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

NCT02550561 | Completed Results DMC

• 1 other identifier: 2015-2010
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Cystitis; Painful Bladder Syndrome

Keywords

Posterior tibial nerve stimulation; PTNS; IC

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure: Percentage of Subjects Improved Global Response Assessment Scale

  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. Responders are those that marked either moderately or markedly improved.

  Visit 6 at 6 weeks and Visit 12 at 12 weeks

Secondary Outcomes (2)

• Composite Secondary Self-Reported Outcome Measures - Questionnaires

  At baseline then validated at follow-up (12-14 weeks)

• Secondary Self-Reported Outcome Measures - 24 Hour Voiding Frequency

  At baseline then validated at follow-up (12-14 weeks)

Study Arms (1)

Posterior Tibial Nerve Stimulation

EXPERIMENTAL

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

Interventions

Posterior Tibial Nerve Stimulation DEVICE

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.

Posterior Tibial Nerve Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead
• Kaiser Permanente: collaborator

Study Sites (1)

University of California-Irvine Medical Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Phuong Linh Huynh, CRC
• Organization: University of California, Irvine

plhuynh@hs.uci.edu

7144566155

Study Officials

• Felicia Lane, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: September 15, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: July 27, 2023
• Results First Posted: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)