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

Urinary Urge Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02776475
• Other study ID #: 16-019
• Status: Terminated
• Phase: N/A
• Start date: August 4, 2016
• Est. completion date: May 27, 2021

Study information

• Verified date: October 2020
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: May 27, 2021
• Est. primary completion date: May 27, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Women, aged 18-85 with who have previously had the InterStim device implanted and have experienced good control of their symptoms for at least one year.

Exclusion Criteria:

• Patients with less than 6 months of expected battery life on their device established at office testing.
• Patients with poor control of their symptoms within the last one year.
• Patients with degenerative neurological disorders or spinal cord injuries.
• Patients with cognitive disabilities or those lacking the mental capacity to understand and answer questionnaires.
• Patients who are pregnant or may become pregnant.

Related Conditions & MeSH terms

• Urinary Incontinence, Urge
• Urinary Urge Incontinence

Intervention

Procedure:
• Sacral neuromodulation device turned off
Each patient will be to have the sacral neuromodulation device turned off for four consecutive weeks.

Locations

Country	Name	City	State
United States	Cincinnati Urogynecology Associates	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in scores on the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) from baseline with the SNM device compared to having the device turned off for a period of four weeks		The outcome measure is assessing change between initial baseline and 4 weeks after turning off the device.
Primary	The difference in scores on the International Consultation on ICIQ-SF from baseline with the SNM device compared to having the device turned off for a period of up to six months		The outcome measure is assessing change between initial baseline and 6 months after turning off the device.