Sling versus sphincter for post prostatectomy incontinence

Phase 2

Completed

• Conditions: Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Surgery; Surgery

• Registration Number: ISRCTN55599282
• Lead Sponsor: niversity College London (UK)

Brief Summary

2014 preliminary results presented at the Association of Surgeons in Training (ASiT) meeting in https://www.sciencedirect.com/journal/international-journal-of-surgery/vol/12/suppl/S3?page-size=100&page=5 (also https://doi.org/10.1016/S1569-9056(14)60065-8) (added 15/04/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-10
• Study Completion: 2014-02-08
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 36

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in 24 hour Pad weight; Timepoint(s): 3 months, 6 months, 12 months after surgery

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration