Sling versus sphincter for post prostatectomy incontinence
| ISRCTN | ISRCTN55599282 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55599282 |
| Protocol serial number | 14690 |
| Sponsor | University College London (UK) |
| Funder | American Medical Systems |
- Submission date
- 10/09/2013
- Registration date
- 10/09/2013
- Last edited
- 15/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Antoine Kass-Iliyya
Scientific
Scientific
250 Euston Road
London
NW1 2PG
United Kingdom
| antoine.kass-iliyya@uclh.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional treatment trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A comparison of the effectiveness of the Advance male sling and AMS 800 artificial urinary sphincter for mild to moderate post prostatectomy incontinence: a single-site, two-arm randomised controlled study |
| Study objectives | A two-arm randomised comparison of the American Medical System (AMS) Advance male sling and AMS 800 artificial urinary sphincter for patients with mild and moderate post prostatectomy incontinence. |
| Ethics approval(s) | 11/0528 |
| Health condition(s) or problem(s) studied | Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Surgery |
| Intervention | Advance Male Sling, Polypropylene mesh, retrourethral transobturator position. Inserted using two needle passers and through a perineal incision. Artificial Urinary Sphincter, A mechanical device made of silicon, has three components: cuff, pump and a baloon. Implanted through a perineal incision and inguinal incision. Follow Up Length: 12 month(s) Study Entry : Single Randomisation only |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Difference in 24 hour Pad weight; Timepoint(s): 3 months, 6 months, 12 months after surgery |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 08/02/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 50 |
| Total final enrolment | 36 |
| Key inclusion criteria | 1. Post prostatectomy men at least 6 months after surgery 2. Mild to moderate stress urinary incontinence (mild 50-200 ml 1-2 pads/day; moderate 200-400 ml 3-4 pads/day) 3. Able and willing to participate in the study for its duration 4. Able to comprehend and complete health outcomes questionnaires 5. Able to understand instructions related to study procedures and give written informed consent 6. Target Gender: Male; Upper Age Limit 80 years ; Lower Age Limit 40 years |
| Key exclusion criteria | 1. Very mild incontinence (<50 ml/day; not approriate for artificial sphincter) 2. Severe incontinence (>400ml; 5 pads or more; not appropriate for male sling) 3. Previous radiotherapy for prostate cancer 4. Previous surgery for post prostatectomy incontinence or urethral stenosis 5. Urodynamics showing detrusor overactivity or compliance loss deemed a significant contributor to incontinence, or bladder outflow obstruction 6. Any unstable serious coexisting medical condition(s)) including but not limited to: myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, cerebrovascular accident or uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management within 6 months prior to Screening visit; which would preclude them from standard therapies as designated within the study design |
| Date of first enrolment | 08/02/2013 |
| Date of final enrolment | 08/02/2014 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
250 Euston Road
London
NW1 2PG
United Kingdom
NW1 2PG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | preliminary results presented at the Association of Surgeons in Training (ASiT) meeting | 01/04/2014 | 15/04/2019 | No | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
15/04/2019: The following changes have been made:
1. Publication reference added.
2. The total final enrolment has been added.
06/09/2016: No publications found, verifying study status with principal investigator.
