Sacral Neuromodulation in Patients With Double Incontinence
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital Ostrava
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Grade III fecal incontinence (patient is unable to consciously hold in wind, loose or hard stools)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Sacral neurostimulation
Procedure/SurgerySacral neurostimulation (SNS), or sacral neuromodulation (SNM), is a minimally invasive, reversible treatment for bladder and bowel control problems, including overactive bladder and fecal incontinence.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Sacral neuromodulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall effect of SNM
Evaluation of the overall effect of SNM in patients with DI from the patient's perspective using the so-called "patients reported outcome measures" (PROM) with the Patient Global Impression - Improvement questionnaire will be performed.
Time frame
18 monthsSecondary outcomes
1
The number of responders at the end of the test phase
The number of responders at the end of the test phase will be observed
Time frame
2 weeks for the patient, 4 years for the investigator2
Bladder and bowel diary - the number of FI episodes
The number of FI episodes from the bladder and bowel diary will be observed for the monitored period of 3 and 7 days
Time frame
3 and 7 days3
Bladder and bowel diary - the number of faecal urgency episodes
The number of faecal urgency episodes from the bladder and bowel diary will be observed for the monitored period of 3 and 7 days
Time frame
3 and 7 days4
Bladder and bowel diary - the number of UI episodes
The number of UI episodes from the bladder and bowel diary will be observed for the monitored period of 3 and 7 days
Time frame
3 and 7 daysSponsors and contacts
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Source ClinicalTrials.gov
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