Long-term Evaluation of the I-STOP Sling in Stress Urinary Incontinence Treatment
ConditionStress Urinary Incontinence (SUI)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorDILO Medical
About this trial
Evaluate quality of life and rate of reoperation after implantation of the I-STOP sling for stress urinary incontinence
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult woman aged over 18 ;
Patient with SUI, having escaped "conservative" medical treatment, with indication for surgical treatment with implantation of an I-STOP® strip via trans-obturator or retropubic route as indicated in the instructions for use of the SUI implant ;
Patient affiliated to a social security scheme;
Patient capable of completing a self-questionnaire;
Disqualifiers
Minor patient, pregnant or breastfeeding ;
Adult patient subject to a measure of legal protection, guardianship, curatorship or deprived of liberty by judicial or administrative decision ;
Patient presenting a contraindication to the use of the implant indicated in the instructions for use of the implant ;
Patient with a medical contraindication to surgery and/or anaesthesia.
Trial population
The study population is made up of patients with SUI who should benefit from the implantation of an I-STOP® implant in one of the centers associated with the project.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Rate of reintervention
Questionnaire sent every year to the patient with question about revision surgery: yes / no
Time frame
One year after surgery and after each year during 10 yearsSecondary outcomes
1
Quality of Life
Questionnaire sent every year: Pelvic Floor Impact Questionnaire-short form 7 (PFIQ-7)
Time frame
One year after surgery and after each year during 10 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: