Modified Extension Study to the SUmiT Trial: Evaluation of Long Term Therapy With Percutaneous Tibial Nerve Stimulation (PTNS) for Overactive Bladder Symptoms
Condition: Urinary Bladder, Overactive
MeSH terms: Urinary Bladder, Overactive
Intervention: Urgent PC
Intervention 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).
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Urgent PC; Overactive Bladder; SUmiT Trial; Overactive Urinary Bladder

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.
    

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