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Completed

NCT Number: NCT03911778

Evolution of Symptoms After Sacrospinofixation With Posterior Isthmic Band

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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Key information

Conditions

Apical Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Service de gynecologie Hôpital Femme mère enfant

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Improvement of symptoms

Other

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

Primary outcomes

  1. Improvement of symptoms

    Time frame: 6 weeks postoperatively

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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: SPIP

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 11, 2019
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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