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Comparison of efficacy of Bethanechol and Tamsulosin as compared to placebo in improving detrusor pressure in patients with underactive bladder

Comparison of efficacy of Bethanechol and Tamsulosin in detrusor underactivity: a placebo controlled double blind randomized control trial

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/05/019280
Enrollment
75
Registered
2019-05-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N319- Neuromuscular dysfunction of bladder, unspecified

Interventions

Intervention1: Treatment with bethanechol or alpha blocker or placebo: Patients meeting the inclusion criteria will be given either bethanechol or alpha blocker or placebo for 1 month duration after d

Sponsors

unsponsored
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
To compare the efficacy between alpha blocker ,bethanechol and placebo treatment groups in improving IPSS score in patients with detrusor underactivity To assess the improvement in uroflometry and post void residual volume brought by use of above mentioned treatment groups in patients of detrusor underactivity. Timepoint: 1 month;To compare the efficacy between alpha blocker ,bethanechol and placebo treatment groups in improving IPSS score in patients with detrusor underactivity To assess the improvement in uroflometry and post void residual volume brought by use of above mentioned treatment groups in patients of detrusor underactivity. Timepoint: 1 month

Countries

India

Contacts

Public ContactAditya Prakash Sharma

PGIMER

aditya.p.sharma@gmail.com7087008600

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026