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

Primary Purpose

Urinary Urgency, Urinary Frequency, Nocturia

Status
Completed
Phase
Phase 2
Locations
Philippines
Study Type
Interventional
Intervention
Gabapentin
Solifenacin Succinate
Placebo drugs
Sponsored by
Michael E. Chua
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Gabapentin

Solifenacin Succinate

Placebo

Arm Description

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

Outcomes

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

Full Information

First Posted
December 4, 2011
Last Updated
December 29, 2016
Sponsor
Michael E. Chua
Collaborators
St. Luke's Medical Center, Philippines
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1. Study Identification

Unique Protocol Identification Number
NCT01486706
Brief Title
Efficacy and Safety of Gabapentin in Treating Overactive Bladder
Acronym
OAB
Official Title
Efficacy and Safety of Gabapentin in Treating Overactive Bladder
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael E. Chua
Collaborators
St. Luke's Medical Center, Philippines

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Urgency, Urinary Frequency, Nocturia, Incontinence, Detrusor Uninhibited Activity, Quality of Life
Keywords
Overactive Bladder, Gabapentin, Quality of Life, Urodynamic, safety, Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gabapentin
Arm Type
Experimental
Arm Description
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
Arm Title
Solifenacin Succinate
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Two to three months of behavioral therapy prior to Placebo form of Gabapentin and Solifenacin and titrate accordingly same as the treatment arms
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
100mg/capsule initially one capsule once a day then titrate according to the symptoms of the patient upto maximum dose of 1500mg/day
Intervention Type
Drug
Intervention Name(s)
Solifenacin Succinate
Intervention Description
5mg/tablet initially 1 tablet once a day then titrate up to maximum dose of 10mg/tab
Intervention Type
Drug
Intervention Name(s)
Placebo drugs
Intervention Description
will titrate medications similar to the active drug group
Primary Outcome Measure Information:
Title
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.
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Improvement of bladder function domain means increased bladder capacity (MVV)
Time Frame
12 weeks
Title
Improvement in quality of life domain means increased overall quality of life as perceived and result in OAB-q
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelino L Morales JR, MD
Organizational Affiliation
Institute of Urology, St. Luke's Medical Center, Philippines
Official's Role
Study Director
Facility Information:
Facility Name
Comprehensive Pelvic Floor Center- St. Luke's Medical Center
City
Quezon City
State/Province
National Capital Region
ZIP/Postal Code
1102
Country
Philippines

12. IPD Sharing Statement

Citations:
PubMed Identifier
28150436
Citation
Chua ME, See MC 4th, Esmena EB, Balingit JC, Morales ML Jr. Efficacy and Safety of Gabapentin in Comparison to Solifenacin Succinate in Adult Overactive Bladder Treatment. Low Urin Tract Symptoms. 2018 May;10(2):135-142. doi: 10.1111/luts.12152. Epub 2017 Feb 2.
Results Reference
derived

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Efficacy and Safety of Gabapentin in Treating Overactive Bladder

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