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

NCT ID: NCT00928395

Last Updated: 2013-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2012-12-31

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.

Conditions

Urinary Bladder, Overactive

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Urgent PC

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uroplasty, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth Peters, MD

Role: PRINCIPAL_INVESTIGATOR

Beaumont Hospital

Locations

Gregory L. Davis, M.D., FACOG, Inc.

Chico, California, United States

Greenwich Urological Associates, P.C.

Greenwich, Connecticut, United States

Specialists in Urology

Naples, Florida, United States

Grand Rapids Women's Health DBA Female Pelvic Medicine & Urogynecology Institue of Michigan

Grand Rapids, Michigan, United States

Mercy Health Partners at the Lakes

Muskegon, Michigan, United States

Beaumont Hospital

Royal Oak, Michigan, United States

Urology Health Center, PC

Fremont, Nebraska, United States

Capital Region Urological Surgeons, PLLC

Albany, New York, United States

Central Missouri Women's Healthcare, LLC

White Plains, New York, United States

Alliance Urology Specialists

Greensboro, North Carolina, United States

Virginia Urology

Richmond, Virginia, United States

Athena Urology

Issaquah, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 22674493 (View on PubMed)

Other Identifiers

UPC121908

Identifier Type: -

Identifier Source: org_study_id