Transperitoneal PNS for management of adult Faecal incontinence
Research type
Research Study
Full title
Laparoscopic Trans-Peritoneal Pudendal Nerve Stimulation For Management Of Faecal Incontinence in Adults.
IRAS ID
186257
Contact name
Sushil Maslekar
Contact email
Sponsor organisation
University of Leeds
ISRCTN Number
ISRCTN49693042
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Faecal Incontinence is inability to control bowel movement causing leakage of bowel contents from back passage. It affects between 1-10% of adults with 0.5-1% experience regular faecal incontinence episodes that affect their quality of life. It is more common in females and with advancing age. This research aims to manage and improve adult faecal incontinence by stimulating the Pudendal nerve which controls the anal sphincter (back passage). A total of 20 participants, aged ≥18 years, who have experienced moderate to severe symptoms of faecal incontinence for more than 6 months and have failed conservative therapies will be selected for the study. The procedure involves placing an electrode (thin wire) on to the pudendal nerve laparoscopically (key hole surgery) under general anaesthesia. The wire is then connected to a small temporary battery taped to the lower back of participant. Regular and gentle electrical pulse are passed along the wire from the battery to stimulate the nerve. During the test period which is 2 weeks, the effectiveness of the procedure will be measured using a specially designed questionnaires to assess faecal incontinence and quality of life. All procedures will be carried out by the investigating team at St James's University Hospital.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
16/ES/0088
Date of REC Opinion
2 Sep 2016
REC opinion
Further Information Favourable Opinion