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Efficacy and Safety of Gabapentin in Treating Overactive Bladder (OAB)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Michael E. Chua, St. Luke's Medical Center, Philippines
ClinicalTrials.gov Identifier:
NCT01486706
First received: December 4, 2011
Last updated: October 12, 2014
Last verified: October 2014
  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 Intervention Phase
Urinary Frequency
Urinary Urgency
Nocturia
Incontinence
Detrusor Uninhibited Activity
Quality of Life
Drug: Gabapentin
Drug: Solifenacin Succinate
Drug: Placebo drugs
Phase 4

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

Resource links provided by NLM:


Further study details as provided by St. Luke's Medical Center, Philippines:

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 ]
    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 Outcome Measures:
  • Improvement of bladder function domain means increased bladder capacity and decreased overactive detrusor as recorded in urodynamic study. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Improvement in quality of life domain means increased overall quality of life as perceived and result in OAB-q [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: October 2010
Estimated Study Completion Date: January 2015
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gabapentin
Two to three months of behavioral therapy prior to start of Gabapentin 100mg/capsule, initially 1 capsule once a day for one day then 2x/day 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
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 1500mg/day
Active Comparator: Solifenacin Succinate
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
Drug: Solifenacin Succinate
5mg/tablet initially 1 tablet once a day then titrate up to maximum dose of 10mg/tab
Placebo Comparator: Placebo
Two to three months of behavioral therapy prior to Placebo form of Gabapentin and Solifenacin and titrate accordingly same as the treatment arms
Drug: Placebo drugs
will titrate medications similar to the active drug group

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01486706

Locations
Philippines
Comprehensive Pelvic Floor Center- St. Luke's Medical Center
Quezon City, National Capital Region, Philippines, 1102
Comprehensive pelvic floor center- St. Luke's Medical Center
Quezon City, NCR, Philippines, 1102
Sponsors and Collaborators
St. Luke's Medical Center, Philippines
Investigators
Principal Investigator: Michael E. Chua, MD Institute of Urology, St. Luke's Medical Center, Philippines
  More Information

No publications provided

Responsible Party: Michael E. Chua, Medical Doctor, St. Luke's Medical Center, Philippines
ClinicalTrials.gov Identifier: NCT01486706     History of Changes
Other Study ID Numbers: SLMC10-010
Study First Received: December 4, 2011
Last Updated: October 12, 2014
Health Authority: Philippines: Ethics Committee

Keywords provided by St. Luke's Medical Center, Philippines:
Overactive Bladder
Gabapentin
Quality of Life
Urodynamic
safety
Efficacy

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Gabapentin
Solifenacin
Analgesics
Anti-Anxiety Agents
Anti-Dyskinesia Agents
Anticonvulsants
Antimanic Agents
Antiparkinson Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Cholinergic Agents
Cholinergic Antagonists
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs

ClinicalTrials.gov processed this record on November 20, 2014