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:
Uroplasty, Inc
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
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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 |
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
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 Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013