Trigonal vs Non Trigonal Botox Injection in OAB.
NCT03533062 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2018-10-09
Summary
The investigators attend to conduct a prospective randomized study to assess safety and efficacy of trigonal-involved vs. trigonal-sparing botox injection technique, quality of life measurement and post-injection anticholinergics use efficacy.
Assessing safety by identification of side effects like constipation, urine retention....etc.
efficacy is measured using Over Active Bladder Symptoms Score(OABSS) and urodynamics measures after 6 months follow up.
Conditions
- Urologic Diseases
- Overactive Bladder Syndrome
- Quality of Life
- Anticholinergic Syndrome
Interventions
- DRUG
-
botulinum toxin A
botox A injection trigonal or trigonal sparing with trial of anticholinergics 6 months post operative for 3 months
Sponsors & Collaborators
-
Mansoura University
lead OTHER
Principal Investigators
-
Ahmed Shoma, MD · Urology and Nephrology Cente. Mansourah, Aldakahlia, Egypt, 35516
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-06-14
- Primary Completion
- 2016-10-30
- Completion
- 2018-05-30
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