NCT02776475

The Effects of Sacral Neuromodulation for Urinary Urgency, Frequency, and Urge Incontinence

Are the Effects of Sacral Neuromodulation for Urinary Urgency, Frequency, and Urge Incontinence Maintained With the Device Temporarily Turned Off?

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: TriHealth Inc. · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This prospective one group cohort study seeks to investigate the effects of sacral neuromodulation on urinary urgency, frequency and urge incontinence are maintained after the simulator device is temporarily turned off for a period of four weeks.

Detailed description

Urinary urgency, frequency, and urge incontinence are very common symptoms, affecting up to one in three adults in the United States. The total economic cost of these disorders was estimated to be above $12 billion in the year 2000, with the vast majority being for women. Sacral neuromodulation (SNM) has become a popular and successful treatment option for people who suffer from these conditions. Sacral neuromodulation device delivers electrical pulses to an area near the sacral nerve. There has been some data published which showed that for patients with fecal incontinence, symptom relief can persist for significant time periods despite having the stimulator device turned off. Based on their findings, potential exists to prolong battery life if patients can cycle the on and off periods for their device while keeping their symptoms stable. The typical battery life of the implantable pulse generator (IPG) is approximately 5 years depending on the system settings. When the IPG is at the end of its battery life, a new IPG must be implanted. The cost of replacing the IPG ranges from $13,952 to $16,470. IPG replacement must be done in the operating room and requires the patient to undergo anesthesia and its associated risks. This study will investigate whether the symptoms of urinary urgency, frequency, and urge incontinence remain stable in patients with SNM with the device turned off for a period of four weeks. Current Cincinnati Urogynecology Associates (CUA) patients who are currently being successfully treated with sacral neuromodulation for the primary diagnosis of urinary urge incontinence or urgency and frequency who elect participate in the study will have the device turned off for four consecutive weeks. Their symptoms will be monitored during this time period.

Conditions

• Urinary Urge Incontinence

Interventions

Type	Name	Description
PROCEDURE	Sacral neuromodulation device turned off	Each patient will be to have the sacral neuromodulation device turned off for four consecutive weeks.

Timeline

• Start date: 2016-08-04
• Primary completion: 2021-05-27
• Completion: 2021-05-27
• First posted: 2016-05-18
• Last updated: 2022-11-10

Locations

1 site across 1 country: United States