PTNS Versus Sham Efficacy in Treatment of BPS

NCT02747420 | Completed Results FDA Device

• 1 other identifier: 15-01447
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Cystitis Bladder Pain Syndromes

Keywords

Posterior Tibial Nerve Stimulation, Bladder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Visual Analog Scale (VAS)

  12 Weeks

• O'Leary-Sant Pain Scores

  12 weeks

• Over Active Bladder-Questionnaire (OAB-Q)

  12 Weeks

• The SF-12 (Short Form) Health Scale

  12 Weeks

Study Arms (2)

Post Tibial Nerve Stimulation Group (PTNS)

EXPERIMENTAL

Device: NURO TM

Sham Group

SHAM COMPARATOR

Device: Sham

Interventions

NURO TM DEVICE

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.

Also known as: Neuromodulation system, Medtronic Device Model # 3533, stimulator model NURO 100

Post Tibial Nerve Stimulation Group (PTNS)

Sham DEVICE

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.

Sham Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (1)

• 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.

  PMID: 32734597 DERIVED

Results Point of Contact

• Title: Dr. Benjamin Brucker
• Organization: NYU Langone Health

Benjamin.Brucker@nyulangone.org

+1 646 825 6300

Study Officials

• Benjamin Brucker, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: April 21, 2016
• Study Start: June 1, 2016
• Primary Completion: January 18, 2019
• Study Completion: March 1, 2020
• Last Updated: January 26, 2021
• Results First Posted: January 26, 2021

Record last verified: 2021-01

Locations

US (1)