ClinicalTrials.Veeva

Menu

PTNS Versus Sham Efficacy in Treatment of BPS

NYU Langone Health logo

NYU Langone Health

Status

Completed

Conditions

Interstitial Cystitis Bladder Pain Syndromes

Treatments

Device: Sham
Device: NURO TM

Study type

Interventional

Funder types

Other

Identifiers

NCT02747420
15-01447

Details and patient eligibility

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

40 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy 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

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Post Tibial Nerve Stimulation Group (PTNS)
Experimental group
Treatment:
Device: NURO TM
Sham Group
Sham Comparator group
Treatment:
Device: Sham

Trial documents
1

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems