Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Evaluation of the Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse: a Prospective, Multicenter Trial

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Device: UpholdTM LITE placement


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prolapse patients recieving UpHold LITE<br>Non-pregnant female patients >= 50 years who are not considering future pregnancies, who are diagnosed with uterine or vault prolapse with ICS POP-Q score of stage 2 or greater, who are receiving the UpholdTM LITE mesh kit and who agree to be in the study. | Device: UpholdTM LITE placement<br>* Uphold TM LITE mesh is used for the surgical correction of pelvic organ prolapse.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apical anatomical success | Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C <= stage 1 per POP-Q scoreing (ICS) | 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) | 12 months | 
| Change from baseline in PFDI-20 scores |  | baseline to 12 lines | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 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) | 6 weeks | 
| Change from baseline in PFDI-20 scores |  | baseline to 6 weeks | 
| Change from baseline in PFDI-20 scores |  | baseline to 6 months | 
| Change from baseline in PFIQ-7 scores |  | baseline to 6 weeks | 
| Change from baseline in PFIQ-7 scores |  | baseline to 6 months | 
| Change from baseline in PFIQ-7 scores |  | baseline to 12 months | 
| Change from baseline in PISQ-12 scores |  | baseline to 6 months | 
| Change from baseline in PISQ-12 scores |  | baseline to 12 months | 
| length of hospital stay (days) |  | 6 weeks | 
| Number of days necessary for return to normal activities |  | 6 weeks | 
| Visual analog scale for post-operative pain | score ranging from 0.0 to 10.0 | Day 1 | 
| Visual analog scale for post-operative pain | score ranging from 0.0 to 10.0 | 6 weeks | 
| Visual analog scale for post-operative pain | score ranging from 0.0 to 10.0 | 6 months | 
| Visual analog scale for post-operative pain | score ranging from 0.0 to 10.0 | 12 months | 
| Mesh related morbidity | Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia) | Day 1 | 
| Mesh related morbidity | Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia) | 6 weeks | 
| Mesh related morbidity | Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia) | 6 months | 
| Mesh related morbidity | Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia) | 12 months | 
| Mesh contraction (cm) | Mesh contraction as determined by ultrasound measurement (cm) | 6 weeks | 
| Mesh contraction (cm) | Mesh contraction as determined by ultrasound measurement (cm) | 6 months | 
| Mesh contraction (cm) | Mesh contraction as determined by ultrasound measurement (cm) | 12 months | 
| Patient satisfaction (PGI index) score |  | 6 weeks | 
| Patient satisfaction (PGI index) score |  | 6 months | 
| Patient satisfaction (PGI index) score |  | 12 months |