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

Uroplasty

Status and phase: Completed; Phase 4

Conditions: Urinary Bladder, Overactive

Treatments: Device: Urgent PC

Study type: Interventional

Funder types: Industry

Identifiers

NCT00928395

UPC121908

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Urgent PC

Active Comparator group

Description:

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).

Treatment:

Device: Urgent PC