Skip to main content
OpenTrials
Completed

NCT Number: NCT01486706

Efficacy and Safety of Gabapentin in Treating Overactive Bladder

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gabapentin

Drug

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

Drug

5mg/tablet initially 1 tablet once a day then titrate up to maximum dose of 10mg/tab

Placebo drugs

Drug

will titrate medications similar to the active drug group

Primary outcomes

  1. 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

    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

Secondary outcomes

  1. Improvement of bladder function domain means increased bladder capacity (MVV)

    Time frame: 12 weeks

  2. Improvement in quality of life domain means increased overall quality of life as perceived and result in OAB-q

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Michael E. Chua

Other

Collaborators

  • St. Luke's Medical Center, Philippines

Registry information

Acronym: OAB

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Dec 6, 2011
Registry last updated
Jan 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.