Clinical trial NCT02747420: PTNS Versus Sham Efficacy in Treatment of BPS
Official title: Randomized Controlled Trial of PTNS Versus Sham Efficacy in Treatment of Bladder Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interstitial Cystitis Bladder Pain Syndromes
Keywords: Posterior Tibial Nerve Stimulation, Bladder
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-04-21
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Count of Participants With Patient Global Impression of Improvement (PG-I) Score = 1 or 2
timeFrame: 12 weeks
Secondary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 12 Weeks
measure: O'Leary-Sant Pain Scores
timeFrame: 12 weeks
measure: Over Active Bladder-Questionnaire (OAB-Q)
timeFrame: 12 Weeks
measure: The SF-12 (Short Form) Health Scale
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Benjamin Brucker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.