Efficacy and Safety of Gabapentin in Treating Overactive Bladder

Quality of Life Clinical Trial

— OAB  

Official title:

Efficacy and Safety of Gabapentin in Treating Overactive Bladder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01486706
• Other study ID #: SLMC10-010
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 4, 2011
• Last updated: December 29, 2016
• Start date: October 2010
• Est. completion date: January 2015

Study information

• Verified date: December 2016
• Source: St. Luke's Medical Center, Philippines
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: January 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Detrusor Uninhibited Activity
• Incontinence
• Nocturia
• Quality of Life
• Urinary Bladder, Overactive
• Urinary Frequency
• Urinary Urgency

Intervention

Drug:
• Gabapentin
100mg/capsule initially one capsule once a day then titrate according to the symptoms of the patient upto maximum dose of 1500mg/day
• Solifenacin Succinate
5mg/tablet initially 1 tablet once a day then titrate up to maximum dose of 10mg/tab
• Placebo drugs
will titrate medications similar to the active drug group

Locations

Country	Name	City	State
Philippines	Comprehensive Pelvic Floor Center- St. Luke's Medical Center	Quezon City	National Capital Region

Sponsors (2)

Lead Sponsor	Collaborator
Michael E. Chua	St. Luke's Medical Center, Philippines

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Mean number of Micturations per 24 hrs, Mean number of urgency episodes pe 24 hrs, mean urgency incontinence episodes per 24hrs and mean nocturia episodes per 24hrs	12 weeks	Yes
Secondary	Improvement of bladder function domain means increased bladder capacity (MVV)		12 weeks	Yes
Secondary	Improvement in quality of life domain means increased overall quality of life as perceived and result in OAB-q		12 weeks	Yes