Clinical trial NCT03911778: Evolution of Symptoms After Sacrospinofixation With Posterior Isthmic Band
Official title: Prospective Study of the Evolution of Symptoms After Sacrospinofixation With Posterior Isthmic Band
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Apical Prolapse
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with apical symptomatic prolapse ≥ II in the Pelvic Organ Prolapse Quantification (POP-Q) classification and for whom sacrospinofixation with posterior isthmic Bilateral Sacrospinous Colposuspension (BSC) Mesh is planned

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Improvement of symptoms
timeFrame: 6 weeks postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de gynecologie Hôpital Femme mère enfant
Study officials:
affiliation: Hospices Civils de Lyon, Hôpital Femme Mère Enfant
name: Gautier CHENE, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: