EUCTR2012-005344-15-CZ
Active, not recruiting
Phase 1
A Double Blind Study Aiming To Evaluate The Efficacy Of Bladder Instillation With Botulinum Toxin (200U) + TC-3 Gel In Comparison To Instillation With Botulinum Toxin (200U) + TC-3 Gel + DMSO, To DMSO Instillation and To Saline Instillation As Placebo In Overactive Bladder (OAB) Patients.
Adyton, s.r.o.0 sitesJanuary 8, 2013
ConditionsOveractive bladder (OAB) syndrome (in women), as defined by the International Continence Society (ICS): severe urgency with or without urge urinary incontinence, usually accompanied with increased daytime frequency and nocturia, in the absence of urinary tract infection or other obvious patology.MedDRA version: 14.1Level: LLTClassification code 10059617Term: Overactive bladderSystem Organ Class: 100000004857Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
DrugsBOTOX
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Overactive bladder (OAB) syndrome (in women), as defined by the International Continence Society (ICS): severe urgency with or without urge urinary incontinence, usually accompanied with increased daytime frequency and nocturia, in the absence of urinary tract infection or other obvious patology.
- Sponsor
- Adyton, s.r.o.
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •At screening:
- •1\. Female subject \= 18 years of age
- •2\. Signed Independent Ethical Committee (IEC) approved informed consent is obtained from the subject (prior to any study\-related procedures, including withdrawal of prohibited medication, if applicable).
- •3\. Subject is willing and able to complete the micturition diary and questionnaires correctly.
- •4\. Subject has symptoms of OAB for \= 3 months prior to the Screening Visit.
- •At Randomization:
- •1\. Subject experiences at least 3 episodes of severe urgency (grade 3 or 4\) with or without incontinence during the 3\-day micturition diary period.
- •2\. Subject experiences frequency of micturition on average \= 8 times per 24\-hour period during the 3\-day micturition diary period.
- •3\. Subject is willing and able to complete the micturition diary and questionnaires correctly.
- •Are the trial subjects under 18? no
Exclusion Criteria
- •At Screening:
- •1\. The pregnancy test (HCG in urine) taken at screening visit is positive in women of childbearing positional.
- •2\. Female subject is breastfeeding, pregnant, intends to become pregnant during the study or of childbearing potential and sexually active and not practicing a highly reliable method of birth control.
- •3\. Subject in the opinion of the investigator has clinically significant Bladder Outlet Obstruction (BOO).
- •4\. Subject has post\-void residual volume (PVR) \>200 mL.
- •5\. Subject has neurogenic bladder.
- •6\. Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator (confirmed by a cough provocation test).
- •7\. Subject has an indwelling catheter or practices intermittent self\-catheterization.
- •8\. Subject has diabetic neuropathy.
- •9\. Subject has evidence of a symptomatic urinary tract infection (urine Dipstick with nitrites present), chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs.
Outcomes
Primary Outcomes
Not specified
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