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NCT04270188 Clinical Trial

Evolution of Symptoms After Anterior Sacrospinofixation by Autologous Tissues

Pelvic Organ Prolapse Clinical Trial

— SANTAU  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04270188
Other study ID # 69HCL20_0077
Secondary ID 2020-A00350-39
Status Active, not recruiting
Phase
First received
Last updated
Start date July 21, 2020
Est. completion date July 11, 2025

Study information
Verified date February 2024
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 66
Est. completion date July 11, 2025
Est. primary completion date July 11, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Hospices Civils de Lyon Bron

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary improvement of symptoms percentage of patients with symptom change on the PGI-I scale (score 1, 2, or 3) at Month 2
See also
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Recruiting NCT04172272 - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures N/A
Recruiting NCT04807920 - BOTOX® at the Time of Prolapse Surgery for OAB Phase 4
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Recruiting NCT03146195 - The 3D Reconstruction Research of Pelvic Organ Prolapse Disease N/A
Completed NCT02925585 - Vaginal Tactile Imaging for Pelvic Floor Prolapse
Not yet recruiting NCT02536001 - Prospective Randomized Study to Compare Results of Pelvic Organ Prolapse Repair With One Versus Two Vaginal Meshes N/A
Recruiting NCT02113969 - Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol N/A
Completed NCT02383199 - Polypropylene Mesh in Prolapse Surgery N/A
Terminated NCT01673360 - Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices N/A
Completed NCT01842464 - Sacro-Spinous Ligaments Anterior Apical Anchoring N/A
Withdrawn NCT01530191 - Factors Affecting Perioperative Outcomes N/A
Completed NCT01320631 - Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction N/A
Completed NCT00581412 - Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates N/A