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Completed

NCT Number: 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.

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.

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Key information

Conditions

Prolapse; Female Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Cousin Biotech

Wervicq-Sud, 59117, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

promontofixation, prolapse cure

Procedure

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

Primary outcomes

  1. RATE AND TYPE OF REINTERVENTION

    Time frame: 2020 - 2023

    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.

Secondary outcomes

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

    Time frame: 2020 - 2023

    Rate and type of postoperative complications The rate and type of postoperative complications will be presented as mean (standard deviation [SD]), median, 1st and 3rd quartiles, range, and the 95% (CI) based on the Student-t distribution.

  2. evaluation the tolerance of the Sacromesh® implant qol

    Time frame: 2020 - 2023

    Quality of life Two questionnaires will be assessed: PFIQ-7 and PFDI-20 questionnaires. Results will be presented as mean (standard deviation [SD]), median, 1st and 3rd quartiles, range, and the 95% (CI) based on the Student-t distribution. All applicable statistical tests will be two-sided and will be performed using a 5% significance level; CI presented will be 95%.

  3. evaluation the tolerance of the Sacromesh® implant postoperative pain

    Time frame: 2020 - 2023

    Postoperative pain Pain will be assessed with VAS scale and expressed as a mean (standard deviation [SD]), median, 1st and 3rd quartiles, range, and the 95% (CI) based on the Student-t distribution. All applicable statistical tests will be two-sided and will be performed using a 5% significance level; CI presented will be 95%.

Sponsors and collaborators

Lead sponsor

Cousin Biotech

Industry

Registry information

Acronym: SCUPP

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 1, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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