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Search / Trial NCT03200327

Comparison of Anterior Vaginal Sacrospinofixation With Laparoscopic Promontofixation for the Treatment of Anterior and Apical Genitourinary Prolapse

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · Jun 26, 2017

Trial Information

Current as of May 01, 2025

Terminated

Keywords

ClinConnect Summary

No description provided

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • The patient must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan
  • Patient must be available for 12 month follow-up
  • Patient is ≥50 and \<80 years old
  • Patient has pelvic prolapse stage 2 or above according to international POP-Q score, concerning the anterior and apical compartments, justifying surgical treatment
  • Patients not having preoperational stress urinary incontinence or having mild stress urinary incontinence not causing significant functional problems (response \<2 to question 17 of PFDI-20 questionnaire). It is possible that patients with hidden stress urinary incontinence will be recruited
  • Exclusion Criteria:
  • The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
  • The patient is under safeguard of justice or state guardianship
  • The subject refuses to sign the consent
  • Patient with communication issues preventing comprehension of information and administration of questionnaires
  • Pelvic prolapse not affect anterior and apical compartments, regardless of stage
  • Patient with preoperative dyspareunia (patients with mild sexual discomfort related to prolapse may be included
  • Patient presents with preoperative stress urinary incontinence responsible of significant functional incapacity (response ≥2 to question 17 of PFDI-20 questionnaire).
  • Indication for concomitant suburethral sling
  • Patient with previous history of surgery for stress urinary incontinence
  • Indication of concomitant perineorrhaphy surgery with or without myorrhaphy (in both groups).
  • Contra-indication for general anesthetic
  • Current urinary infection
  • Current vaginal infection

About Centre Hospitalier Universitaire De Nīmes

The Centre Hospitalier Universitaire de Nîmes (CHU Nîmes) is a leading academic medical center located in Nîmes, France, dedicated to advancing healthcare through innovative clinical research and patient care. As a prominent sponsor of clinical trials, CHU Nîmes collaborates with a multidisciplinary team of healthcare professionals and researchers to conduct rigorous studies aimed at improving treatment outcomes and enhancing medical knowledge across various specialties. With a strong commitment to ethical standards and patient safety, CHU Nîmes fosters a research environment that encourages scientific excellence and contributes to the development of new therapies and healthcare solutions.

Locations

Montpellier, , France

Clermont Ferrand, , France

Lille, , France

Montpellier, , France

Nîmes, , France

Clermont Ferrand, Auvergne, France

Lyon, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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