Modified Extension Study to the SUmiT Trial: Evaluation of Long Term Therapy With Percutaneous Tibial Nerve Stimulation (PTNS) for Overactive Bladder Symptoms (STEP)

April 4, 2013 updated by: Uroplasty, Inc

Sustained Therapeutic Effects of Percutaneous Tibial Nerve Stimulation

This is a modified extension study to the SUmiT protocol UPC082008 (NCT00534521) to observe and evaluate long term therapy with PTNS on overactive bladder symptoms. Subjects must have completed the 12 weekly treatments of the original protocol, the 13 week follow up assessment, be randomized to the PTNS arm, and be considered a positive responder with moderate or marked improvement in the SUmiT Trial to be enrolled in this study. All consenting responders will continue with active PTNS therapy at an initially prescribed protocol for approximately 3 months followed by individualized symptom-based frequency of visits as determined by the subject along with their treating clinician, for up to a total of 33 months post initial 12-week therapy for a total of 3 years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Chico, California, United States, 95928
        • Gregory L. Davis, M.D., FACOG, Inc.
    • Connecticut
      • Greenwich, Connecticut, United States, 06830
        • Greenwich Urological Associates, P.C.
    • Florida
      • Naples, Florida, United States, 34102
        • Specialists in Urology
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Grand Rapids Women's Health DBA Female Pelvic Medicine & Urogynecology Institue of Michigan
      • Muskegon, Michigan, United States, 49444
        • Mercy Health Partners at the Lakes
      • Royal Oak, Michigan, United States, 48073
        • Beaumont Hospital
    • Nebraska
      • Fremont, Nebraska, United States, 68025
        • Urology Health Center, PC
    • New York
      • Albany, New York, United States, 12208
        • Capital Region Urological Surgeons, PLLC
      • White Plains, New York, United States, 10604
        • Central Missouri Women's Healthcare, LLC
    • North Carolina
      • Greensboro, North Carolina, United States, 27403
        • Alliance Urology Specialists
    • Virginia
      • Richmond, Virginia, United States, 23235
        • Virginia Urology
    • Washington
      • Issaquah, Washington, United States, 98027
        • Athena Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects who signed the informed consent and were eligible to participate in the original SUmiT Trial
  • Subjects who were randomized and treated with the active PTNS therapy during their participation in the original SUmiT Trial
  • Subject must be a positive responder from initial 12 weekly treatments as prescribed in original SUmiT Trial - 13 week GRA questionnaire must indicate "moderately" or "markedly improved" on question #1 of GRA
  • Subjects must not have started any antimuscarinics treatment since completion of original SUmiT Trial
  • Subjects must not have started any urologic Botox treatment since completion of original SUmiT Trial
  • Subjects must remain off all antimuscarinics throughout participation in trial
  • Subjects must initiate PTNS maintenance therapy within 2 weeks of their last PTNS treatment as part of SUmiT protocol UPC082008
  • Capable of giving informed consent
  • Capable and willing to follow all study-related procedures for up to 33 months for a total participation of 3 years

Exclusion Criteria:

  • Pregnant as confirmed by urine pregnancy test, or plans to become pregnant during the study period
  • Subjects who were not able or willing to follow original SUmiT Trial study schedule

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Urgent PC
The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
Device: Urgent PC
The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Patients Reporting "Moderately" or "Markedly" Improved on the Global Response Assessment (GRA) at 36 Months as Compared to Baseline
Time Frame: 36 months total
The GRA asked patients, "Compared to the last time you completed this questionnaire, how would you rate your bladder symptoms now?" and was a 7-level Assessment (markedly improved, moderately improved, slightly improved, no change, slightly worse, moderately worse, markedly worse).
36 months total

Secondary Outcome Measures

Outcome Measure
Time Frame
GRA Subset of Individual Bladder Symptom Components to Include Urgency, Frequency and Urge Incontinence.
Time Frame: every three months for 36 months
every three months for 36 months
Change in OAB-q and SF-36 Questionnaires.
Time Frame: every three months for 36 months
every three months for 36 months
Change in Voiding Diary Parameters.
Time Frame: every three months for 36 months
every three months for 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uroplasty, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

June 24, 2009

First Submitted That Met QC Criteria

June 25, 2009

First Posted (ESTIMATE)

June 26, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

May 16, 2013

Last Update Submitted That Met QC Criteria

April 4, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPC121908

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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