Efficacy and Safety of Gabapentin in Treating Overactive Bladder
Overview[ - collapse ][ - ]
| Purpose | Overactive bladder (OAB) syndrome as defined by International Continence Society is a pathological condition characterized by irritative symptoms: urinary urgency, with or without incontinence, urinary frequency and nocturia. The syndrome often seriously compromises the quality of life of the patients. The etiology of the OAB is considered multifactorial. Neural plasticity of bladder afferent pathways is one of the proposed mechanisms of OAB. The detrusor muscle itself has for many years been the target for drug treatment such as antimuscarinics. However, depression of detrusor contractility, may results in a reduced ability to empty the bladder and lead to some sympathetic adverse effects, which limits the treatment of OAB. Currently the focus of OAB treatment has changed to other bladder structures/mechanisms, such as afferent nerves and urothelial signaling as targets for intervention. C-fiber bladder afferents nerves may be critical for symptom generation in pathologic states such as OAB because these fibers demonstrate remarkable plasticity. Up-regulation of bladder C-fiber afferent nerve function may also play a role in urge incontinence, overactive bladder (OAB) and sensory urgency. The mechanism of Gabapentin's action for neuropathic pain has not been fully elucidated but is appears to have inhibitory activity on afferent C-fibers nerve activity; moreover, several studies had established the safety of Gabapentin in its treatment of different conditions. Due to the proposed mechanism, the investigators suggest that Gabapentin may be a new alternative for treating OAB. |
|---|---|
| Condition | Urinary Frequency Urinary Urgency Nocturia Incontinence Detrusor Uninhibited Activity Quality of Life |
| Intervention | Drug: Gabapentin Drug: Solifenacin Succinate Drug: Placebo drugs |
| Phase | Phase 4 |
| Sponsor | St. Luke's Medical Center, Philippines |
| Responsible Party | St. Luke's Medical Center, Philippines |
| ClinicalTrials.gov Identifier | NCT01486706 |
| First Received | December 4, 2011 |
| Last Updated | August 17, 2013 |
| Last verified | August 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | December 4, 2011 |
|---|---|
| Last Updated Date | August 17, 2013 |
| Start Date | January 2012 |
| Estimated Primary Completion Date | January 2015 |
| Current Primary Outcome Measures | improvement of symptom domain means decreased frequency to less than 8 micturitions per 24 hours, no urgency noted per 24 hrs and less that 3 wakening at bedtime for micturation. [Time Frame: 12 weeks] [Designated as safety issue: Yes] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Efficacy and Safety of Gabapentin in Treating Overactive Bladder |
|---|---|
| Official Title | A Prospective 12-Week, Randomized, Double-Blind, Double Dummy Placebo-Controlled, Parallel-Group, Clinical Trial to Evaluate The Efficacy And Safety Of Gabapentin In Comparison to Solifenacin Succinate in Patients With Overactive Bladder |
| 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, urinary frequency and nocturia. The syndrome often seriously compromises the quality of life of the patients. The etiology of the OAB is considered multifactorial. Neural plasticity of bladder afferent pathways is one of the proposed mechanisms of OAB. The detrusor muscle itself has for many years been the target for drug treatment such as antimuscarinics. However, depression of detrusor contractility, may results in a reduced ability to empty the bladder and lead to some sympathetic adverse effects, which limits the treatment of OAB. Currently the focus of OAB treatment has changed to other bladder structures/mechanisms, such as afferent nerves and urothelial signaling as targets for intervention. C-fiber bladder afferents nerves may be critical for symptom generation in pathologic states such as OAB because these fibers demonstrate remarkable plasticity. Up-regulation of bladder C-fiber afferent nerve function may also play a role in urge incontinence, overactive bladder (OAB) and sensory urgency. The mechanism of Gabapentin's action for neuropathic pain has not been fully elucidated but is appears to have inhibitory activity on afferent C-fibers nerve activity; moreover, several studies had established the safety of Gabapentin in its treatment of different conditions. Due to the proposed mechanism, the investigators suggest that Gabapentin may be a new alternative for treating OAB. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition |
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| Intervention | Drug: Gabapentin 100mg/capsule initially one capsule once a day then 1 capsule 2x/day then titrate according to the symptoms of the patient upto maximum dose of 900mg/day Drug: Solifenacin Succinate 5mg/tablet initially 1 tablet once a day then titrate up to maximum dose of 10mg/tab Drug: Placebo drugs will titrate medications similar to the active drug group |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 120 |
| Estimated Completion Date | January 2015 |
| Estimated Primary Completion Date | November 2014 |
| 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 - 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 - Patient has multiple and/or severe allergies to foods and drugs - Patient regularly uses any illegal drugs |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Micheal E. Chua, MD 6327230101 auhc_ekim@yahoo.com |
| Location Countries | Philippines |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01486706 |
|---|---|
| Other Study ID Numbers | SLMC10-010 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | St. Luke's Medical Center, Philippines |
| Study Sponsor | St. Luke's Medical Center, Philippines |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Michael E. Chua, MD Institute of Urology, St. Luke's Medical Center, Philippines |
| Verification Date | August 2013 |
Locations[ + expand ][ + ]
| Comprehensive Pelvic Floor Center- St. Luke's Medical Center | Quezon City, National Capital Region, Philippines, 1102 Contact: Michael E. Chua, MD | 63272301015425 | auhc_ekim@yahoo.comPrincipal Investigator: Michael E. Chua, MD Not yet recruiting |
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| Comprehensive pelvic floor center- St. Luke's Medical Center | Quezon City, NCR, Philippines, 1102 Contact: Michael E. Chua, MD | 639178401027 | auhc_ekim@yahoo.comRecruiting |