Persistant stress urinary incontinence further to radical prostatectomy MedDRA version: 12.0 Level: LLT Classification code 10046543 Term: Urinary incontinence
Conditions
Interventions
Product Name: besipirdine hydrochloride
Product Code: HP749
Pharmaceutical Form: Capsule*
INN or Proposed INN: besipirdine hydrochloride
Current Sponsor code: HP749
Concentration unit: mg milligram(s)
Sponsors
Institut de Recherche Pierre Fabre
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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 ( 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 HR140 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,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the clinical efficacy of besipirdine (20 mg b.i.d.) compared to placebo in male patients with persistent stress urinary incontinence further to radical prostatectomy;Secondary Objective: To assess the tolerability of besipirdine (20 mg b.i.d.) compared to placebo in male patients with persistent stress urinary incontinence further to radical prostatectomy;Primary end point(s): Efficacy : Leakage volume at 24-hour home Pad test (dry, responder rate, mean volume)Patient Global Impression (PGI) of severity and of change. | — |
Countries
France
Outcome results
None listed