Modified Extension Study to the SUmiT Trial: Evaluation of Long Term Therapy With Percutaneous Tibial Nerve Stimulation (PTNS) for Overactive Bladder Symptoms
STEP
Sustained Therapeutic Effects of Percutaneous Tibial Nerve Stimulation
1 other identifier
interventional
50
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2009
Longer than P75 for phase_4
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 24, 2009
CompletedFirst Posted
Study publicly available on registry
June 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
May 16, 2013
CompletedMay 16, 2013
April 1, 2013
3.7 years
June 24, 2009
January 24, 2013
April 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Patients Reporting "Moderately" or "Markedly" Improved on the Global Response Assessment (GRA) at 36 Months as Compared to Baseline
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 Outcomes (3)
GRA Subset of Individual Bladder Symptom Components to Include Urgency, Frequency and Urge Incontinence.
every three months for 36 months
Change in OAB-q and SF-36 Questionnaires.
every three months for 36 months
Change in Voiding Diary Parameters.
every three months for 36 months
Study Arms (1)
Urgent PC
ACTIVE COMPARATORThe 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).
Interventions
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uroplasty, Inclead
Study Sites (12)
Gregory L. Davis, M.D., FACOG, Inc.
Chico, California, 95928, United States
Greenwich Urological Associates, P.C.
Greenwich, Connecticut, 06830, United States
Specialists in Urology
Naples, Florida, 34102, United States
Grand Rapids Women's Health DBA Female Pelvic Medicine & Urogynecology Institue of Michigan
Grand Rapids, Michigan, 49503, United States
Mercy Health Partners at the Lakes
Muskegon, Michigan, 49444, United States
Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Urology Health Center, PC
Fremont, Nebraska, 68025, United States
Capital Region Urological Surgeons, PLLC
Albany, New York, 12208, United States
Central Missouri Women's Healthcare, LLC
White Plains, New York, 10604, United States
Alliance Urology Specialists
Greensboro, North Carolina, 27403, United States
Virginia Urology
Richmond, Virginia, 23235, United States
Athena Urology
Issaquah, Washington, 98027, United States
Related Publications (1)
Peters KM, Carrico DJ, MacDiarmid SA, Wooldridge LS, Khan AU, McCoy CE, Franco N, Bennett JB. Sustained therapeutic effects of percutaneous tibial nerve stimulation: 24-month results of the STEP study. Neurourol Urodyn. 2013 Jan;32(1):24-9. doi: 10.1002/nau.22266. Epub 2012 Jun 5.
PMID: 22674493DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Study Manager
- Organization
- Uroplasty, Inc
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth Peters, MD
Beaumont Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2009
First Posted
June 26, 2009
Study Start
January 1, 2009
Primary Completion
September 1, 2012
Study Completion
December 1, 2012
Last Updated
May 16, 2013
Results First Posted
May 16, 2013
Record last verified: 2013-04