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

Overactive Bladder Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01764893
• Other study ID #: BSU-SOL-001
• Status: Terminated
• Phase: Phase 4
• First received: January 3, 2013
• Last updated: May 22, 2014
• Start date: January 2013
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: Bay State Clinical Trials, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18 years of age or older

2. history of overactive bladder

3. history of inadequate response to prior or current treatment with anti- muscarinic medication, or unacceptable side effects from higher dose of anti-muscarinic medication

4. PTNS-naive

5. willing to discontinue the use of anti-muscarinic agents for 2 weeks before start of study medication ("washing out")

6. able to swallow and retain oral medication

7. able and willing to participate in the full duration of the study

8. able to read and write (health outcomes questionnaires are self-administered)and understand instructions related to study procedures and give written informed consent

9. OAB-q (items 1-8) score of 30 or higher

Exclusion Criteria:

1. presence of cardiac pacemaker and/or defibrillator

2. history of urinary retention

3. history of gastric retention

4. uncontrolled narrow angle glaucoma

5. 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

6. 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

7. 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

8. known hypersensitivity to solifenacin

9. 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

10. pregnancy or trying to become pregnant

11. breast-feeding

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Other:
• PTNS plus solifenacin
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.
• Placebo
12 weekly treatments with percutaneous tibial nerve stimulation with placebo; an additional 4 weeks of placebo for a total of 15 weeks of placebo.

Locations

Country	Name	City	State
United States	Bay State Clinical Trials, Inc.	Watertown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Bay State Clinical Trials, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overactive Bladder Questionnaire, items 1-8 only		Change from Baseline in Overactive Bladder Questionnaire at 11 weeks.
Primary	Overactive Bladder Questionnaire, items 1-8 only		Change from Baseline in Overactive Bladder Questionnaire at 15 weeks.
Secondary	3-day micturition diary	To measure changes in frequency, urgency, urge incontinence episodes, nocturia and urine volume (one day of each 3-day diary)	Change in Bladder diary from Baseline to 5 weeks.
Secondary	3-day micturition diary	To measure changes in frequency, urgency, urge incontinence episodes, nocturia and urine volume (one day of each 3-day diary)	Change in Bladder diary from Baseline to 11 weeks.
Secondary	3-day micturition diary	To measure changes in frequency, urgency, urge incontinence episodes, nocturia and urine volume (one day of each 3-day diary)	Change in Bladder diary from Baseline to 15 weeks.
Secondary	Urgency Perception Scale (questionnaire)		Changes in Urgency Perception from Baseline to 11 weeks.
Secondary	Urgency Perception Scale (questionnaire)		Changes in Urgency Perception from Baseline to 15 weeks.