Use of Percutaneous Tibial Nerve Stimulation With Solifenacin or Placebo to Treat Refractory Overactive Bladder

NCT01764893 | Terminated Phase 4 DMC

• 1 other identifier: BSU-SOL-001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The null hypothesis for this study is that the combination of solifenacin and Percutaneous Tibial Nerve Stimulation (PTNS) is not different from PTNS alone. However the investigators anticipate a 20% improvement in patients receiving combination therapy as measured by the OAB-q (Overactive Bladder questionnaire) scores.

Conditions

Overactive Bladder

Keywords

Overactive Bladder

Outcome Measures

Primary Outcomes (2)

• Overactive Bladder Questionnaire, items 1-8 only

  Change from Baseline in Overactive Bladder Questionnaire at 11 weeks.

• Overactive Bladder Questionnaire, items 1-8 only

  Change from Baseline in Overactive Bladder Questionnaire at 15 weeks.

Secondary Outcomes (5)

• 3-day micturition diary

  Change in Bladder diary from Baseline to 5 weeks.

• 3-day micturition diary

  Change in Bladder diary from Baseline to 11 weeks.

• 3-day micturition diary

  Change in Bladder diary from Baseline to 15 weeks.

• Urgency Perception Scale (questionnaire)

  Changes in Urgency Perception from Baseline to 11 weeks.

• Urgency Perception Scale (questionnaire)

  Changes in Urgency Perception from Baseline to 15 weeks.

Study Arms (2)

PTNS and solifenacin

ACTIVE COMPARATOR

PTNS bladder neuromodulation weekly for 12 treatments; solifenacin 5 mg capsule daily for 15 weeks

Other: PTNS plus solifenacin

PTNS and placebo

PLACEBO COMPARATOR

PTNS bladder neuromodulation weekly for 12 treatments; placebo 1 capsule daily for 15 weeks

Other: Placebo

Interventions

PTNS plus solifenacin OTHER

12 weekly treatments with percutaneous tibial nerve stimulation with 5 mg of solifenacin; an additional 4 weeks of solifenacin for a total of 15 weeks of study drug.

Also known as: Vesicare

PTNS and solifenacin

Placebo OTHER

12 weekly treatments with percutaneous tibial nerve stimulation with placebo; an additional 4 weeks of placebo for a total of 15 weeks of placebo.

PTNS and placebo

Eligibility Criteria

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

You may qualify if:

• years of age or older
• history of overactive bladder
• history of inadequate response to prior or current treatment with anti- muscarinic medication, or unacceptable side effects from higher dose of anti-muscarinic medication
• PTNS-naive
• willing to discontinue the use of anti-muscarinic agents for 2 weeks before start of study medication ("washing out")
• able to swallow and retain oral medication
• able and willing to participate in the full duration of the study
• able to read and write (health outcomes questionnaires are self-administered)and understand instructions related to study procedures and give written informed consent
• OAB-q (items 1-8) score of 30 or higher

You may not qualify if:

• presence of cardiac pacemaker and/or defibrillator
• history of urinary retention
• history of gastric retention
• uncontrolled narrow angle glaucoma
• any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction,coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 3 months prior to Screening visit
• abnormal liver function test (greater than 3 times the upper limit of normal for alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], or alkaline phosphatase \[ALP\]); or bilirubin \> 3 times the upper limit of normal
• history of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject
• known hypersensitivity to solifenacin
• participation in any investigational or marketed drug trial within the 30 days prior to the first dose of study drug or any time during the study period
• pregnancy or trying to become pregnant
• breast-feeding

Sponsors & Collaborators

• Bay State Clinical Trials, Inc.: lead

Study Sites (1)

Bay State Clinical Trials, Inc.

Watertown, Massachusetts, 02472, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Solifenacin Succinate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• H. David Mitcheson, MD

  Bay State Clinical Trials, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2013
• First Posted: January 10, 2013
• Study Start: January 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 23, 2014

Record last verified: 2014-05

Locations

US (1)