Comparing the efficacy of Mirabegron in reducing urinary symptoms associated with Parkinsons disease
Phase 4
- Conditions
- Health Condition 1: G20- Parkinsons disease
- Registration Number
- CTRI/2023/01/048770
- Lead Sponsor
- DEPARTMENT OF UROLOGY KASTURBA MEDICAL COLLEGE MANIPA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All patients with Parkinson disease having moderate/bothersome LUTS as per IPSS questionnaire
Exclusion Criteria
1. Montreal Cognitive Assessment score <24,
2. Poorly controlled diabetes or poorly controlled hypertension ,
3. Indwelling catheter,
4. Renal dialysis
5. Cardiac failure requiring diuretics
6. Urinary tract infection at presentation
7. Prostate or bladder cancer
8. Uncontrolled bladder outlet obstruction
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome measures: Change in the objectively measurable parameters namely: 1. Change in day time urinary frequency 2. Change in number of nocturia episodes 3. Change in functional bladder capacity 4. Change in QmaxTimepoint: 4 weeks
- Secondary Outcome Measures
Name Time Method Change in the <br/ ><br>1. IPSS score <br/ ><br>2. OABSS (Over Active Bladder Symptom Score) <br/ ><br>3. OAB-q SF Score <br/ ><br>4. Patient Perception of Bladder Condition (PPBC) <br/ ><br>5. OAB family impact measure (OAB-FIM) scoreTimepoint: 4 WEEKS, 8 WEEKS AND 12 WEEKS