Evolution of Symptoms After Sacrospinofixation With Posterior Isthmic Band

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-02

Study Completion Date

2023-11-15

Brief Summary

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Prolapse is a condition that can cause disabling pelvic, urinary or sexual function disorders and impaired quality of life.

Regarding the prolapse of the middle floor, the vaginal sacrospinofixation according to Richter is the reference technique for the suspension of the vaginal fundus. But the technique of sacrospinofixation vaginally is not without several difficulties in the short term but also in the medium and long term.

Recently, anchoring devices have been developed to limit the dissection of the sacrospinous ligament and the operative exposure by the sometimes traumatic valves.

The investigating team uses a technical variant in the form of an isthmic posterior strip of light weight and whose arms are sutured to the sacrospinous ligaments. The advantages of this isthmic strip are based on its small size, its very low basis weight and its wide mesh (improvement of tolerance) via a mini-invasive vaginal approach (thus allowing ambulatory care).

Patient functional discomfort is the main problem related to the presence of a prolapse, therefore, the researchers wish to evaluate patient feelings following the use of this isthmic band. The researchers' hypothesis is that the sacrospinofixation technique with posterior isthmic band Bilateral Sacrospinous Colposuspension (BSC) Mesh (Agency for Medical Innovations (AMI) laboratory) improves symptoms experienced by patients with mid-level prolapse.

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Detailed Description

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Conditions

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Apical Prolapse

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Sacrospinofixation

Patients with apical symptomatic prolapse ≥ II in the POP-Q classification and for whom sacrospinofixation with posterior isthmic BSC Mesh is planned

Improvement of symptoms

Intervention Type OTHER

Improvement of symptoms on the Patient Global Impression of Improvement Index (PGI-I) scale (score 1, 2, or 3) at 6 weeks postoperatively

Interventions

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Improvement of symptoms

Improvement of symptoms on the Patient Global Impression of Improvement Index (PGI-I) scale (score 1, 2, or 3) at 6 weeks postoperatively

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* women over 18
* apical prolapse requiring surgical correction of grade II or greater in the Pelvic Organ Prolapse Quantification (POP-Q) classification
* patients who wish an intervention because of the discomfort caused by prolapse
* sacrospinofixation procedure with posterior isthmic band Bilateral Sacrospinous Colposuspension (BSC) Mesh provided
* person having expressed his non-opposition

Exclusion Criteria

* apical prolapse of stage \< II in the Pelvic Organ Prolapse Quantification (POP-Q) classification, and prolapse without functional discomfort
* disorders leading to an unacceptable risk of postoperative complications sought during the interrogation of the patient (disorders of blood coagulation, disorders of the immune system, progressive diseases ....)
* reduced mobility of the lower limbs (not allowing positioning for surgery)
* pregnancy or any plans for pregnancy during the study period
* evolutionary or latent infection
* known hypersensitivity to polypropylene
* inability to understand the information given
* person deprived of liberty, under guardianship.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No