Clinical trial NCT06620211: 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.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prolapse; Female
Lead sponsor: Cousin Biotech
Sponsor class: INDUSTRY
First posted: 2024-10-01
Enrollment: 290
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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) \[Li Marzi et al., 2022\].

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.


Eligibility criteria: 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

Primary outcomes:
measure: RATE AND TYPE OF REINTERVENTION
timeFrame: 2020 - 2023
Secondary outcomes:
measure: evaluation the tolerance of the Sacromesh® implant Rate and type of postoperative complications
timeFrame: 2020 - 2023
measure: evaluation the tolerance of the Sacromesh® implant qol
timeFrame: 2020 - 2023
measure: evaluation the tolerance of the Sacromesh® implant postoperative pain
timeFrame: 2020 - 2023
Other outcomes:
Locations:
city: Wervicq Sud
country: France
facility: Cousin Biotech
Study officials:
References: