PTNS Versus Sham Efficacy in Treatment of BPS

Completed · Not applicable · Has a placebo group

Conditions studied: Interstitial Cystitis Bladder Pain Syndromes

In brief

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.

Key facts

Study ID

NCT02747420

Run by

NYU Langone Health

People needed

40

Starts

2016-06-01

Expected to finish

2020-03-01

Last updated by the study team

2021-01-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify 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 qualify if…

• 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

Where it is running

• New York University School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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