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

Primary Purpose

Overactive Bladder

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

PTNS plus solifenacin

Placebo

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive Bladder

Eligibility Criteria

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

Inclusion Criteria:

18 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

Exclusion Criteria:

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

Sites / Locations

Bay State Clinical Trials, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

PTNS and solifenacin

PTNS and placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overactive Bladder Questionnaire, items 1-8 only

Secondary Outcome Measures

3-day micturition diary

To measure changes in frequency, urgency, urge incontinence episodes, nocturia and urine volume (one day of each 3-day diary)

3-day micturition diary

To measure changes in frequency, urgency, urge incontinence episodes, nocturia and urine volume (one day of each 3-day diary)

3-day micturition diary

To measure changes in frequency, urgency, urge incontinence episodes, nocturia and urine volume (one day of each 3-day diary)

Urgency Perception Scale (questionnaire)

Full Information

NCT ID

NCT01764893

First Posted

January 3, 2013

Last Updated

May 22, 2014

Sponsor

Bay State Clinical Trials, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01764893

Brief Title

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

Official Title

A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy of Solifenacin and Percutaneous Tibial Nerve Stimulation in Patients With Refractory Overactive Bladder

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Terminated

Why Stopped

Enrolling too slowly due to insurance plans no longer covering the cost of the Percutaneous Tibial Nerve Stimulation treatment.

Study Start Date

January 2013 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bay State Clinical Trials, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overactive Bladder

Keywords

Overactive Bladder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PTNS and solifenacin

Arm Type

Active Comparator

Arm Description

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

Arm Title

PTNS and placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

PTNS plus solifenacin

Other Intervention Name(s)

Vesicare

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Overactive Bladder Questionnaire, items 1-8 only

Time Frame

Change from Baseline in Overactive Bladder Questionnaire at 11 weeks.

Title

Overactive Bladder Questionnaire, items 1-8 only

Time Frame

Change from Baseline in Overactive Bladder Questionnaire at 15 weeks.

Secondary Outcome Measure Information:

Title

3-day micturition diary

Description

To measure changes in frequency, urgency, urge incontinence episodes, nocturia and urine volume (one day of each 3-day diary)

Time Frame

Change in Bladder diary from Baseline to 5 weeks.

Title

3-day micturition diary

Description

To measure changes in frequency, urgency, urge incontinence episodes, nocturia and urine volume (one day of each 3-day diary)

Time Frame

Change in Bladder diary from Baseline to 11 weeks.

Title

3-day micturition diary

Description

To measure changes in frequency, urgency, urge incontinence episodes, nocturia and urine volume (one day of each 3-day diary)

Time Frame

Change in Bladder diary from Baseline to 15 weeks.

Title

Urgency Perception Scale (questionnaire)

Time Frame

Changes in Urgency Perception from Baseline to 11 weeks.

Title

Urgency Perception Scale (questionnaire)

Time Frame

Changes in Urgency Perception from Baseline to 15 weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

H. David Mitcheson, MD

Organizational Affiliation

Bay State Clinical Trials, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bay State Clinical Trials, Inc.

City

Watertown

State/Province

Massachusetts

ZIP/Postal Code

02472

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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