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Evaluate quality of life and rate of reoperation after implantation of the I-STOP sling for stress urinary incontinence
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of reintervention | Questionnaire sent every year to the patient with question about revision surgery: yes / no | One year after surgery and after each year during 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | Questionnaire sent every year: Pelvic Floor Impact Questionnaire-short form 7 (PFIQ-7) | One year after surgery and after each year during 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincent Goria | Contact | +33478425845 | contact@dilomedical.fr |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |