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Evolution of Symptoms After Anterior Sacrospinofixation by Autologous Tissues

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04270188
Acronym
SANTAU
Enrollment
66
Registered
2020-02-17
Start date
2020-07-21
Completion date
2025-10-28
Last updated
2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

Keywords

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

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.

Interventions

OTHERevolution of patient symptoms

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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

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

Countries

France

Contacts

PRINCIPAL_INVESTIGATORGéry LAMBLIN, MD

Hospices Civils de Lyon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026