Trial of Maintenance Therapy With Posterior Tibial Nerve Stimulation for Overactive Bladder

This study has suspended participant recruitment.
(low recruitment)
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00912314
First received: June 1, 2009
Last updated: March 19, 2010
Last verified: June 2009
  Purpose

This study has 2 parts. Part 1 is a 12-week observational study of weekly Posterior Tibial Nerve Stimulation (PTNS) treatment for women with overactive bladder. Part 2 is a randomized, controlled trial of monthly maintenance PTNS therapy versus no therapy in subjects who were successfully treated by PTNS in Part 1.

Part 1: 12-week observational study of weekly PTNS treatment.

The primary aim of Part 1 is to determine the efficacy of a 12-week course of PTNS in the treatment of overactive bladder. Secondary aims are to determine the changes in voiding frequency and quality-of-life measures after the 12-week treatment.

Part 2: Randomized, controlled study of monthly PTNS compared to no PTNS after 12-week treatment

The primary aim is to determine time-to-failure after 12 weeks of PTNS in subjects who receive maintenance therapy compared to those who do not, in order to ascertain if there is a need for maintenance therapy after 12 weeks of PTNS. The investigators' secondary aims are to compare the long-term efficacy and quality of life impact in patient receiving maintenance PTNS compared to those that do not and to determine the efficacy of rescue maintenance PTNS in subjects who have symptom recurrence in the no maintenance therapy arm.

Hypothesis: There will be no difference in time to failure between women randomized to monthly maintenance PTNS compared to no maintenance PTNS.


Condition Intervention
Overactive Bladder Syndrome
Procedure: PTNS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of Maintenance Therapy With Posterior Tibial Nerve Stimulation for Overactive Bladder

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • time-to-failure after 12 weeks of PTNS in subjects who receive maintenance therapy compared to those who do not [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • efficacy of a 12-week course of PTNS in the treatment of overactive bladder [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: February 2009
Arms Assigned Interventions
Active Comparator: Monthly Maintenance PTNS
After 12 weeks of PTNS, patients will be randomized to either the monthly PTNS arm, or the no maintenance PTNS arm.
Procedure: PTNS
Monthly PTNS after 12 weeks of weekly PTNS
No Intervention: No maintenance PTNS
After 12 weeks of PTNS, patients will either be randomized to the Monthly PTNS arm or the No maintenance PTNS arm.
Procedure: PTNS
Monthly PTNS after 12 weeks of weekly PTNS

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • Women with refractory overactive bladder syndrome referred to UCSD Women's Pelvic Medicine Center by treating physician for PTNS therapy as standard of care
  • At least 18 years old
  • 9 or more voids per 24 hours
  • PGI - S score of "moderate" or "great" bother
  • If on anticholinergic medication, they must be on stable dose of medications for at least one month
  • Able to provide informed consent and complete study measures

Exclusion Criteria:

  • Postvoid residual > 150 ml to exclude subjects with urinary retention
  • Active urinary tract infection (defer entry until resolved)
  • Urine output > 2800 ml per day
  • Diagnosis of interstitial cystitis or chronic pelvic pain
  • Diagnosis of bladder cancer
  • Currently pregnant
  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: NCT00912314

Locations
United States, California
UCSD Women's Pelvic Medicine Center
San Diego, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Charles Nager, MD UCSD
Study Director: Anna C Kirby, MD UCSD
  More Information

No publications provided

Responsible Party: Anna Kirby, UCSD Reproductive Medicine
ClinicalTrials.gov Identifier: NCT00912314     History of Changes
Other Study ID Numbers: 0818191
Study First Received: June 1, 2009
Last Updated: March 19, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
OAB
overactive bladder
ptns
posterior tibial nerve stimulation
percutaneous tibial nerve stimulation

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014