Evolution of Symptoms After Anterior Sacrospinofixation by Autologous Tissues

Active, not recruiting

• Conditions: Pelvic Organ Prolapse
• Interventions: Other: evolution of patient symptoms

• Registration Number: NCT04270188
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2020-02-12
• Study First Posted: 2020-02-17
• Study Start: 2020-07-21
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-02-29
• Primary Completion: 2025-07-11
• Study Completion: 2025-07-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 66

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
anterior sacrospinofixation with autologous tissue	evolution of patient symptoms	patients with middle and / or anterior prolapse ≥ II in the POP-Q classification and for whom an intervention by anterior sacrospinofixation by autologous tissues is planned.

Primary Outcome Measures

Name	Time	Method
improvement of symptoms	at Month 2	percentage of patients with symptom change on the PGI-I scale (score 1, 2, or 3)

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Bron, France