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

NCT ID: NCT02357784

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2018-11-30

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.

Detailed Description

One in four women reports bothersome symptoms of a pelvic floor disorder with 16% reporting urinary incontinence (UI), otherwise known as leakage. Likewise, 1 in 5 women with UI reports fecal incontinence (FI). Women with dual incontinence (UI/FI) often have more bothersome symptoms, quality of life impact, and sexual dysfunction than those with just UI or FI. In many situations, bladder and/or bowel control problems are the result of a failure of communication between the brain and the sacral nerve. The sacral nerve controls the bladder, bowel, and pelvic floor and the muscles related to their function. If the brain and sacral nerve do not communicate correctly, the bladder and/or bowel cannot function properly, which often leads to incontinence, or leakage. The only currently available treatment with level 1 effectiveness data for the treatment of BOTH UI and FI is called Sacral Neuromodulation. Sacral Neuromodulation (SNM) is a standard of care procedure used to treat men and women that have symptoms of Urinary and Fecal Incontinence and involves surgically implanting a device in to the patient's body to target this communication problem by stimulating the nerves that control bladder and bowel function with mild electrical pulses. This helps the brain and nerves to communicate so the bladder and bowel can function properly. It is known that changes in nerve stimulation and muscular function are important factors in the cause and onset of UI and FI and in how a patient will respond to various treatments, however, the precise mechanism of action of SNM on UI and FI remains unclear.

This study therefore aims to obtain a better understanding of nerve and muscle function in patients with dual incontinence and to quantify how SNM affects the nerves of patients with dual incontinence. We hope to do so by using Current Perception Threshold (CPT) Testing, which is a way to quantify the function of different populations of afferent nerves. We will recruit patients who already plan on undergoing Sacral Neuromodulation implantation for the treatment of their dual incontinence, and as part of the research study we will use CPT testing to measure the amount of stimulation required to activate the participant's sacral nerve before SNM and will also measure the current perception threshold of the participant's sacral nerve after SNM treatment. We expect to see a difference in the amount of stimulation required to activate different pelvic floor nerves before and after the device implantation. By learning more about nerve function in patients with DI, we hope to find a way to screen patients before treatment with SNM to make sure the treatment will work for them. We also hope to learn how urethral and anal sphincter anatomy in patients with dual incontinence changes after treatment with SNM. Lastly, we will study the quality of sexual relationships in women with dual incontinence and their male partners and attempt to identify specific areas of dysfunction that are common in patients with DI.

Conditions

Dual Incontinence; Fecal Incontinence; Urinary Incontinence; Sacral Neuromodulation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Current Perception Threshold Testing

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.

Group Type: EXPERIMENTAL

Neurometer

Intervention Type: 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.

Interventions

Neurometer

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.

Intervention Type: DEVICE

Other Intervention Names

Neurometer CPT Testing; CPT Testing

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

American Urogynecologic Society

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Margaret Mueller

Assistant Professor of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Margaret Mueller, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern Medical Group's Integrated Pelvic Health Program

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STU00098840

Identifier Type: -

Identifier Source: org_study_id