Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse (NCT01559168) | Clinical Trial Compass
CompletedNot Applicable
Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse
France121 participantsStarted 2012-10
Plain-language summary
The primary objective of this study is to evaluate the efficacy of the UpholdTM LITE mesh over a 12 month follow up period, using a composite outcome including a good anatomical correction for both anterior and apical compartments (stage 0 or 1), no prolapse (bulge) symptoms (answer "no" at question 3 of the PFDI-20) and no reintervention for recurrent prolapse of the anterior or apical compartment.
Who can participate
Age range50 Years
SexFEMALE
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Inclusion Criteria:
* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 12 months of follow-up
* Patients with symptoms and altered quality of life in relation to uterine or post-hysterectomy vault prolapse
* Patients who are receiving the UpholdTM LITE mesh Kit
* Female patients \>= years who have no desire of future pregnancy
* Diagnosed with pelvic organ prolapse and \>= ICS POP-Q Stage 2 Symptomatic Prolapse apical compartment (uterine or vault), associated with ICS POP-Q Stage 2 or 3 Symptomatic Prolapse anterior compartment (point Ba \>= -1
* Patients willing to complete quality of life questionnaire at baseline (pre-procedure) and at 6 weeks, 6 and 12 months post-procedure
Exclusion Criteria:
* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* Patients who are not receiving the UpHoldTM LITE mesh Kit
* Patients \< 50 years
* Patients qho, according to the clinical judgment of the investigator, are not suitable for this study
* Patients who are considering future pregnancies
* Patients whose pelvic organ prolapse is a \<= 1 ICS Stage
* Patients requiring Posterior …