlled trial to assess the efficacy of Laparoscopic Uterosacral Nerve Ablation (LUNA) in the treatment of chronic pelvic pain: The trial protocol [ISRCTN41196151]., BMC Womens Health, 2003, 3, 1, 6, doi: 10.1186/1472-6874-3-6.

  2. Results

    Daniels J, Gray R, Hills RK, Latthe P, Buckley L, Gupta J, Selman T, Adey E, Xiong T, Champaneria R, Lilford R, Khan KS, , Laparoscopic uterosacral nerve ablation for alleviating chronic pelvic pain: a randomized controlled trial., JAMA, 2009, 302, 9, 955-961, doi: 10.1001/jama.2009.1268.

Additional files

Editorial Notes