PTNS Versus Sham Efficacy in Treatment of BPS
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About
This is a prospective, single center, double-blind, randomized, controlled trial comparing the efficacy of percutaneous tibial nerve stimulation to sham in the treatment of Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC) through 12 weeks of therapy.
Full description
This is a pilot study to evaluate the efficacy of the systematic effects of posterior tibial nerve stimulation (PTNS) treatment compared to an inactive sham intervention in female subjects with interstitial cystitis/bladder pain syndrome (IC/BPS) in an intent-to-treat analysis. The primary outcome measure will be the Patient Global Impression of Improvement (PGI-I) a single item questionnaire assessing overall impression of improvement over time at the initial 12 weeks endpoint.
It is hypothesized that subjects randomized to the PTNS arm will demonstrate a greater improvement in both pain and quality of life scores, when compared with subjects who are randomized to the sham arm.
Enrollment
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Volunteers
Inclusion criteria
- Women ≥18 years old with visual analog scale > 5
- Cessation of all analgesics or other medication for pain for at least 2 weeks prior to the PTNS intervention
- Discontinuation of any other electrical stimulation methods for 3 months prior to PTNS intervention.
- Capable of giving informed consent
- Ambulatory
- Capable and willing to follow all study-relation procedures
Exclusion criteria
- Patients pregnant or planning to become pregnant during the study duration
- Botox use in pelvic floor muscles within the last year
- Current urinary or vaginal infections
- Current use of Interstim device
- History of a cardiac pacemaker
- Diagnosis of neuropathy
Trial design
Primary purpose
Allocation
Interventional model
Masking
40 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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