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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Uroplasty, Inc
ClinicalTrials.gov Identifier:
NCT00928395
First received: June 24, 2009
Last updated: April 4, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Urinary Bladder, Overactive
Device: Urgent PC
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sustained Therapeutic Effects of Percutaneous Tibial Nerve Stimulation

Resource links provided by NLM:


Further study details as provided by Uroplasty, Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • GRA Subset of Individual Bladder Symptom Components to Include Urgency, Frequency and Urge Incontinence. [ Time Frame: every three months for 36 months ] [ Designated as safety issue: No ]
  • Change in OAB-q and SF-36 Questionnaires. [ Time Frame: every three months for 36 months ] [ Designated as safety issue: No ]
  • Change in Voiding Diary Parameters. [ Time Frame: every three months for 36 months ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: January 2009
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

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

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
  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: NCT00928395

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

No publications provided by Uroplasty, Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Uroplasty, Inc
ClinicalTrials.gov Identifier: NCT00928395     History of Changes
Other Study ID Numbers: UPC121908
Study First Received: June 24, 2009
Results First Received: January 24, 2013
Last Updated: April 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Uroplasty, Inc:
Urgent PC
Overactive Bladder
SUmiT Trial
Overactive Urinary Bladder

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

ClinicalTrials.gov processed this record on September 18, 2014