Superficial Peroneal Nerve Neuromodulation for Non-Obstructive Urinary Retention

NCT04000763 | Completed DMC FDA Device

• 1 other identifier: STUDY19010062
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Millions of Americans are suffering from underactive bladder (UAB). The impact of severe UAB, i.e. non-obstructive urinary retention (NOUR) on quality of life is significant because current treatment for non-obstructive urinary retention requires intermittent self-catheterization or an indwelling suprapubic catheter. Currently an effective drug for non-obstructive urinary retention does not exist. It is a therapeutic challenge for clinicians to successfully treat non-obstructive urinary retention. Sacral neuromodulation has been approved by the FDA since 1999 to treat non-obstructive urinary retention. It achieves \>50% improvement in bladder emptying (reducing the frequency of self-catheterization or increasing voided volume) in just over half of the patients. Sacral neuromodulation requires surgical implantation of a stimulator and a lead with 4 electrodes. The surgery and implant are invasive and expensive, preventing a broad application of this effective therapy to many non-obstructive urinary retention patients. The goal of this study is to develop a novel non-invasive neuromodulation therapy for non-obstructive urinary retention as an alternative. Specifically, the investigators will explore the possibility to translate into humans a recent discovery in cats of an excitatory reflex from the superficial peroneal nerve to the bladder to treat non-obstructive urinary retention. Therefore, in this study the investigators propose to develop a non-invasive, transcutaneous neuromodulation therapy for non-obstructive urinary retention that can be administered at home.

Conditions

Urinary Retention; Urinary Bladder, Underactive

Keywords

Bladder

Outcome Measures

Primary Outcomes (6)

• Number of voids per subject in 24 hours.

  Counted using a patient voiding diary both before and after superficial peroneal nerve stimulation.

  3 weeks

• Number of catheterizations per subject in 24 hours.

  Counted using a patient voiding diary both before and after superficial peroneal nerve stimulation.

  3 weeks

• Volume of urine per void.

  Calculated in millimeters both before and after peroneal nerve stimulation.

  3 weeks

• Catheterized Post Void Residual volume

  Calculated in millimeters both before and after peroneal nerve stimulation.

  3 weeks

• Bladder Voiding efficiency

  Pre voiding and post voiding ratio that reflects bladder contractility

  3 weeks

• Bladder capacity

  Calculated by adding the voided volume to the post residual catheterization volume, in milliliters

  3 weeks

Secondary Outcomes (3)

• Efficacy of Foot Stimulation

  2 weeks

• Efficacy of Foot Stimulation

  3 weeks

• Post-stimulation effect

  1 week

Study Arms (1)

Transcutaneous Nerve Stimulator(TENS)

EXPERIMENTAL

Adult females who have difficulty emptying their bladder due to non-obstructive urinary retention or because of an under-active bladder will be given transcutaneous nerve stimulation (TENS) therapy.

Device: superficial peroneal nerve stimulation

Interventions

superficial peroneal nerve stimulation DEVICE

A commercially available FDA-approved transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes will be used to stimulate the foot. The electrodes will be attached to the dorsal surface of the foot and a sock will be placed over the foot to prevent detachment of the electrodes. Based on our animal studies, foot stimulation parameters of 2 Hz frequency and 0.2 ms pulse width will be used at the maximal intensity comfortable for each patient. It is expected that superficial peroneal nerve stimulation in patients can increase bladder sensation so that micturition can be initiated at a small bladder volume, or it can initiate bladder contraction at a small bladder volume and enhance the contraction or prolong the duration of contraction. Any of these excitatory effects, if occurs in human patients, will certainly improve the condition of non-obstructive urinary retention.

Transcutaneous Nerve Stimulator(TENS)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide informed consent
• years of age and older
• Clinically diagnoses as non-obstructive urinary retention
• Post Void Residual of 300 mL or greater
• Currently using daily self-catheterization to empty the bladder
• Capable of using the toilet independently without difficulty
• Capable and willing to follow all study-related procedures

You may not qualify if:

• Neurologic diagnosis (including diabetes mellitus)
• Surgery within one year of screening for urinary outlet obstruction
• Pregnant or planning to become pregnant during study duration
• OnabotulinumtoxiA use in bladder or pelvic floor muscles with the past year
• Pacemaker or implantable defibrillator
• Current Urinary tract or vaginal infections
• Current Interstim use
• Current Percutaneous tibial nerve stimulation (PTNS) or transcutaneous electrical nerve stimulation (TENS) use in pelvis or back or legs
• Investigational drug/ device therapy with the past 4 weeks,
• Participation in any clinical investigation involving or impacting gynecologic or urinary function with the past 4 weeks,
• Previous surgery of or damage to the foot or nerves in the foot and leg.

Sponsors & Collaborators

• Christopher J Chermansky, MD: lead
• Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction: collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

UPMC Urology

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (10)

• 26872574

  BACKGROUND

• Juszczak K, Drewa T. Pharmacotherapy in detrusor underactivity: A new challenge for urologists and pharmacologists (from lab to clinic). Pharmacol Rep. 2016 Aug;68(4):703-6. doi: 10.1016/j.pharep.2016.03.007. Epub 2016 Mar 19.

  PMID: 27110877 BACKGROUND

• Kessler TM, Fowler CJ. Sacral neuromodulation for urinary retention. Nat Clin Pract Urol. 2008 Dec;5(12):657-66. doi: 10.1038/ncpuro1251. Epub 2008 Nov 11.

  PMID: 19002127 BACKGROUND

• De Ridder D, Ost D, Bruyninckx F. The presence of Fowler's syndrome predicts successful long-term outcome of sacral nerve stimulation in women with urinary retention. Eur Urol. 2007 Jan;51(1):229-33; discussion 233-4. doi: 10.1016/j.eururo.2006.06.031. Epub 2006 Jul 10.

  PMID: 16860462 BACKGROUND

• Faraj K, Doo F, Boura J, Vereecke A, Chancellor MB. A cross-sectional study in the USA of the epidemiology and quality of life of underactive bladder symptoms. Int Urol Nephrol. 2016 Nov;48(11):1797-1802. doi: 10.1007/s11255-016-1382-0. Epub 2016 Jul 29.

  PMID: 27473156 BACKGROUND

• Abarbanel J, Marcus EL. Impaired detrusor contractility in community-dwelling elderly presenting with lower urinary tract symptoms. Urology. 2007 Mar;69(3):436-40. doi: 10.1016/j.urology.2006.11.019.

  PMID: 17382138 BACKGROUND

• Goodwin RJ, Swinn MJ, Fowler CJ. The neurophysiology of urinary retention in young women and its treatment by neuromodulation. World J Urol. 1998;16(5):305-7. doi: 10.1007/s003450050072.

  PMID: 9833308 BACKGROUND

• Jonas U, Fowler CJ, Chancellor MB, Elhilali MM, Fall M, Gajewski JB, Grunewald V, Hassouna MM, Hombergh U, Janknegt R, van Kerrebroeck PE, Lylcklama a Nijeholt AA, Siegel SW, Schmidt RA. Efficacy of sacral nerve stimulation for urinary retention: results 18 months after implantation. J Urol. 2001 Jan;165(1):15-9. doi: 10.1097/00005392-200101000-00004.

  PMID: 11125353 BACKGROUND

• Yu M, Uy J, Jiang X, Li X, Jones C, Shen B, Wang J, Roppolo JR, de Groat WC, Tai C. An excitatory reflex from the superficial peroneal nerve to the bladder in cats. Am J Physiol Renal Physiol. 2017 Nov 1;313(5):F1161-F1168. doi: 10.1152/ajprenal.00265.2017. Epub 2017 Aug 30.

  PMID: 28855188 BACKGROUND

• Tai C, Shen B, Chen M, Wang J, Roppolo JR, de Groat WC. Prolonged poststimulation inhibition of bladder activity induced by tibial nerve stimulation in cats. Am J Physiol Renal Physiol. 2011 Feb;300(2):F385-92. doi: 10.1152/ajprenal.00526.2010. Epub 2010 Nov 24.

  PMID: 21106856 BACKGROUND

MeSH Terms

Conditions

Urinary Retention; Urinary Bladder, Underactive

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher Chermansky, MD

  University of Pittsburgh

  STUDY DIRECTOR

Study Design

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

Model Details: All experiments proposed in this grant application will be performed in female non-obstructive urinary retention patients. We chose not to study male patients in this study given the need to exclude bladder outlet obstruction from benign prostatic hyperplasia (BPH), an evaluation that is invasive and costly.

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: June 27, 2019
• Study Start: December 20, 2019
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After all data is collected and analyzed.
• Access Criteria: Data Use Agreement Institutional Review Board approval.

Locations

US (1)