Have you or your loved ones been diagnosed with interstitial cystitis bladder pain syndromes?

You may be eligible to participate in a interstitial cystitis bladder pain syndromes clinical trial.

Have you or your loved ones been diagnosed with interstitial cystitis bladder pain syndromes? You may be eligible to participate in a interstitial cystitis bladder pain syndromes clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Interstitial Cystitis Bladder Pain Syndromes Clinical Trial in New York NY

NCT02747420 | Interventional

Have you or your loved ones been diagnosed with interstitial cystitis bladder pain syndromes?

You may be eligible to participate in a interstitial cystitis bladder pain syndromes clinical trial.

Have you or your loved ones been diagnosed with interstitial cystitis bladder pain syndromes? You may be eligible to participate in a interstitial cystitis bladder pain syndromes clinical trial.

Completed

Female

18 Years +

This study has recruited 40 Participants

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.

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Details for the study

Brief Title

PTNS Versus Sham Efficacy in Treatment of BPS

Official Title

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

Brief Summary

This is a prospective, single center, double-blind, randomized, controlled trial comparing <br /> the efficacy of percutaneous tibial nerve stimulation to sham in the treatment of Bladder <br /> 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.

Treatments and/or Procedures

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.

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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

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

O'Leary-Sant Pain Scores

pain intensity, location of pain and associated symptoms

12 weeks

Secondary

Over Active Bladder-Questionnaire (OAB-Q)

This will allow for evaluation of subjects with concomitant overactive bladder and painful bladder syndrome characteristics.

12 Weeks

Secondary

Visual Analog Scale (VAS)

Quality of Life Scores

12 Weeks

Secondary

The SF-12 (Short Form) Health Scale

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

12 Weeks

Study 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