Effectiveness of Bethanechol chloride in bladder disorders patients.

Not Applicable

• Conditions: Health Condition 1: N328- Other specified disorders of bladder

• Registration Number: CTRI/2023/05/052672
• Lead Sponsor: Ranchi Urology Center (RUC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Male and female patients above 18 years at the time of signing the informed consent

2. Subject diagnosed with underactive bladder (UAB)

3. Patients with underactive bladder (UAB) meeting the below criteria for impaired detrusor contractility and no obstruction based on

uroflowmetry and urodynamic study (Pressure - Flow study):

a. IPSS

b. QOL

c. Qmax

d. PVR

e. The Bladder Contractility Index

f. The Bladder Outlet Obstruction Index (BOOI)

4. Patients with controlled hypertension and type 2 diabetes mellitus will also be considered for the study

Exclusion Criteria

1. Impaired detrusor contractility due to causes like complete spinal cord lesions, post-operative, and post pregnancy

2. With bladder outlet obstruction as determined by a urodynamic study, including a pressure/flow study

3. With detrusor-external sphincter dyssynergia determined by a urodynamic study and with external sphincter electromyography

4. On medication with anticholinergics, other alfa-antagonists, or beta-agonists or antagonists

5. Patients with compromised liver and renal function

6. Patients in whom bethanechol is contraindicated as per the prescribing information

7. Patients with diabetic neuropathy, glaucoma, abdominal cramps, and inflammation will not be included in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in mean PVR (Post-Void Residual urine volume) at the end of 12 weeks treatmentTimepoint: Screening (Baseline), 4 weeks, 8 weeks and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in mean IPSS (International Prostate Symptom Score) at the <br/ ><br>end of 12 weeks treatmentTimepoint: Screening (Baseline), 12 weeks;Change from baseline in mean IPSS at the end of 4 weeks and 8 weeks treatmentTimepoint: Screening (Baseline), 4 weeks, 8 weeks;Change from baseline in mean PVR at the end of 4 weeks and 8 weeks treatmentTimepoint: Screening (Baseline), 4 weeks, 8 weeks