Sacral Neuromodulation in Patients With Double Incontinence (NCT07212387) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Sacral Neuromodulation in Patients With Double Incontinence
Czechia30 participantsStarted 2025-11
Plain-language summary
This is a prospective study evaluating the effect of a treatment method of sacral neuromodulation (SNM), the use of which is approved and recommended for the treatment of both faecal incontinence (FI) and urinary incontinence (UI). A new aspect of the study is monitoring the effect of SNM in patients with both types of incontinence (faecal and urinary) occurring simultaneously. The study will use diagnostic methods and procedures that are part of the usual examination algorithm. The study will not impose any burden on patients beyond the scope of routine examination and treatment procedures.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult women over 18 years of age
* Consent to participate in the study
* Willingness to undergo examination, treatment and follow-up according to the protocol
* DI symptoms characterized by:
* Grade III fecal incontinence (patient is unable to consciously hold in wind, loose or hard stools)
* At least 2 episodes of fecal incontinence during the week (according to bladder and bowel diary)
* At least 1 episode of involuntary urine leakage per day (according to bladder and bowel diary)
* Total score of the ICIQ-UI SF questionnaire
* DI symptoms for more than 6 months
* Failure of previous conservative treatment
Exclusion Criteria:
* Rapidly progressing neurological diseases
* Known severe congenital malformations of the anorectum and/or lower urinary tract
* Presence of a foreign body in the urinary tract - urolithiasis, urinary catheter, ureteral stent
* Pregnancy, lactation
* Active urinary tract infection
* Active malignant disease
* Clinically significant pelvic organ prolapse
* Active inflammatory bowel disease (Crohn's disease, ulcerative colitis)
* In the case of an associated lesion of the external anal sphincter, a defect greater than 90 degrees
* Previous pelvic radiotherapy less than 12 months prior to study enrolment
* Previous pelvic organ descent surgery less than 12 months prior to study enrolment
* Previous stress urinary incontinence surgery less than 12 months prior to study enrolment
* Previous childbirth less than 12 months prior to s…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.