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

This study has been terminated.
(Enrolling too slowly due to insurance plans no longer covering the cost of the Percutaneous Tibial Nerve Stimulation treatment.)
Sponsor:
Information provided by (Responsible Party):
Bay State Clinical Trials, Inc.
ClinicalTrials.gov Identifier:
NCT01764893
First received: January 3, 2013
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Overactive Bladder
Other: PTNS plus solifenacin
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bay State Clinical Trials, Inc.:

Primary Outcome Measures:
  • Overactive Bladder Questionnaire, items 1-8 only [ Time Frame: Change from Baseline in Overactive Bladder Questionnaire at 11 weeks. ] [ Designated as safety issue: No ]
  • Overactive Bladder Questionnaire, items 1-8 only [ Time Frame: Change from Baseline in Overactive Bladder Questionnaire at 15 weeks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 3-day micturition diary [ Time Frame: Change in Bladder diary from Baseline to 5 weeks. ] [ Designated as safety issue: No ]
    To measure changes in frequency, urgency, urge incontinence episodes, nocturia and urine volume (one day of each 3-day diary)

  • 3-day micturition diary [ Time Frame: Change in Bladder diary from Baseline to 11 weeks. ] [ Designated as safety issue: No ]
    To measure changes in frequency, urgency, urge incontinence episodes, nocturia and urine volume (one day of each 3-day diary)

  • 3-day micturition diary [ Time Frame: Change in Bladder diary from Baseline to 15 weeks. ] [ Designated as safety issue: No ]
    To measure changes in frequency, urgency, urge incontinence episodes, nocturia and urine volume (one day of each 3-day diary)

  • Urgency Perception Scale (questionnaire) [ Time Frame: Changes in Urgency Perception from Baseline to 11 weeks. ] [ Designated as safety issue: No ]
  • Urgency Perception Scale (questionnaire) [ Time Frame: Changes in Urgency Perception from Baseline to 15 weeks. ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: January 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PTNS and solifenacin
PTNS bladder neuromodulation weekly for 12 treatments; solifenacin 5 mg capsule daily for 15 weeks
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.
Other Name: Vesicare
Placebo Comparator: PTNS and placebo
PTNS bladder neuromodulation weekly for 12 treatments; placebo 1 capsule daily for 15 weeks
Other: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01764893

Locations
United States, Massachusetts
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, United States, 02472
Sponsors and Collaborators
Bay State Clinical Trials, Inc.
Investigators
Principal Investigator: H. David Mitcheson, MD Bay State Clinical Trials, Inc.
  More Information

No publications provided

Responsible Party: Bay State Clinical Trials, Inc.
ClinicalTrials.gov Identifier: NCT01764893     History of Changes
Other Study ID Numbers: BSU-SOL-001
Study First Received: January 3, 2013
Last Updated: May 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bay State Clinical Trials, Inc.:
Overactive Bladder

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014