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

NCT00912314 | Completed

• 1 other identifier: 0818191
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overactive Bladder Syndrome

Keywords

OAB; overactive bladder; ptns; posterior tibial nerve stimulation; percutaneous tibial nerve stimulation

Outcome Measures

Primary Outcomes (1)

• time-to-failure after 12 weeks of PTNS in subjects who receive maintenance therapy compared to those who do not

  40 weeks

Secondary Outcomes (1)

• efficacy of a 12-week course of PTNS in the treatment of overactive bladder

  12 weeks

Study Arms (2)

Monthly Maintenance PTNS

ACTIVE COMPARATOR

After 12 weeks of PTNS, patients will be randomized to either the monthly PTNS arm, or the no maintenance PTNS arm.

Procedure: PTNS

No maintenance PTNS

NO INTERVENTION

After 12 weeks of PTNS, patients will either be randomized to the Monthly PTNS arm or the No maintenance PTNS arm.

Interventions

PTNS PROCEDURE

Monthly PTNS after 12 weeks of weekly PTNS

Monthly Maintenance PTNS

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Women's Pelvic Medicine Center

San Diego, California, 92037, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

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

Study Officials

• Charles Nager, MD

  UCSD

  PRINCIPAL INVESTIGATOR

• Anna C Kirby, MD

  UCSD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2009
• First Posted: June 3, 2009
• Study Start: February 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: August 2, 2019

Record last verified: 2019-07

Locations

US (1)