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

Stopped early · Not applicable

Conditions studied: Dual Incontinence, Fecal Incontinence, Urinary Incontinence, Sacral Neuromodulation

In brief

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.

Key facts

Study ID: NCT02357784
Run by: Northwestern University
People needed: 1
Starts: 2015-01-01
Expected to finish: 2018-11-01
Last updated by the study team: 2023-02-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

Northwestern Medical Group's Integrated Pelvic Health Program — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.