on-invasive evaluation of urinary bladder contractility and urethral resistance after ProACT treatment of stress urinary incontinence in men: a pilot study.
Completed
- Conditions
- stress urinary incontinenceurine stress incontinentie
- Registration Number
- NL-OMON21192
- Lead Sponsor
- Erasmus Medical Center, Department of Urology
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
1. Male ≥ 18 years of age;
2. Subjectively dry after ProACT implantation for post-prostatectomy incontinence;
Exclusion Criteria
1. Unable to urinate in a standing position;
2. Maximum urinary flow rate below 5 ml/s;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method From invasive pressure flow study (if applicable):<br /><br>1. Urethral resistance parameters (BOOI (Bladder Outlet Obstruction Index));<br /><br>2. Bladder contractility parameters (Wmax (maximum bladder contractility)).<br><br /><br /><br>From non-invasive condom catheter measurements:<br /><br>1. Isovolumetric bladder pressure (Pcond.max);<br /><br>2. URR (urethral resistance); an experimental non-invasive measure for bladder outlet obstruction, calculated from the<br>maximum condom pressure (Pcond.max) and the maximum free flow rate.
- Secondary Outcome Measures
Name Time Method From free flow-rate measurement:<br /><br>1. Maximum urinary flow-rate;<br /><br>2. Voided volume.<br><br /><br /><br>From invasive pressure flow study (if applicable):<br /><br>1. Detrusor pressure at maximum flow-rate;<br /><br>2. Maximum flow-rate;<br /><br>3. Urethral resistance parameters (URA (Urethral Resistance Factor), Average and slope of lowest part of PURR (Passive Urethral Resistance Relation));<br /><br>4. Bladder contractility parameters (BCI (Bladder Contractility Index)).<br><br /><br /><br>From non-invasive condom catheter measurements:<br /><br>1. Maximum flow-rate;<br /><br>2. Residual urine volume measured by transabdominal ultrasound;<br /><br>3. IPSS (International Prostate Symptom Score) questionnaire;<br /><br>4. QoL questionnaire.