Stimulation of pudendal nerve for management of adult faecal incontinence using key hole surgery
| ISRCTN | ISRCTN49693042 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49693042 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/04/2016
- Registration date
- 20/04/2016
- Last edited
- 05/09/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
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
Contact information
Scientific
Ground Floor, Lincoln Wing
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
| Phone | +44 (0)113 243 3144 |
|---|---|
| sushil.maslekar@nhs.net |
Study information
| Study design | Prospective UK single-site feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Feasibility study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Laparoscopic trans-peritoneal pudendal nerve stimulation for management of faecal incontinence in adults |
| Study objectives | Pudendal nerve stimulation is effective for management of faecal incontinence. |
| Ethics approval(s) | REC2 East of Scotland, 02/09/2016, ref: 16/ES/0088 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/09/2016 |
| Completion date | 01/09/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 10 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2016 |
| Date of final enrolment | 01/09/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Leeds
LS9 7TF
United Kingdom
Sponsor information
University/education
Faculty Research Ethics and Governance Administrator
Faculty Research Office, Room 10.110, Level 10
Worsley Building, Clarendon Way
Leeds
LS2 9JT
England
United Kingdom
| Phone | +44 (0)113 343 7587 |
|---|---|
| governance-ethics@leeds.ac.uk | |
"ROR" |
https://ror.org/024mrxd33 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/09/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
