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

Urinary Bladder, Overactive Clinical Trial

— STEP  

Official title:

Sustained Therapeutic Effects of Percutaneous Tibial Nerve Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00928395
• Other study ID #: UPC121908
• Status: Completed
• Phase: Phase 4
• First received: June 24, 2009
• Last updated: April 4, 2013
• Start date: January 2009
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: Uroplasty, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Bladder, Overactive

Intervention

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).

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Uroplasty, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	GRA Subset of Individual Bladder Symptom Components to Include Urgency, Frequency and Urge Incontinence.		every three months for 36 months	No
Secondary	Change in OAB-q and SF-36 Questionnaires.		every three months for 36 months	No
Secondary	Change in Voiding Diary Parameters.		every three months for 36 months	No