Overactive bladder treatment by Intravaginal injection of botulinum toxin A
Phase 3
Recruiting
- Conditions
- overactive bladder.
- Registration Number
- IRCT20211203053261N1
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 50
Inclusion Criteria
Adult women with overactive bladder who have not responded to initial medical treatment
Exclusion Criteria
Age under 18 years
patients with neurogenic bladder (known cases of neurological defects)
Active UTI
Women with intact Hymen
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ICIQ-OAB symptom score. Timepoint: Before and 4 weeks after intervention. Method of measurement: Validated questionnaire.
- Secondary Outcome Measures
Name Time Method Pain severity. Timepoint: Before and 4 weeks after intervention. Method of measurement: VAS score.;Incidence of gross hematuria. Timepoint: Within a week after the intervention. Method of measurement: View Foley catheter / Ask the patient.;Incidence of dysuria. Timepoint: Within a week after the intervention. Method of measurement: Ask the patient.;Incidence of UTI. Timepoint: Within a week after the intervention. Method of measurement: Urine culture.;Incidence of urinary retention and need for CIC. Timepoint: Within a week after the intervention. Method of measurement: Ultrasonography and ask the patient.