Health Condition 1: null- Benign prostatic hyperplasia with overactive bladder symptoms
Conditions
Interventions
Intervention1: Tamsulosin 0.4 mg and Solifenacin 5 mg: Patients who fulfill the inclusion criteria will be randomised to receive Tamsulosin 0.4 mg OD orally or Tamsulosin 0.4 mg and Solifenacin 5 mg O
Sponsors
Cipla Limited
Eligibility
Inclusion criteria
Inclusion criteria: Lower Urinary Tract Symptoms for more than 3 months, that are Attributable to Benign Prostatic Hyperplasia (BPH), as confirmed with International Prostate Symptom Score of greater than 8, and who have Maximum urine flow rate of less than 12 ml/second, with voided volume more than 120 ml and Post-void residue measured by Ultrasound (USG) of less than 120 ml, Overactive bladder symptoms of more than 8 voids in 24 hours, more than 2 voids at night, and more than 1 episode of urgency in 24 hours
Exclusion criteria
Exclusion criteria: History of Urinary retention in preceding 12 months, or Treatment of BPH with alpha-receptor antagonists, plant extracts, and or 5-alpha-reductase inhibitors, or Other causes of LUTS e.g., urethral stricture, or Neurogenic bladder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline to end-of-treatment in patient reported symptoms of Total IPSS scores Total Urgency and Frequency Scores Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline to end-of-treatment in patient reported symptoms of Storage subscore of IPSS Voiding subscore of IPSS Voiding episodes in 24 hours Nocturnal voids in 24 hours Urgency episodes in 24 hours Timepoint: After 12 weeks | — |
Countries
India
Contacts
Public ContactOmar Salim Akhtar
Grant Govt Medical College & Sir J J Associated Hospitals
Outcome results
None listed