Long-term Evaluation of the I-STOP Sling in Stress Urinary Incontinence Treatment

Prospective Study to the Evaluate the Long-term Use of Synthetic I-STOP® Device for Treatment of Stress Urinary Incontinence in Women

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06665698

Acronym

VIGI-ISTOP

Enrollment

500

Registered

2024-10-30

Start date

2024-11-30

Completion date

2034-12-31

Last updated

2024-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Urinary Incontinence (SUI)

Keywords

I-STOP, MUS, Sling

Brief summary

Evaluate quality of life and rate of reoperation after implantation of the I-STOP sling for stress urinary incontinence

Detailed description

This is a prospective, multicenter, non-comparative, interventional post-marketing clinical follow-up study (PMCF) on a population of patients with SUI requiring surgical treatment with implantation of an I-STOP sling to document safety, the performance and effectiveness in the short, medium, and long term of these I-STOP® implants used in their intended purpose.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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; * Patient able to understand the protocol and follow the visit schedule; * Patient having signed informed consent.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Rate of reintervention	One year after surgery and after each year during 10 years	Questionnaire sent every year to the patient with question about revision surgery: yes / no

Secondary

Measure	Time frame	Description
Quality of Life	One year after surgery and after each year during 10 years	Questionnaire sent every year: Pelvic Floor Impact Questionnaire-short form 7 (PFIQ-7)

Contacts

Primary ContactVincent Goria

contact@dilomedical.fr+33478425845

Outcome results