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Keep this study
Lead
NYU Langone Health
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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
Patients pregnant or planning to become pregnant during the study duration
Botox use in pelvic floor muscles within the last year
