Sacral Neuromodulation in Dual Incontinence: Ultrasound and Afferent Nerve Sensation Assessment

NCT02357784 | Terminated Results

• 1 other identifier: STU00098840
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Women with Dual Incontinence (DI) (both Urinary Incontinence (UI) and Fecal Incontinence (FI)) often have more bothersome symptoms, quality of life impact, and sexual dysfunction than those with just UI or FI. In many situations, DI is the result of a failure of communication between the brain and the sacral nerve, which controls the bladder, bowel, and pelvic floor. The only currently available treatment with level 1 effectiveness data for the treatment of BOTH UI and FI is called Sacral Neuromodulation (SNM). Sacral Neuromodulation is a standard of care treatment that involves surgically implanting a device in to a patient's body to target communication issues between their brain and bladder/bowel. Because the exact mechanism of action of SNM remains unclear, this study aims to better understand how SNM affects the nerves of patients with DI. Patients who are already planning on undergoing SNM device implantation will be recruited to this study. Study participants will undergo Current Perception Threshold (CPT) Testing and fill out questionnaires before SNM and 3 months after their SNM treatment. CPT Testing uses mild electrical stimulation in the urethra and rectum to measure and quantify the amount of physical stimuli required for the nerves in the pelvic floor to sense a stimulus. By learning more about nerve function in patients with DI, the investigators hope to find a way to screen patients before treatment with SNM to make sure the treatment will be effective for that individual.

Conditions

Dual Incontinence; Fecal Incontinence; Urinary Incontinence; Sacral Neuromodulation

Keywords

Sacral Neuromodulation; SNM; Dual Incontinence; Current Perception Threshold Testing; CPT Testing; Fecal Incontinence; Urinary Incontinence; Afferent Nerve Sensation; InterStim

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Urethral and Anal Afferent Nerve Innervation at 3 Months Post Sacral Neuromodulation Device Implantation

  Baseline and 3 months Post-Treatment

Study Arms (1)

Current Perception Threshold Testing

EXPERIMENTAL

The subjects in this study will undergo Current Perception Threshold Testing and fill out several questionnaires both before their Sacral Nerve Modulator device implantation and again 3 months after the device implantation.

Device: Neurometer

Interventions

Neurometer DEVICE

The purpose of Current Perception Threshold (CPT) testing is to help physicians better understand how Sacral Neuromodulation affects the nerves of patients with dual incontinence. CPT Testing involves the use of a portable battery-operated machine which will stimulate the subject's nerves via an electrical stimulation. Electrodes will be placed via a catheter in to the subject's urethra and rectum, and the electrical current will be increased gradually until the subject feels the onset of tingling, buzzing, or warmth at the site of the electrode. The electrical current will then gradually decrease until no sensation of stimulation is felt. The procedure will then be repeated where the subject will be asked to hold the test button to increase the stimulus intensity above their sensory threshold (above the point where they can feel it) until the device automatically shuts off.

Also known as: Neurometer CPT Testing, CPT Testing

Current Perception Threshold Testing

Eligibility Criteria

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

You may qualify if:

• Subject is a female over the age of 18 years old
• Subject is diagnosed with idiopathic dual incontinence
• Subject is planning to undergo placement of a sacral nerve modulator
• Subject has at least 5 UUI episodes on a 3-day diary
• Subject has 2 FI episodes on a 7-day diary
• Subject has given signed, informed consent prior to registration on study

You may not qualify if:

• Subject has a neurologic disease
• Subject has a disease that may impair sphincter tone or sensation
• Subject is pregnant
• Subject has \> Stage II pelvic organ prolapse
• Subject underwent rectal surgery in the past year
• Subject has chronic inflammatory bowel disease
• Subject has diathermy
• Subject has QTc prolongation
• Subject has cardiac arrhythmia

Sponsors & Collaborators

• Northwestern University: lead
• American Urogynecologic Society: collaborator

Study Sites (1)

Northwestern Medical Group's Integrated Pelvic Health Program

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Fecal Incontinence; Urinary Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; 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

Results Point of Contact

• Title: Dr. Margaret Mueller
• Organization: Northwestern University

mgmueller@nm.org

13124723874

Study Officials

• Margaret Mueller, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: February 6, 2015
• Study Start: January 1, 2015
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: February 16, 2023
• Results First Posted: February 16, 2023

Record last verified: 2023-02

Locations

US (1)