Evolution of Symptoms After Anterior Sacrospinofixation by Autologous Tissues

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.

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hospices Civils de Lyon

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

evolution of patient symptoms

Other

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

Primary outcomes

improvement of symptoms

Time frame: at Month 2

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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Prospective Study of the Evolution of Symptoms After Anterior Sacrospinofixation by Autologous Tissues

Acronym: SANTAU

Important dates

Study start: 2020
Primary completion: 2025
Study completion: 2025
First posted: Feb 17, 2020
Registry last updated: Mar 6, 2026

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.

Published trials that share one or more normalized conditions with this study.

Completed