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Pilot Study of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of IC/PBS

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ClinicalTrials.gov Identifier: NCT02550561
Recruitment Status : Completed
First Posted : September 15, 2015
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Felicia Lane, University of California, Irvine

Brief Summary:

In 2014, the American Urological Association updated it management algorithm for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS). As the algorithm progresses, interventions become increasingly invasive and morbid. 4th line treatment is sacral neuromodulation (SNM), involving a two stage surgical procedure and permanent device implantation. While the mechanism for decrease in IC/PBS symptoms is unknown, SNM is thought act through central and peripheral mechanisms related to afferent signaling, causing modification of pain and lower urinary tract sensation.¹

Percutaneous posterior tibial nerve stimulation (PTNS) is a method of peripheral neuromodulation targeting the same nerve roots as SNM, but with significantly fewer risks. The purpose of our research is to determine if PTNS is effective in the treatment of IC/PBS. The results of this study will suggest future directions and provide critical information to design studies to determine to what extent and in what situations PTNS may be effective.

The investigators will enroll subjects with IC/PBS and urinary frequency/urgency to treatment with 12 weekly treatments of PTNS. The investigators will assess symptoms and lower urinary tract function before, during and after the treatments. At the completion of treatments, subjects will be asked to enroll in post-study follow up monitoring to understand the duration of symptom effect.


Condition or disease Intervention/treatment Phase
Interstitial Cystitis Painful Bladder Syndrome Device: Posterior Tibial Nerve Stimulation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of Interstitial Cystitis/Painful Bladder Syndrome
Actual Study Start Date : June 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Posterior Tibial Nerve Stimulation
PTNS (under the brand name Urgent PC) is an FDA-approved device for the treatment of urinary urgency, urinary frequency and urge incontinence. It is often described as a peripheral form of neuromodulation (as opposed to SNM which is central neuromodulation at the level of the nerve root). PTNS involves 12 weeks of weekly 30 minute office-based treatment sessions with a small electrode placed slightly above the ankle in order to stimulate the S2-4 nerve roots. If benefits are obtained, 12 weeks of treatment is followed by spaced maintenance sessions at timing of provider and patient discretion.
Device: Posterior Tibial Nerve Stimulation
PTNS (under the brand name Urgent PC) is an FDA-approved device for the treatment of urinary urgency, urinary frequency and urge incontinence. It is often described as a peripheral form of neuromodulation (as opposed to SNM which is central neuromodulation at the level of the nerve root). PTNS involves 12 weeks of weekly 30 minute office-based treatment sessions with a small electrode placed slightly above the ankle in order to stimulate the S2-4 nerve roots.




Primary Outcome Measures :
  1. Primary Outcome Measure: Percentage of subjects improved global response assessment scale [ Time Frame: 12-14 weeks ]
    The primary outcome variable will be the percentage of subjects to report that they are moderately improved or markedly improved in overall symptoms compared to baseline on a 7-point global response assessment (GRA) scale. The GRA scale involves asking the question, "As compared to when you started the current study, how would you rate your overall symptoms now?". There are 7 possible responses: markedly worse, moderately worse, slightly worse, the same, slightly improved, moderately improved and markedly improved. This scale is the current standard for outcome in studies that are evaluating treatments and interventions for IC/PBS.


Secondary Outcome Measures :
  1. Composite Secondary Self-Reported Outcome Measures [ Time Frame: At baseline then validated at follow-up (12-14 weeks) ]
    (1) 24-Hour Voiding Diary including fluid intake amounts (ounces), void amount (ounces), leaks or accidents (yes or no), strong urge to urinate (yes or no), activity when you leaked or had an urge (description); (2) Visual Analog Scale rating of the severity of pain, (scale of 1-10); (3) Pelvis Pain and Urgency/Frequency Patient Symptom Scale Survey (scale 0-4); (4) O'Leary/Sant-Voiding and Pain indices Survey (scale 0-4/5).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • clinical diagnosis of IC/PBS
  • complaint of urinary urgency (sudden, compelling desire to pass urine which is difficult to defer) or urinary frequency (voiding >8 times per 24 hour period)
  • female
  • have undergone at least 1 course of a standard therapy for IC/PBS
  • 18 years of age or older

Exclusion Criteria:

  • not having undergone at least 1 course of a standard therapy for IC/PBS
  • having a pacemaker or implantable defibrillator
  • being prone to excessive bleeding
  • having nerve damage that could impact the posterior tibial nerve
  • pregnant or planning pregnancy during treatment course
  • non-English speaking
  • current malignancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02550561


Locations
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United States, California
University of California-Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
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Principal Investigator: Felicia Lane, MD University of California, Irvine

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Responsible Party: Felicia Lane, Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT02550561     History of Changes
Other Study ID Numbers: 2015-2010
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Felicia Lane, University of California, Irvine:
Posterior tibial nerve stimulation
PTNS
IC

Additional relevant MeSH terms:
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Syndrome
Pain
Cystitis
Cystitis, Interstitial
Disease
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases