UpholdTM LITE placement
DeviceUphold TM LITE mesh is used for the surgical correction of pelvic organ prolapse.
NCT Number: NCT01559168
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.
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Notify Me50 year and older
Female
Interventional
Not applicable
CH Camille Guérin, Châtellerault, France
Secondary objectives include the evaluation of the following:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Uphold TM LITE mesh is used for the surgical correction of pelvic organ prolapse.
Time frame: 12 months
Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C <= stage 1 per POP-Q scoreing (ICS)
Time frame: 12 months
Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba < = stage 1 per POP-Q scoring (ICS)
Time frame: baseline to 12 lines
Time frame: 6 months
Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba < = stage 1 per POP-Q scoring (ICS)
Time frame: 6 weeks
Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C <= stage 1 per POP-Q scoreing (ICS)
Time frame: 6 months
Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C <= stage 1 per POP-Q scoreing (ICS)
Time frame: 6 weeks
Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba < = stage 1 per POP-Q scoring (ICS)
Time frame: baseline to 6 weeks
Time frame: baseline to 6 months
Time frame: baseline to 6 weeks
Time frame: baseline to 6 months
Time frame: baseline to 12 months
Time frame: baseline to 6 months
Time frame: baseline to 12 months
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: Day 1
score ranging from 0.0 to 10.0
Time frame: 6 weeks
score ranging from 0.0 to 10.0
Time frame: 6 months
score ranging from 0.0 to 10.0
Time frame: 12 months
score ranging from 0.0 to 10.0
Time frame: Day 1
Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)
Time frame: 6 weeks
Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)
Time frame: 6 months
Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)
Time frame: 12 months
Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)
Time frame: 6 weeks
Mesh contraction as determined by ultrasound measurement (cm)
Time frame: 6 months
Mesh contraction as determined by ultrasound measurement (cm)
Time frame: 12 months
Mesh contraction as determined by ultrasound measurement (cm)
Time frame: 6 weeks
Time frame: 6 months
Time frame: 12 months
Centre Hospitalier Universitaire de Nīmes
Other
Clinical Evaluation of the Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse: a Prospective, Multicenter Trial
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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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