Completed

NCT Number: NCT02747420

PTNS Versus Sham Efficacy in Treatment of BPS

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.

Completed

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Key information

Conditions

Interstitial Cystitis Bladder Pain Syndromes

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Neuromodulation system, Medtronic Device Model # 3533, stimulator model NURO 100

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.

Primary outcomes

Count of Participants With Patient Global Impression of Improvement (PG-I) Score = 1 or 2

Time frame: 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 outcomes

Visual Analog Scale (VAS)

Time frame: 12 Weeks

Quality of Life Scores
O'Leary-Sant Pain Scores

Time frame: 12 weeks

pain intensity, location of pain and associated symptoms
Over Active Bladder-Questionnaire (OAB-Q)

Time frame: 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

Time frame: 12 Weeks

Used to evaluate quality of life of each subject at the three analysis intervals.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2020
First posted: Apr 21, 2016
Registry last updated: Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.