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.

NCT06620211 | Completed

• 1 other identifier: RC-P-T3-33
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prolapse; Female

Outcome Measures

Primary Outcomes (1)

• RATE AND TYPE OF REINTERVENTION

  safety assessment of Sacromesh® implan through the documentation, within the French healthcare context, of the rate and type of re-interventions after Sacromesh® implantation. Collection and documentation of the nature and frequency of reinterventions after placement of the Sacromesh® device, including causes and nature of eventual explants, be it total or partial. The rate of re intervention will be calculated using Yes/No answer to POP recurrence question in the CRF. Yes answer to the question will be considered as a re intervention. In case of any POP recurrence investigator was asked to fill an adverse event form to describe the re intervention. Type of re intervention will be derived from AE form into a two classes categorical variable taking either 'De novo prolapse (recurrence, vaginal extrusion)' or 'Other' value. Both rate of re intervention and type of re intervention will be described as qualitative variables.

  2020 - 2023

Secondary Outcomes (3)

• evaluation the tolerance of the Sacromesh® implant Rate and type of postoperative complications

  2020 - 2023

• evaluation the tolerance of the Sacromesh® implant qol

  2020 - 2023

• evaluation the tolerance of the Sacromesh® implant postoperative pain

  2020 - 2023

Interventions

promontofixation, prolapse cure PROCEDURE

Patient who underwent surgery to place the Sacromesh® medical device (promontofixation) for a prolapse cure, between 2009 and 2018

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Prolapse cure, female only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

SCUPP is an observational retrospective study without any planed comparison. This is a multicentric study and from the center with the best recruitment potential, 5 centers were selected. The primary endpoint is the rate of reoperation which is expected to be very small according to previous investigation for Sacromesh® and according to literature. For example, a study investigated perioperative and mid-term clinical outcomes after laparoscopic sacrocolpopexy (LSCP) with light titanium-coated polypropylene (TCP) mesh in a large group of patients affected by International Continence Society stage II-IV pelvic organ prolapse (POP) reported a posterior recurrence of about 0.4% (1 out of 217 patients) \[Campagna et al., 2020\]. Another study investigating the Robotic sacrocolpopexy (RSCP) option for the treatment of apical, anterior, and proximal posterior compartment pelvic organ prolapses reported a POP recurrence of about 2% (2 out of 91 patients) \[Li Marzi et al., 2022\].

You may qualify if:

• 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

You may not qualify if:

• Patient under guardianship or curatorship
• Patient with an adjacent pathology that may strongly interfere with her quality of life and VAS score.
• Patients with mental psychological pathology

Sponsors & Collaborators

• Cousin Biotech: lead

Study Sites (1)

Cousin Biotech

Wervicq-Sud, 59117, France

Location

MeSH Terms

Conditions

Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: October 1, 2024
• Study Start: April 23, 2020
• Primary Completion: October 19, 2023
• Study Completion: October 19, 2023
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

FR (1)