Status:
COMPLETED
Efficacy and Safety of Gabapentin in Treating Overactive Bladder
Lead Sponsor:
Michael E. Chua
Collaborating Sponsors:
St. Luke's Medical Center, Philippines
Conditions:
Urinary Urgency
Urinary Frequency
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
Overactive bladder (OAB) syndrome as defined by International Continence Society is a pathological condition characterized by irritative symptoms: urinary urgency, with or without incontinence, urinar...
Eligibility Criteria
Inclusion
- Ambulatory and able to use the toilet without difficulty
- History of OAB symptoms for ≥ 3 months
- An average of ≥ 8 micturitions per 24 hours and ≥ 1 urgency episode (with or without incontinence) per 24 hours as documented in a 3-day micturition diary
- Subjects are bothered by symptoms as reflected by OAB-questionnaire
Exclusion
- Patient has stress or mixed incontinence
- Patient has Benign Prostatic Hyperplasia with severe lower urinary tract symptoms based on IPSS score
- Patient has uncontrolled Diabetes Mellitus Type II Patient has Diabetes Insipidus, UTI
- Patient has history of interstitial cystitis, painful bladder syndrome, or chronic pelvic pain
- Patient has a history of stroke, seizures, or major neurological disorders
- Patient has a history of fecal incontinence and or continual urine leakage
- Patient has had surgery to correct stress urinary incontinence or pelvic organ prolapse within 6 months of study start
- Patient received bladder training of electrostimulation within 2 weeks of study start
- Patient requires a catheter
- Patient is taking medications that cannot be stopped for the duration of the trial including certain anticholinergics or smooth muscle relaxants
- Patient began taking tricyclic antidepressants, serotonin/norepinephrine reuptake inhibitors, calcium channel blockers, ephedrine/pseudoephedrine, or diuretic therapy less than 8 weeks before study start
- Patient has been on hormone replacement therapy for less than 12 weeks at study start
- Patient must take medication for arrhythmia, contraindicated for Solifenacin or Gabapentin
- Patient has multiple and/or severe allergies to foods and drugs
- Patient regularly uses any illegal drugs
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT01486706
Start Date
October 1 2010
End Date
January 1 2015
Last Update
January 2 2017
Active Locations (1)
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1
Comprehensive Pelvic Floor Center- St. Luke's Medical Center
Quezon City, National Capital Region, Philippines, 1102