Efficacy and Safety of Gabapentin in Treating Overactive Bladder

NCT01486706 | Completed Phase 2 DMC

• 1 other identifier: SLMC10-010
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Urgency; Urinary Frequency; Nocturia; Incontinence; Detrusor Uninhibited Activity; Quality of Life

Keywords

Overactive Bladder; Gabapentin; Quality of Life; Urodynamic; safety; Efficacy

Outcome Measures

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.

  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

Secondary Outcomes (2)

• Improvement of bladder function domain means increased bladder capacity (MVV)

  12 weeks

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

  12 weeks

Study Arms (3)

Gabapentin

EXPERIMENTAL

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

Drug: Gabapentin

Solifenacin Succinate

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

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

Gabapentin

Solifenacin Succinate DRUG

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

Solifenacin Succinate

Placebo drugs DRUG

will titrate medications similar to the active drug group

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Michael E. Chua: lead
• St. Luke's Medical Center, Philippines: collaborator

Study Sites (1)

Comprehensive Pelvic Floor Center- St. Luke's Medical Center

Quezon City, National Capital Region, 1102, Philippines

Location

Related Publications (1)

• 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.

  PMID: 28150436 DERIVED

MeSH Terms

Conditions

Nocturia; Urinary Bladder, Overactive

Interventions

Gabapentin; Solifenacin Succinate

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Marcelino L Morales JR, MD

  Institute of Urology, St. Luke's Medical Center, Philippines

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: December 4, 2011
• First Posted: December 6, 2011
• Study Start: October 1, 2010
• Primary Completion: October 1, 2014
• Study Completion: January 1, 2015
• Last Updated: January 2, 2017

Record last verified: 2016-12

Locations

PH (1)