N/A
N=16
Pilot Study of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of IC/PBS
Interstitial Cystitis · Painful Bladder Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02550561 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Primary Outcome Measure: Percentage of Subjects Improved Global Response Assessment Scale — 4; 3 Participants — p=0.317
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Posterior Tibial Nerve Stimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, Irvine
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Outcome Measure: Percentage of Subjects Improved Global Response Assessment Scale |
4; 3 | 0.317 |
| SECONDARY Composite Secondary Self-Reported Outcome Measures - Questionnaires |
3.4; 3.2; 15.5; 16.1; 8.3; 7.8 | 0.47 |
| SECONDARY Secondary Self-Reported Outcome Measures - 24 Hour Voiding Frequency |
10.3; 11.6 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02550561). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.