Comparison of Anterior Vaginal Sacrospinofixation With Laparoscopic Promontofixation for the Trea… (NCT03200327) | Clinical Trial Compass
TerminatedNot Applicable
Comparison of Anterior Vaginal Sacrospinofixation With Laparoscopic Promontofixation for the Treatment of Anterior and Apical Genitourinary Prolapse
Stopped: withdrawal of vaginal prosthesis from the market
France55 participantsStarted 2017-12-18
Plain-language summary
The investigators anticipate a reduced risk of post-operational de novo stress urinary incontinence following surgery for vaginal sacrospinofixation, associated with reduced costs, comparable functional and anatomical efficacy and no increase in morbidity and rate of dyspareunia with the new treatment
Who can participate
Age range50 Years – 80 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 suburethr…
What they're measuring
1
Compare the rate of de novo problematic stress urinary incontinence, operable or not, between groups response