Health Condition 1: N328- Other specified disorders of bladder
Conditions
Interventions
Intervention1: Bethanechol chloride: Patients will be administered the study medication
(75mg/150mg per day in three divided doses) for a period of 12 weeks.
Administer the drug orally with water whe
Sponsors
Ranchi Urology Center (RUC)
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Change from baseline in mean IPSS (International Prostate Symptom Score) at the 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 | — |
Countries
India
Contacts
Public ContactDr Shamim Ahmad
Ranchi Urology Center
Outcome results
None listed