Efficacy and Safety of Gabapentin in Treating Overactive Bladder (OAB)
Urinary Urgency, Urinary Frequency, Nocturia
About this trial
This is an interventional treatment trial for Urinary Urgency focused on measuring Overactive Bladder, Gabapentin, Quality of Life, Urodynamic, safety, Efficacy
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Comprehensive Pelvic Floor Center- St. Luke's Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Placebo Comparator
Gabapentin
Solifenacin Succinate
Placebo
Two to three months of behavioral therapy prior to start of Gabapentin 100mg/capsule, initially 1 capsule once a day for 1 week then titrate dosage according to symptoms until maximum dose of 1500mg/day Placebo tablet of Solifenacin Succinate will titrate dose same as Solifenacin arm according to symptoms of patient
Two to three months of behavioral therapy prior to Solifenacin Succinate 5mg/tablet initially 1 tablet once a day then titrate dosage according to symptoms upto maximum dose of 10mg/day Placebo form of Gabapentin will titrate dosage same as Gabapentin group according to symptoms of patient
Two to three months of behavioral therapy prior to Placebo form of Gabapentin and Solifenacin and titrate accordingly same as the treatment arms