Evaluation of the Safety, Performance, and Tolerability of the Sacromesh® Medical Device in the Treatment of Prolapse by Promontofixation in a Population of Patients Followed Over the Long Term. (SCUPP)

Cousin Biotech

Status: Completed

Conditions: Prolapse; Female

Treatments: Procedure: promontofixation, prolapse cure

Study type: Observational

Funder types: Industry

Identifiers

NCT06620211

RC-P-T3-33

Details and patient eligibility

About

An observational, multicenter study with retrospective recruitment and two data collection methods, one retrospective (medical records) and the other prospective (questionnaires).

Patients who meet the inclusion criteria and have none of the non-inclusion criteria will be selected using the computer database of each investigating center. Data from consultation visits and surgery data will be collected and filled in the observation books.

The patient will be contacted by the investigators to collect data on quality of life and the existence or absence of pain associated with implant placement at follow-up.

Enrollment: 290 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

The inclusion criteria for participation in the study are as follows:

• Patient who underwent surgery to place the Sacromesh® medical device for a prolapse cure, between 2009 and 2018 in one of the investigation centres participating in the study.

• Patient who has read the information note and has not formulated an -opposition.

• Adult patient with full mental capacity/capability

Exclusion criteria

• Patient under guardianship or curatorship

• Patient hospitalized at time of inclusion

• Patient with an adjacent pathology that may strongly interfere with her quality of life and VAS score.

• Patients with mental psychological pathology