Status:
NOT_YET_RECRUITING
Sacral Neuromodulation in Patients With Double Incontinence
Lead Sponsor:
University Hospital Ostrava
Conditions:
Double Incontinence
Faecal Incontinence
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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)...
Detailed Description
Faecal incontinence (FI) is defined as the involuntary loss of solid or liquid stool in patients. Incontinence harms the patient psychologically, socially and medically. FI is associated with an incre...
Eligibility Criteria
Inclusion
- 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
- 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 study enrollment
- Anatomical malformations of the sacrum that preclude implantation of the SNM electrode
- Low patient compliance
- Inability to control the neurostimulator
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07212387
Start Date
November 1 2025
End Date
December 1 2029
Last Update
October 8 2025
Active Locations (1)
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1
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia, 708 52