CYSPTO: Transobturator Repair by Vaginal Plastron

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT05741567

Collaborator

(none)

Enrollment

Location

2.6

Actual Duration (Months)

11.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The autologous vaginal route consists of repairing the genital prolapse through the vagina using the patient's tissues without a prosthesis. Vaginal prostheses are actually currently prohibited in France [1, 2].

The autologous vaginal route is the quickest surgery and it can be done under spinal anesthesia, which constitutes arguments for offering it to elderly and fragile patients. The autologous vaginal approach gives functional and subjective results similar to promontofixation [2].

There are many surgical techniques that make it difficult to assess the recurrence rate in the literature. Autologous vaginal surgery provides a good degree of satisfaction for patients despite the risk of recurrence [3].

We propose to describe the results of the transobturator cystocele repair by vaginal plastron, a technique which seems reproducible and effective to us.

Condition or Disease	Intervention/Treatment	Phase
Anterior Prolapse Surgery Using the Transobturator Repair by Vaginal Plastron	Procedure: correction of anterior prolapse

Study Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Transobturator Cystocele Repair by Vaginal Plastron

Actual Study Start Date :

Oct 13, 2022

Actual Primary Completion Date :

Nov 30, 2022

Actual Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
transobturator cystocele repair by vaginal plastron patients who underwent surgery using the transobturator repair by vaginal plastron for correction of anterior prolapse	Procedure: correction of anterior prolapse percentage of failed prolapse correction

Arm

Intervention/Treatment

transobturator cystocele repair by vaginal plastron

patients who underwent surgery using the transobturator repair by vaginal plastron for correction of anterior prolapse

Procedure: correction of anterior prolapse

percentage of failed prolapse correction

Outcome Measures

Primary Outcome Measures

failed prolapse correction [at 1 month after surgery]
percentage of failed prolapse correction

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

women over 18
patient who underwent surgery using the transobturator repair by vaginal plastron for correction of anterior prolapse requiring surgical correction of stage equal to or greater than II in the POP-Q classification
intervention between September 2020 and October 2022
person having expressed his non-opposition

Exclusion Criteria:

inability to understand the information given
person deprived of liberty
person under guardianship

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Femme Mère Enfant	Lyon	Bron	France	69500

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT05741567

Other Study ID Numbers:

22-5083
69HCL22_1180

First Posted:

Feb 23, 2023

Last Update Posted:

Feb 23, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospices Civils de Lyon

anterior prolapse

transobturator repair

vaginal plastron

Additional relevant MeSH terms:

Prolapse

Study Results

No Results Posted as of Feb 23, 2023