Pelvic Organ Prolapse
Conditions
Brief 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.
Detailed description
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.
Interventions
DEVICEUpholdTM LITE placement
Uphold TM LITE mesh is used for the surgical correction of pelvic organ prolapse.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
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 Graft procedure * Patients with known or suspected hypersensitivity to polypropylene * Patients with any pathology which ould compromise implant placement * Patients with any pathology which ould compromise implant placement as mentioned in the device instruction manual * Patients with any pathology that would limit blood supply and compromise healing * Patients with blood coagulation disorder (associated current level coagulation) * Patients with autoimmune connective tissue disease * Patients with upper urinary tract obstruction and renal insufficiency * Patients with local or systemic infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apical anatomical success | 12 months | Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C \<= stage 1 per POP-Q scoreing (ICS) |
| Anterior vaginal wall anatomical success | 12 months | Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba \< = stage 1 per POP-Q scoring (ICS) |
| Change from baseline in PFDI-20 scores | baseline to 12 lines | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in PFIQ-7 scores | baseline to 6 weeks | — |
| Change from baseline in PISQ-12 scores | baseline to 6 months | — |
| length of hospital stay (days) | 6 weeks | — |
| Number of days necessary for return to normal activities | 6 weeks | — |
| Anterior vaginal wall anatomical success | 6 months | Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba \< = stage 1 per POP-Q scoring (ICS) |
| Mesh related morbidity | Day 1 | Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia) |
| Mesh contraction (cm) | 6 weeks | Mesh contraction as determined by ultrasound measurement (cm) |
| Patient satisfaction (PGI index) score | 6 weeks | — |
| Visual analog scale for post-operative pain | Day 1 | score ranging from 0.0 to 10.0 |
| Apical anatomical success | 6 weeks | Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C \<= stage 1 per POP-Q scoreing (ICS) |
| Change from baseline in PFDI-20 scores | baseline to 6 weeks | — |
Countries
France
Outcome results
None listed