Topic: Generic Health Relevance and Cross Cutting Themes
Conditions
Interventions
Advance Male Sling, Polypropylene mesh, retrourethral transobturator position.
Inserted using two needle passers and through a perineal incision.
Artificial Urinary Sp
Sponsors
University College London (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria: 1. Very mild 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in 24 hour Pad weight; Timepoint(s): 3 months, 6 months, 12 months after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed