N/A N=40 Randomized Double-blind Treatment

PTNS Versus Sham Efficacy in Treatment of BPS

Interstitial Cystitis Bladder Pain Syndromes

Bottom Line

View on ClinicalTrials.gov: NCT02747420 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2021

Primary outcome: Primary: Count of Participants With Patient Global Impression of Improvement (PG-I) Score = 1 or 2 — 2; 4 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: NURO TM (Device); Sham (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: NYU Langone Health
Primary completion: Jan 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Count of Participants With Patient Global Impression of Improvement (PG-I) Score = 1 or 2	2; 4	—
SECONDARY Visual Analog Scale (VAS)	—	—
SECONDARY O'Leary-Sant Pain Scores	—	—
SECONDARY Over Active Bladder-Questionnaire (OAB-Q)	—	—
SECONDARY The SF-12 (Short Form) Health Scale	—	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02747420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.