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.
Secondary objectives include the evaluation of the following: * Change from baseline of POP-Q scoring at 6 weeks, 6 months and 12 months post procedure, including evolution of treated or non-treated posterior compartments. * The proportion of patients with anatomical prolapse (C/D), but who are asymptomatic. * Change from baseline of mean quality-of-life scores. * Evaluation of mesh properties from procedure date through study period. * Peri-operative and post-treatment pain score assessment comparing the various anesthesia regimes used (Visual Analog Scale). * Assessment of patient subjective outcomes for overall treatment effects and satisfaction. * Objective evaluation of mesh shrinkage by standardized ultrasound measurements.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
121
Uphold TM LITE mesh is used for the surgical correction of pelvic organ prolapse.
CH Camille Guérin
Châtellerault, France
CHU de Clermont Ferrand - Hôpital Estaing
Clermont-Ferrand, France
CH de Dunkerque
Dunkirk, France
Apical anatomical success
Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C \<= stage 1 per POP-Q scoreing (ICS)
Time frame: 12 months
Anterior vaginal wall anatomical success
Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba \< = stage 1 per POP-Q scoring (ICS)
Time frame: 12 months
Change from baseline in PFDI-20 scores
Time frame: baseline to 12 lines
Anterior vaginal wall anatomical success
Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba \< = stage 1 per POP-Q scoring (ICS)
Time frame: 6 months
Apical anatomical success
Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C \<= stage 1 per POP-Q scoreing (ICS)
Time frame: 6 weeks
Apical anatomical success
Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C \<= stage 1 per POP-Q scoreing (ICS)
Time frame: 6 months
Anterior vaginal wall anatomical success
Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba \< = stage 1 per POP-Q scoring (ICS)
Time frame: 6 weeks
Change from baseline in PFDI-20 scores
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CH de Gonesse
Gonesse, France
CHRU de Lille - Hôpital Jeanne de Flandre
Lille, France
CHRU de Lyon - Hôpital de la Croix Rousse
Lyon, France
APHM - Hôpital de la Conception
Marseille, France
Clinique Beau Soleil
Montpellier, France
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France
...and 3 more locations
Time frame: baseline to 6 weeks
Change from baseline in PFDI-20 scores
Time frame: baseline to 6 months
Change from baseline in PFIQ-7 scores
Time frame: baseline to 6 weeks
Change from baseline in PFIQ-7 scores
Time frame: baseline to 6 months
Change from baseline in PFIQ-7 scores
Time frame: baseline to 12 months
Change from baseline in PISQ-12 scores
Time frame: baseline to 6 months
Change from baseline in PISQ-12 scores
Time frame: baseline to 12 months
length of hospital stay (days)
Time frame: 6 weeks
Number of days necessary for return to normal activities
Time frame: 6 weeks
Visual analog scale for post-operative pain
score ranging from 0.0 to 10.0
Time frame: Day 1
Visual analog scale for post-operative pain
score ranging from 0.0 to 10.0
Time frame: 6 weeks
Visual analog scale for post-operative pain
score ranging from 0.0 to 10.0
Time frame: 6 months
Visual analog scale for post-operative pain
score ranging from 0.0 to 10.0
Time frame: 12 months
Mesh related morbidity
Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)
Time frame: Day 1
Mesh related morbidity
Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)
Time frame: 6 weeks
Mesh related morbidity
Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)
Time frame: 6 months
Mesh related morbidity
Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)
Time frame: 12 months
Mesh contraction (cm)
Mesh contraction as determined by ultrasound measurement (cm)
Time frame: 6 weeks
Mesh contraction (cm)
Mesh contraction as determined by ultrasound measurement (cm)
Time frame: 6 months
Mesh contraction (cm)
Mesh contraction as determined by ultrasound measurement (cm)
Time frame: 12 months
Patient satisfaction (PGI index) score
Time frame: 6 weeks
Patient satisfaction (PGI index) score
Time frame: 6 months
Patient satisfaction (PGI index) score
Time frame: 12 months