Evolution of Symptoms After Sacrospinofixation With Posterior Isthmic Band

Apical Prolapse Clinical Trial

— SPIP  

Official title:

Prospective Study of the Evolution of Symptoms After Sacrospinofixation With Posterior Isthmic Band

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03911778
• Other study ID #: 69HCL19_0256
• Secondary ID: 2019-A01044-53
• Status: Completed
• Start date: September 2, 2019
• Est. completion date: November 15, 2023

Study information

• Verified date: January 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 15, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apical Prolapse
• Prolapse

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	Service de gynecologie Hôpital Femme mère enfant	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 improvement of their symptoms on the Patient Global Impression of Improvement Index (PGI-I) scale (score 1, 2, or 3)	6 weeks postoperatively