PTNS for Female Patients Suffering From Multiple Sclerosis — PTNS-MS  

Multiple Sclerosis Clinical Trial

Official title: Percutaneous Tibial Nerve Stimulation (PTNS) Therapy for Female Patients Suffering From Multiple Sclerosis

Status Recruiting

Clinical Trial Summary

This is a pilot, single blind, randomized, sham-controlled trial to assess the benefit of PTNS in treating OAB symptoms in MS patients. The data generated by this study would provide support for a future multi-institutional, randomized prospective trial.

Clinical Trial Description

Multiple Sclerosis (MS) is a chronic, progressive inflammatory disorder of the central nervous system. It is caused by loss of myelin, the outer protective layer of the neuron, resulting in a disruption of the signal potentials that flow through the neurons. This can lead to a variety of sensory, visual, and motor disturbances. MS affects almost 1 million people in the United States with the prevalence being two to three times higher in women than in men. Over 80% of MS patients suffer from lower urinary tract symptoms, with bladder overactivity (OAB) and urinary incontinence (UI) being the predominant bladder dysfunctions. OAB is characterized by sudden feeling of urgency, frequent urination, and urge incontinence. Percutaneous Tibial Nerve Stimulation (PTNS) is an FDA approved treatment for OAB and is recommended as third line treatment for OAB by the American Urological Association (AUA) and Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU). However, it is not approved for MS and as such these treatments are not covered by insurance.

Here the investigators propose a pilot, double blind, randomized, sham-controlled trial to assess the benefit of PTNS in treating OAB symptoms in MS patients. The data generated by this study would provide support for a future multi-institutional, randomized prospective trial. ;

Related Conditions & MeSH terms

• Multiple Sclerosis
• Overactive Bladder
• Sclerosis
• Urinary Bladder, Overactive

• NCT number: NCT05422625
• Study type: Interventional
• Source: William Beaumont Hospitals
• Contact: Amanda Schonhoff, RN, BSN
• Phone: 248-551-1225
• Email: amanda.schonhoff@beaumont.org
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2023
• Completion date: October 2023