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

November 7, 2022 updated by: TriHealth Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Cincinnati Urogynecology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sacral neuromodulation device turned off
Patients who are currently being successfully treated with sacral neuromodulation for the primary diagnosis of urinary urge incontinence or urgency and frequency (implantation for minimum 12 months) will be to have the sacral neuromodulation device turned off for four consecutive weeks.
Procedure: Sacral neuromodulation device turned off
Each patient will be to have the sacral neuromodulation device turned off for four consecutive weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: The outcome measure is assessing change between initial baseline and 4 weeks after turning off the device.
The outcome measure is assessing change between initial baseline and 4 weeks after turning off the device.
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
Time Frame: The outcome measure is assessing change between initial baseline and 6 months after turning off the device.
The outcome measure is assessing change between initial baseline and 6 months after turning off the device.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TriHealth Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2016

Primary Completion (Actual)

May 27, 2021

Study Completion (Actual)

May 27, 2021

Study Registration Dates

First Submitted

May 3, 2016

First Submitted That Met QC Criteria

May 17, 2016

First Posted (Estimate)

May 18, 2016

Study Record Updates

Last Update Posted (Actual)

November 10, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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