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
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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 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.
- 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).
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
|United States, California|
|University of California-Irvine Medical Center|
|Orange, California, United States, 92868|
|Principal Investigator:||Felicia Lane, MD||University of California, Irvine|