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

Study Overview
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Brief Summary
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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.

Official Title
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Sustained Therapeutic Effects of Percutaneous Tibial Nerve Stimulation

Conditions
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Urinary Bladder, Overactive

Intervention / Treatment
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* Device: Urgent PC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Urgent PC<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urgent PC, Overactive Bladder, SUmiT Trial, Overactive Urinary Bladder