Exploratory study of besipirdine efficacy and safety in male patients with persistent stress urinary incontinence after radical prostatectomy

Phase 1

• Conditions: Persistant stress urinary incontinence further to radical prostatectomy; MedDRA version: 12.0Level: LLTClassification code 10046543Term: Urinary incontinence

• Registration Number: EUCTR2009-014049-10-FR
• Lead Sponsor: Institut de Recherche Pierre Fabre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-08
• Study Completion: 2010-07-12
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

- Male out patients,
- Aged =40 and = 80 years,
- Stress urinary incontinence following radical prostatectomy (for prostate cancer) persistent for at least 12 months and stable for at least 6 months prior to selection visit,
- Using pads for Stress Urinary Incontinence,
- Pad weight between 10 and 75 g at 24-hour home Pad Test (average weight of the 24-hour home pad test performed for 3 consecutive days within the 7 days prior to the inclusion visit),
- Life expectancy of at least 6 months
- Having signed his informed consent form,
- Patient able to fill in self-questionnaires,
- Affiliated to a social security system, or is a beneficiary
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Mixed incontinence with predominant Overactive Bladder
- Urinary incontinence prior to prostatectomy,
- Neurological pathology that affects the lower urinary tract (Spinal cord lesions, multiple sclerosis, Parkinson’s disease, Diabetes Mellitus ….),
- Adult nocturnal enuresis,
- Recent urethral pathology (<6 months) such as fistula, diverticulosis, stenosis,
- Recent radiotherapy (<6 months)
- Absence of voluntary micturition (permanent leakage),
- Polyuria (urinary volume > 3 l/day),
- Recurrent urinary infection (every 6 months or less),
- Perineal reeducation on-going or stopped less than 3 months prior to selection,
- Bad compliance in patient diary completion during the run-in period (i.e. data reported less than 3 consecutive days),
- Bradycardia (resting HR<50 bpm),
- Arterial Hypertension (defined as SBP>140 mmHg and/or DBP>90 mmHg or uncontrolled and not stable),
- Any clinically significant cardiac arrhythmia or conduction disturbance,
- Evidence of active liver disease (levels of AST or ALT> 2 times the upper normal laboratory value and/or alkaline phosphatase > 1,5 times the upper normal laboratory value)
- Intake of any treatment known to have an activity on urethral sphincter or detrusor (e.g. anticholinergic, antidepressants, a-stimulants…)
- Recent start or dosage modification of anti-androgen treatment (< 6 months)
- Patient known to be non responder to NSRI,
- Bad compliance to study drug intake during the run-in period (i.e. less than 70%),
- Alcohol or drug abuse or dependence,
- Is a family member or work associate (secretary, nurse, technician,…) of the Investigator,
- Has participated in another clinical trial within the last 3 month(s), has received treatment with known remnant effects or undergone investigation liable to interfere with the present clinical trial,
- Mentally unable to understand the nature, objectives and possible consequences of the trial; or refusing to subject himself to its constraints,
- Has forfeited his freedom by administrative or legal award or is under guardianship.
- Known lactose intolerance,

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified