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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Montpellier, , France
Clermont Ferrand, , France
Lille, , France
Montpellier, , France
Nîmes, , France
Clermont Ferrand, Auvergne, France
Lyon, , France
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials