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: 14.1 Level: LLT Classification code 10059617 Term: Overactive bladder System Organ Class: 100000004857
Conditions
Interventions
Trade Name: BOTOX
botulini toxinum typus A
(prášek pro prípravu injekcního roztoku, 100 jednotek v 1 lahvicce - powder for solution for injection, 100 units in 1 vial)
Pharmaceutical Form: Powder for
Sponsors
Adyton, s.r.o.
Eligibility
Sex/Gender
All
Inclusion 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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To determine whether bladder instillation with BOTOX embedded in TC-3 gel is effective in OAB patients according to objective and subjective parameters. 2. To determine whether bladder instillation with BOTOX embedded in TC-3 gel is superior to placebo in terms of improving subjective and objective parameters. 3. To compare the effect of BOTOX embedded in TC-3 gel to that of BOTOX embedded in TC-3 gel preceded by DMSO instillation. 4. To compare the effect of BOTOX embedded in TC-3 gel to that of DMSO instillation alone.;Secondary Objective: To assess the safety and tolerability of bladder instillation with BOTOX embedded in TC-3 gel in OAB patients.;Primary end point(s): 1. Change from baseline in the mean number of micturitions per 24 hours 2. Change from Baseline in mean number of incontinence episodes per 24 hours 3. Change from Baseline in mean number of urge incontinence episodes per 24 hours 4. Change from Baseline in mean number of urge episodes (grade 3 or 4) per 24 hours 5. Change from Baseline in mean voided volume per voiding 6. Change from Baseline in mean cystometric capacity 7. Change from Baseline in mean volume to the first involuntary detrusor contraction 8. Change from Baseline in mean maximal detrusor pressure during filling 9. Change from Baseline in mean maximal detrusor pressure during voiding 10. Change from Baseline in mean maximum flow 11. Change from Baseline in mean post-void residual volume (PVR) 12. Change from Baseline in mean projected isovolumetric detrusor pressure. 13. Change from Baseline in total Overactive Bladder Questionnaire (OABq) score 14. Change from Baseline in Patient´s Perception of Bladder Condition (PPBC) scores.;Timepoint(s) of evaluation of this end point: The primary time point comparison for all variables is at Visit V2, 4 weeks (±1 week) after the Baseline visit ("Day 0"). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of subjects reporting at least one adverse event during the study 2. Incidence and severity of adverse events.;Timepoint(s) of evaluation of this end point: At study visits V2 through V6, i.e. at week 4, week 6, week 8, week 10 and week 12 post-baseline. | — |
Countries
Czech Republic
Contacts
Public ContactClinical Research Manager
Axon CRO, s.r.o.
Outcome results
None listed