Evolution of Symptoms After Anterior Sacrospinofixation by Autologous Tissues

NCT04270188 | Completed

• 2 other identifiers: 69HCL20_00772020-A00350-39
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse

Keywords

middle anterior prolapse ≥ II (POP-Q classification); anterior prolapse ≥ II (POP-Q classification)

Outcome Measures

Primary Outcomes (1)

• improvement of symptoms

  percentage of patients with symptom change on the PGI-I scale (score 1, 2, or 3)

  at Month 2

Study Arms (1)

anterior sacrospinofixation with autologous tissue

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.

Other: evolution of patient symptoms

Interventions

evolution of patient symptoms OTHER

evolution of symptoms on the PGI-I scale (score 1, 2, or 3) 2 months after surgery

anterior sacrospinofixation with autologous tissue

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients over 18 years old 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon

Bron, 69500, France

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

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

Study Officials

• Géry LAMBLIN, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 17, 2020
• Study Start: July 21, 2020
• Primary Completion: October 28, 2025
• Study Completion: October 28, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

FR (1)