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Evolution of Symptoms After Sacrospinofixation With Posterior Isthmic Band

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03911778
Acronym
SPIP
Enrollment
33
Registered
2019-04-11
Start date
2019-09-02
Completion date
2023-11-15
Last updated
2024-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apical Prolapse

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.

Interventions

OTHERImprovement 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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Improvement of symptoms6 weeks postoperativelyPercentage of patients with improvement of their symptoms on the Patient Global Impression of Improvement Index (PGI-I) scale (score 1, 2, or 3)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026