Condition category
Signs and Symptoms
Date applied
20/04/2016
Date assigned
20/04/2016
Last edited
05/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Faecal incontinence is the inability to control bowel movement, causing leakage of bowel contents from the back passage. It affects between 1-10% of adults, with 0.5-1% experiencing regular faecal incontinence episodes that affect their quality of life. It is more common in women and with advancing age. This study aims to manage and improve adult faecal incontinence by stimulating the pudendal nerve which controls the anal sphincter (back passage).

Who can participate?
Patients aged 18 or over who have experienced moderate to severe symptoms of faecal incontinence for more than 6 months and have not responded to conservative treatments

What does the study involve?
The procedure involves placing an electrode (thin wire) on to the pudendal nerve laparoscopically (keyhole surgery) under general anaesthesia. The wire is then connected to a small temporary battery taped to the lower back of the participant. Regular and gentle electrical pulses are passed along the wire from the battery to stimulate the nerve. During the test period of 2 weeks, the effectiveness of the procedure is measured using a specially designed questionnaire to assess faecal incontinence and quality of life.

What are the possible benefits and risks of participating?
This procedure aims to improve the symptoms of faecal incontinence and quality of life. It provides an alternative option for those patients who have failed to improve with conservative management and SNS (currently the preferred and approved surgical management of faecal incontinence). General complications include: heart and lung complications, temporary urinary retention (inability to pass urine), and deep vein thrombosis (blood clots). Complications related to the general anaesthetic include: wound infection and haematoma (collection of blood), haemorrhage (bleeding more than anticipated), failure of surgical equipment, and injury to other organs in the pelvis. Device-related complications include: failed implant procedure, wound infection, electrode (lead) dislodgement, lead migration/fragmentation (movement of lead), neurological pains in the legs, perineum and vagina, pain at the battery site due to non-infective cause such as battery rotation, and lack or loss of effectiveness (reduced or lost response after operation).

Where is the study run from?
St James's University Hospital (UK)

When is the study starting and how long is it expected to run for?
September 2016 to September 2017

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Mr Ibrahim Eltilib
i.eltilib@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Mr Sushil Maslekar

ORCID ID

Contact details

Ground Floor
Lincoln Wing
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
+44 (0)113 243 3144
sushil.maslekar@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Laparoscopic trans-peritoneal pudendal nerve stimulation for management of faecal incontinence in adults

Acronym

Study hypothesis

Pudendal nerve stimulation is effective for management of faecal incontinence.

Ethics approval

REC2 East of Scotland, 02/09/2016, ref: 16/ES/0088

Study design

Prospective UK single-site feasibility study

Primary study design

Interventional

Secondary study design

Feasibility study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Faecal incontinence

Intervention

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 pulses 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.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. Short-term safety and efficacy (Cleveland Clinic Incontinence Score (CCIS))
2. Impact on Quality of Life (QoL)
Measured prior to the surgery and 2 weeks after surgery.

Secondary outcome measures

1. Difference in the percentage of successes, as defined by the device in use and ≥ 50% improvement in the Cleveland Clinic Incontinence Score (CCIS), between pre-operative and 2 weeks post intervention
2. The safety of pudendal nerve stimulation as judged by explant rates and operative and post-operative complications
3. The effect on disease-specific QoL (Faecal Incontinence Quality of life Score (FiQol)) and overall QoL (SF-12 score)

Overall trial start date

01/09/2016

Overall trial end date

01/09/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with moderate to severe faecal incontinence for more than 6 months and suffering ≥ two incontinence episodes per week
2. Patients should have had a trial of conservative management plus either be suitable for trial of sacral nerve stimulation (SNS) or have had unsuccessful outcome with trial of SNS
3. Patients willing to participate in this study
4. Age ≥18 years
5. Able to provide written and informed consent
6. Suitable candidate for surgery
7. Able and willing to comply with terms of the protocol including filling in questionnaires

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10

Participant exclusion criteria

1. Presence of anal sphincter augmentation device i.e. FENIX or ABS
2. Chronic gastro-intestinal motility disorder causing incontinence due to diarrhoea
3. Active anorectal sepsis or disease such as cancer
4. External rectal prolapse
5. Pregnancy
6. Suspected or known allergy to titanium
7. Multiply scarred abdomen precluding laparoscopic surgery

Recruitment start date

01/09/2016

Recruitment end date

01/09/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

Faculty Research Ethics and Governance Administrator
Faculty Research Office
Room 10.110
Level 10
Worsley Building
Clarendon Way
Leeds
LS2 9JT
United Kingdom
+44 (0)113 343 7587
governance-ethics@leeds.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The result of this study will be published in scientific journals. This study is also part of MD (Doctor of Medicine) degree project.

Intention to publish date

01/09/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes