PTNS Versus Sham Efficacy in Treatment of BPS

Not Applicable

Completed

• Conditions: Interstitial Cystitis Bladder Pain Syndromes
• Interventions: Device: Sham; Device: NURO TM

• Registration Number: NCT02747420
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-20
• Study First Posted: 2016-04-21
• Study Start: 2016-06
• Primary Completion: 2019-01-18
• Study Completion: 2020-03
• Results First Submitted: 2020-10-22
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-05
• Last Update Submitted: 2021-01-05
• Results First Posted: 2021-01-26
• Last Update Posted: 2021-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Group	Sham	-
Post Tibial Nerve Stimulation Group (PTNS)	NURO TM	-

Primary Outcome Measures

Name	Time	Method
Count of Participants With Patient Global Impression of Improvement (PG-I) Score = 1 or 2	12 weeks	A single item questionnaire assessing overall impression of improvement over time at the initial 12 weeks endpoint.; Patients are asked to describe their condition compared to how it was before intervention on a scale from 1 to 7: Very much better = 1 Much better = 2 A little better = 3 No change = 4 A little worse = 5 Much worse = 6 Very much worse = 7

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	12 Weeks	Quality of Life Scores
O'Leary-Sant Pain Scores	12 weeks	pain intensity, location of pain and associated symptoms
Over Active Bladder-Questionnaire (OAB-Q)	12 Weeks	This will allow for evaluation of subjects with concomitant overactive bladder and painful bladder syndrome characteristics.
The SF-12 (Short Form) Health Scale	12 Weeks	Used to evaluate quality of life of each subject at the three analysis intervals.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States