Prolapse; FemaleSCUPPNCT06620211
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 study of Prolapse; Female, run by Cousin Biotech at 1 site in France.
Trial summary
An observational, multicenter study with retrospective recruitment and two data collection methods, one retrospective (medical records) and the other prospective (questionnaires). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prolapse; Female
- What is being tested?
- promontofixation, prolapse cure
- Type of treatment
- Surgery or procedure
- How many people
- 290 participants
- Where
- 1 siteFrance
- Study dates
- 23 Apr 2020to 19 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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].
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- promontofixation, prolapse cure
- Medical subject headings
- Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
promontofixation, prolapse cureProcedure or surgery
Patient who underwent surgery to place the Sacromesh® medical device (promontofixation) for a prolapse cure, between 2009 and 2018
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2020 - 2023
Secondary outcomes (3)
evaluation the tolerance of the Sacromesh® implant Rate and type of postoperative complications
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.
Measured: 2020 - 2023
evaluation the tolerance of the Sacromesh® implant qol
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%.
Measured: 2020 - 2023
evaluation the tolerance of the Sacromesh® implant postoperative pain
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%.
Measured: 2020 - 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start23 Apr 2020
- Primary completion19 Oct 2023
- Study completion19 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolapse; FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cousin Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620211
- Sponsor's protocol ID
- RC-P-T3-33
- Acronym
- SCUPP
- Status last verified
- Sep 2024
- First submitted
- 8 Dec 2023
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06620211
- Acronym / sponsor ID
- SCUPP / RC-P-T3-33
- Conditions
- Prolapse; Female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Cousin BiotechIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- 19 Oct 2023 (actual)
- Study completion
- 19 Oct 2023 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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].
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| promontofixation, prolapse curePatient who underwent surgery to place the Sacromesh® medical device (promontofixation) for a prolapse cure, between 2009 and 2018 | Procedure or surgery | – |
Primary outcome
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.
3 secondary outcomes
evaluation the tolerance of the Sacromesh® implant Rate and type of postoperative complications
Time frame: 2020 - 2023
evaluation the tolerance of the Sacromesh® implant qol
Time frame: 2020 - 2023
evaluation the tolerance of the Sacromesh® implant postoperative pain
Time frame: 2020 - 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prolapse; Female, run by Cousin Biotech at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RATE AND TYPE OF REINTERVENTION (time frame: 2020 - 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.