Evolution of Symptoms After Anterior Sacrospinofixation by Autologous Tissues (NCT04270188) | Clinical Trial Compass
CompletedNot Applicable
Evolution of Symptoms After Anterior Sacrospinofixation by Autologous Tissues
France66 participantsStarted 2020-07-21
Plain-language summary
Prolapse is a pathology that can cause pelvic, urinary or sexual functional disorders and impaired quality of life. Although the use of vaginal mesh is a commonly practiced technique to correct prolapse, in recent years health officials have pointed to the lack of adequate safety and tolerability assessments of these implants. Currently, surgeons are therefore moving towards techniques without implants. The standard vaginal technique for the treatment of uterine prolapse is sacrospinofixation according to Richter. This technique can be performed without an implant, using autologous tissue.
Functional discomfort of patients is the main problem linked to the presence of prolapse. However, no study has yet evaluated the feelings of patients following the use of this sacrospinofixation technique by autologous tissues by vaginal route, which led us to set up this study.
The hypothesis is that the technique of anterior sacrospinofixation by autologous tissues improves the symptoms experienced by patients with an mid-level and / or anterior genital prolapse.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* women over 18
* middle and / or anterior genital prolapse (hysterocele and / or cystocele) requiring surgical correction of stage ≥ II in the POP-Q classification
* patients wanting an intervention because of the discomfort caused by the prolapse
* intervention planned by anterior sacrospinofixation by autologous tissues
* person having expressed his non-opposition
Exclusion Criteria:
* prolapse of stage \< II in the POP-Q classification, or prolapse without functional impairment
* disorders involving an unacceptable risk of postoperative complications sought after questioning of the patient (blood coagulation disorders, immune system disorders, progressive diseases, etc.)
* reduced mobility of the lower limbs (not allowing positioning for surgery)
* pregnancy or any pregnancy plan for the duration of the study
* active or latent infection
* inability to understand the information given
* person deprived of liberty, under guardianship.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.