The Effect of Botox Applied in TC-3 Gel in Patients Suffering From Overactive Bladder.

Phase 1

• 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.; MedDRA version: 14.1Level: LLTClassification code 10059617Term: Overactive bladderSystem Organ Class: 100000004857; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2012-005344-15-CZ
• Lead Sponsor: Adyton, s.r.o.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-08
• Last Update Posted: 21 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

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
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 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13

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.
10. Subject receives non-drug treatment including electro-stimulation therapy (with the exception of a bladder training program or pelvic floor exercises which started more than 30 days prior to screening).
11. Subject has any other clinically significant condition, which in the opinion of the investigator makes the subject unsuitable for the study.
12. Subject did not respond to previous anticholinergic treatment.

At Randomization:¨
1. The pregnancy test (HCG in urine) taken at the Baseline Visit is positive in women of childbearing potential.
2. Female subject is breastfeeding, pregnant, intends to become pregnant during the study or of childbearing potential is sexually active and not practicing a highly reliable method of birth. control.
3. Subject has evidence of a symptomatic urinary tract infection (urine Dipstick with nitrites present)
4. Subject has any other clinically significant condition, which in the opinion of the investigator makes the subject unsuitable for the study.

Study & Design

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