PTNS Versus Sham Efficacy in Treatment of BPS

Randomized Controlled Trial of PTNS Versus Sham Efficacy in Treatment of Bladder Pain Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Interstitial Cystitis Bladder Pain Syndromes
• Intervention / Treatment: Device: NURO TM; Device: Sham

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Post Tibial Nerve Stimulation Group (PTNS)	Device: NURO TM; The lower extremity will be palpated and a needle insertion site will be identified 5 cm from the medial malleolus and posterior to the tibia. Between the posterior margin of the tibia and the soleus muscle, a 34-gauge acupuncture-like needle will be inserted 3-4 cm to the tibial nerve. A grounding pad will be placed on the bottom of the foot just below the smallest toe. An inactive grounding pad will be placed on top of the foot above the small toe to be consistent with the sham pad placement. The needle and grounding pad will be connected to the stimulator and the stimulation will be increased from 0 to 10 Milli-ampere. The needle will be taped. The electrical current will be set by the subject and the mA will be recorded. A 30 minute stimulation session will be given at 20 Hz.; Other Names: Neuromodulation system, Medtronic Device Model # 3533; stimulator model NURO 100
Sham Comparator: Sham Group	Device: Sham; A needle will be inserted into the lower extremity approximately 5 cm cephalad from the medial malleolus and posterior to the tibia. A sham needle will be used a the tibial nerve insertion site. This will stimulate needle placement without puncturing the skin. The needle will be taped in place. The "grounding pad" from the transcutaneous electrical nerve stimulation (TENS) unit device will be placed on the bottom of the foot below the smallest toe. Another electrode will be placed on the top of the foot above the small toe for conduction. The TENS electrode will be connected to the TENS unit, at 20 Hz (the same as the PTNS group). The unit will be turned on and the stimulation will be increased to the subject's first sensory level. The subject will sense stimulation to either the bottom of the foot or the toe. the TENS unit will be on for a 30 minute test period. The TENS unit will be removed and the needle will be discarded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Count of Participants With Patient Global Impression of Improvement (PG-I) Score = 1 or 2	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	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Benjamin Brucker, MD, NYU Langone Health

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): January 18, 2019
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: April 19, 2016
• First Submitted That Met QC Criteria: April 20, 2016
• First Posted (Estimate): April 21, 2016

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 5, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Posterior Tibial Nerve Stimulation, Bladder
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Disease; Syndrome; Cystitis; Cystitis, Interstitial
• Other Study ID Numbers: 15-01447

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes