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

NCT02776475 | Terminated

• 1 other identifier: 16-019
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urinary Urge Incontinence

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (1)

Sacral neuromodulation device turned off

OTHER

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

Interventions

Sacral neuromodulation device turned off PROCEDURE

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

Sacral neuromodulation device turned off

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

Cincinnati Urogynecology Associates

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

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

Study Officials

• Rachel Pauls, MD

  TriHealth - Cincinnati Urogynecology Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 18, 2016
• Study Start: August 4, 2016
• Primary Completion: May 27, 2021
• Study Completion: May 27, 2021
• Last Updated: November 10, 2022

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)