Effect on the contractions of the bladder muscle of one single vaginal application of 2 mL of V0162 gel (dosed at 0.8%) in post-menopausal women with hyperactivity of bladder function (imperious mictions).
- Conditions
- Overactive Bladder symptoms.Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2010-024271-10-PL
- Lead Sponsor
- PIERRE FABRE MEDICAMENT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 36
- Female aged 18 years and above,
- Post-menopausal female: the postmenopause is defined as the time after which a woman has experienced twelve (12) consecutive months of amenorrhea (lack of menstruation).
- Non neurogenic overactive bladder symptoms defined by urinary frequency (>= 8 micturitions per 24h), urgency (at least one episode per 24 hours), urgency incontinence (at least one episode of incontinence per 24h), and nocturia (at least one episode per 24h),
- Symptoms of overactive bladder for 6 months or more,
- Urodynamically confirmed detrusor overactivity : defined as a phasic increase in detrusor pressure of at least 5 cm of water in the presence of typical symptoms
- Maximum urinary flow rate (Q max) >=15mL/s at randomization visit,
- Responders to prior antimuscarinic therapy within one year,
- Negative urine culture,
- Patient accepting to participate in the study and able to understand and sign an approved Informed Consent Form,
- Patient able to understand the protocol and to come to the control visits,
- Patient who, in the judgement of the investigator is likely to be compliant during the study,
- If required by national regulation, patient registered with a social security or health insurance system.
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
* Criteria related to pathologies
- Stress incontinence diagnosed by positive cough test,
- Total voided volume greater than 3000 ml on average per 24 hours on the two days prior to the randomization visit,
- Concurrent urinary tract infection, urinary tract infection within 30 days of screening or history of chronic or recurrent urinary tract infections, defined as two or more episodes per year,
- Interstitial cystitis,
- Haematuria,
- Current or history (within two years) of bladder neoplasm or malignancies likely to contribute to urinary dysfunction, including bladder, uterine, or cervical cancer,
- Urinary tract calculi, urinary retention or other evidence of poor detrusor function,
- Bladder outlet obstruction,
- Bladder electrostimulation within 3 months before the randomization visit,
- Bladder training therapy within 3 months before the randomization visit,
- Intermittent self-catherization,
- Neuropathology that could affect the lower urinary tract or its nerve supply including, but not limited to, Parkinsonism, multiple sclerosis or spinal cord injury,
- Past history of risk of urinary retention,
- Genital bleeding of unknown origin,
- Current vaginal infection requiring medication,
- Urogenital surgery within 6 months before the randomization visit,
- Concomitant treatment with a medicinal product known to prolong the QT interval,
- Patients with congenital long QT syndrome,
- Patients with a known or suspected prolongation of the QT interval or an electrolyte imbalance, in particular reduced serum potassium,
- Clinically significant bradycardia,
- Diabetes mellitus,
- History of severe hepatic insufficiency,
- History of epilepsy,
- History of closed angle glaucoma.
* Criteria related to treatments
- History of hypersensitivity to mequitazine or excipients (Sodium benzoate, Potassium sorbate),
- Contraindication to anti-muscarinic treatment,
- Anticholinergic drugs treatment within 7 days for oxybutynin, tolterodine and darifenacine, 14 days for solifenacine before the randomization visit,
- Drugs known to prolong the QT interval, such as quinidine, amiodarone, macrolides by the IV route, or moxifloxacin,
- History of agranulocytosis related or not to intake of other phenothiazine-derived compounds.
* Criteria related to the population
- History of major medical (including psychiatric) illness or surgery which, in the judgement of the investigator, puts them ‘at risk’ or is likely to modify their handling of the study drug,
- Patient’s refusal to avoid sexual intercourse between Day1 and Day2,
- Patients working at night
- Participation to another clinical trial in the two previous months or during the study,
- Patient who has forfeited her freedom by administrative or legal decision, or who is under guardianship.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine urodynamic effects of one single vaginal application of 2 mL of 0.8% V0162 gel over 24 hours in post-menopausal female patients with OAB.;<br> Secondary Objective: - To evaluate the Lower urinary tract symptoms (LUTS) of one single vaginal application of 2 mL of 0.8% V0162 gel in post-menopausal female patients with OAB.<br> - To evaluate clinical and biological tolerability of 2 mL of 0.8% V0162 gel in post-menopausal female patients with OAB.<br> ;<br> Primary end point(s): The number of detrusor contractions before application and at 2 and 24 hours after one single vaginal application of V0162 gel.<br> ;Timepoint(s) of evaluation of this end point: T0, T2h, T24h
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): To evaluate the Lower urinary tract symptoms (LUTS) of one single vaginal application of 2 mL of 0.8% V0162 gel in post-menopausal female patients with OAB.<br> To evaluate clinical and biological tolerability of 2 mL of 0.8% V0162 gel in post-menopausal female patients with OAB.<br> ;Timepoint(s) of evaluation of this end point: T0, T24h