Dual IncontinenceSaNDINCT02357784
Sacral Neuromodulation in Dual Incontinence: Ultrasound and Afferent Nerve Sensation Assessment
A study testing Neurometer in people with Dual Incontinence and Fecal Incontinence, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Dual Incontinence, Fecal Incontinence, Urinary Incontinence
- What is being tested?
- Neurometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Subject has diathermy
- Subject has QTc prolongation
- Subject has cardiac arrhythmia
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Medical Group's Integrated Pelvic Health Program
Chicago, Illinois, 60611
About this study
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.
Read the 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.
- Being tested
- Neurometer
- Keywords
- Sacral Neuromodulation, SNM, Dual Incontinence, Current Perception Threshold Testing, CPT Testing, Fecal Incontinence, Urinary Incontinence, Afferent Nerve Sensation, InterStim
- Medical subject headings
- Fecal Incontinence, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurometerDevice
Also called Neurometer CPT Testing, CPT Testing
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Neurometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Urethral and Anal Afferent Nerve Innervation at 3 Months Post Sacral Neuromodulation Device Implantation
Measured: Baseline and 3 months Post-Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionNov 2018
- Study completionNov 2018
Why it stopped: The study was terminated due to low enrollment and the investigators want to explore a different primary objective
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dual IncontinenceStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- American Urogynecologic Society
- Responsible party
- Principal investigator, Margaret Mueller, Northwestern University
- Investigators
- Margaret Mueller, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357784
- Sponsor's protocol ID
- STU00098840
- Acronym
- SaNDI
- Status last verified
- Feb 2023
- First submitted
- 21 Jan 2015
- Last updated
- 16 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacral Neuromodulation in Dual Incontinence: Ultrasound and Afferent Nerve Sensation Assessment
- ClinicalTrials.gov ID
- NCT02357784
- Acronym / sponsor ID
- SaNDI / STU00098840
- Keywords
- Sacral Neuromodulation, SNM, Dual Incontinence, Current Perception Threshold Testing, CPT Testing, Fecal Incontinence, Urinary Incontinence, Afferent Nerve Sensation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to low enrollment and the investigators want to explore a different primary objective
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- American Urogynecologic Society
- Study start
- Jan 2015
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 6 Feb 2015 (estimated)
- Results
- Posted 16 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Current Perception Threshold Testing | Experimental | Device: NeurometerThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeurometerAlso: Neurometer CPT Testing, CPT TestingThe 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. | Device | Current Perception Threshold Testing |
Primary outcome
Change From Baseline in Urethral and Anal Afferent Nerve Innervation at 3 Months Post Sacral Neuromodulation Device Implantation
Time frame: Baseline and 3 months Post-Treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Mueller, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurometer in people with Dual Incontinence and Fecal Incontinence, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Urethral and Anal Afferent Nerve Innervation at 3 Months Post Sacral Neuromodulation Device Implantation (time frame: Baseline and 3 months Post-Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.