Comparison of efficacy of Bethanechol and Tamsulosin as compared to placebo in improving detrusor pressure in patients with underactive bladder
Phase 1
- Conditions
- Health Condition 1: N319- Neuromuscular dysfunction of bladder, unspecified
- Registration Number
- CTRI/2019/05/019280
- Lead Sponsor
- unsponsored
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Age above 18 years
2. Urodynamic findings
Male: BCI < 100, Qmax < 12 ml/sec
3. Patients should not already be taking any of the drugs under evaluation in the study ,
either alone or in combination
Exclusion Criteria
1. Those who are not consenting to be a part of the study
2. Patients with complete spinal cord injury / lesions
3. Those with cardiac, cerebrovascular, hepatic impairment
4. Patients already on medications likely to interfere with the drugs under evaluation, i.e
anticholinergics, alpha antagonists.
5. Patients with a known cause for bladder outlet obstruction such as stricture urethra,
urethral polyp etc (except BPH)
6. Those patients in whom use of alpha blockers and cholinergics is contraindicated
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method assessing the change in detrusor pressure measured by pressure flow study by alpha blocker, bethanechol and placebo in male patients with detrusor underactivityTimepoint: After 1 month of treatment
- Secondary Outcome Measures
Name Time Method To compare the efficacy between alpha blocker ,bethanechol and placebo treatment groups in improving IPSS score in patients with detrusor underactivity <br/ ><br>To assess the improvement in uroflometry and post void residual volume brought by use of above mentioned treatment groups in patients of detrusor underactivity. <br/ ><br>Timepoint: 1 month;To compare the efficacy between alpha blocker ,bethanechol and placebo treatment groups in improving IPSS score in patients with detrusor underactivity <br/ ><br>To assess the improvement in uroflometry and post void residual volume brought by use of above mentioned treatment groups in patients of detrusor underactivity. <br/ ><br>Timepoint: 1 month