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Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse

Primary Purpose

Pelvic Organ Prolapse

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
UpholdTM LITE placement
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • CH Camille Guérin
  • CHU de Clermont Ferrand - Hôpital Estaing
  • CH de Dunkerque
  • CH de Gonesse
  • CHRU de Lille - Hôpital Jeanne de Flandre
  • CHRU de Lyon - Hôpital de la Croix Rousse
  • APHM - Hôpital de la Conception
  • Clinique Beau Soleil
  • CHU de Montpellier - Hôpital Lapeyronie
  • CHU de Nîmes - Hôpital Universitaire Carémeau
  • CH Louis Giorgi
  • CHU de Poitiers
  • Hôpital Foch

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prolapse patients recieving UpHold LITE

Arm Description

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.

Outcomes

Primary Outcome Measures

Apical anatomical success
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
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

Secondary Outcome Measures

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)
Apical anatomical success
Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C <= stage 1 per POP-Q scoreing (ICS)
Apical anatomical success
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
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
Change from baseline in PFDI-20 scores
Change from baseline in PFIQ-7 scores
Change from baseline in PFIQ-7 scores
Change from baseline in PFIQ-7 scores
Change from baseline in PISQ-12 scores
Change from baseline in PISQ-12 scores
length of hospital stay (days)
Number of days necessary for return to normal activities
Visual analog scale for post-operative pain
score ranging from 0.0 to 10.0
Visual analog scale for post-operative pain
score ranging from 0.0 to 10.0
Visual analog scale for post-operative pain
score ranging from 0.0 to 10.0
Visual analog scale for post-operative pain
score ranging from 0.0 to 10.0
Mesh related morbidity
Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)
Mesh related morbidity
Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)
Mesh related morbidity
Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)
Mesh related morbidity
Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)
Mesh contraction (cm)
Mesh contraction as determined by ultrasound measurement (cm)
Mesh contraction (cm)
Mesh contraction as determined by ultrasound measurement (cm)
Mesh contraction (cm)
Mesh contraction as determined by ultrasound measurement (cm)
Patient satisfaction (PGI index) score
Patient satisfaction (PGI index) score
Patient satisfaction (PGI index) score

Full Information

First Posted
March 19, 2012
Last Updated
January 31, 2017
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT01559168
Brief Title
Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse
Official Title
Clinical Evaluation of the Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse: a Prospective, Multicenter Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
July 15, 2016 (Actual)
Study Completion Date
July 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prolapse patients recieving UpHold LITE
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
UpholdTM LITE placement
Intervention Description
Uphold TM LITE mesh is used for the surgical correction of pelvic organ prolapse.
Primary Outcome Measure Information:
Title
Apical anatomical success
Description
Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C <= stage 1 per POP-Q scoreing (ICS)
Time Frame
12 months
Title
Anterior vaginal wall anatomical success
Description
Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba < = stage 1 per POP-Q scoring (ICS)
Time Frame
12 months
Title
Change from baseline in PFDI-20 scores
Time Frame
baseline to 12 lines
Secondary Outcome Measure Information:
Title
Anterior vaginal wall anatomical success
Description
Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba < = stage 1 per POP-Q scoring (ICS)
Time Frame
6 months
Title
Apical anatomical success
Description
Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C <= stage 1 per POP-Q scoreing (ICS)
Time Frame
6 weeks
Title
Apical anatomical success
Description
Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C <= stage 1 per POP-Q scoreing (ICS)
Time Frame
6 months
Title
Anterior vaginal wall anatomical success
Description
Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba < = stage 1 per POP-Q scoring (ICS)
Time Frame
6 weeks
Title
Change from baseline in PFDI-20 scores
Time Frame
baseline to 6 weeks
Title
Change from baseline in PFDI-20 scores
Time Frame
baseline to 6 months
Title
Change from baseline in PFIQ-7 scores
Time Frame
baseline to 6 weeks
Title
Change from baseline in PFIQ-7 scores
Time Frame
baseline to 6 months
Title
Change from baseline in PFIQ-7 scores
Time Frame
baseline to 12 months
Title
Change from baseline in PISQ-12 scores
Time Frame
baseline to 6 months
Title
Change from baseline in PISQ-12 scores
Time Frame
baseline to 12 months
Title
length of hospital stay (days)
Time Frame
6 weeks
Title
Number of days necessary for return to normal activities
Time Frame
6 weeks
Title
Visual analog scale for post-operative pain
Description
score ranging from 0.0 to 10.0
Time Frame
Day 1
Title
Visual analog scale for post-operative pain
Description
score ranging from 0.0 to 10.0
Time Frame
6 weeks
Title
Visual analog scale for post-operative pain
Description
score ranging from 0.0 to 10.0
Time Frame
6 months
Title
Visual analog scale for post-operative pain
Description
score ranging from 0.0 to 10.0
Time Frame
12 months
Title
Mesh related morbidity
Description
Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)
Time Frame
Day 1
Title
Mesh related morbidity
Description
Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)
Time Frame
6 weeks
Title
Mesh related morbidity
Description
Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)
Time Frame
6 months
Title
Mesh related morbidity
Description
Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)
Time Frame
12 months
Title
Mesh contraction (cm)
Description
Mesh contraction as determined by ultrasound measurement (cm)
Time Frame
6 weeks
Title
Mesh contraction (cm)
Description
Mesh contraction as determined by ultrasound measurement (cm)
Time Frame
6 months
Title
Mesh contraction (cm)
Description
Mesh contraction as determined by ultrasound measurement (cm)
Time Frame
12 months
Title
Patient satisfaction (PGI index) score
Time Frame
6 weeks
Title
Patient satisfaction (PGI index) score
Time Frame
6 months
Title
Patient satisfaction (PGI index) score
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renaud de Tayrac, MD PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Camille Guérin
City
Châtellerault Cedex
ZIP/Postal Code
86106
Country
France
Facility Name
CHU de Clermont Ferrand - Hôpital Estaing
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
CH de Dunkerque
City
Dunkerque
ZIP/Postal Code
59385
Country
France
Facility Name
CH de Gonesse
City
Gonesse
ZIP/Postal Code
95500
Country
France
Facility Name
CHRU de Lille - Hôpital Jeanne de Flandre
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
CHRU de Lyon - Hôpital de la Croix Rousse
City
Lyon Cedex 4
ZIP/Postal Code
69317
Country
France
Facility Name
APHM - Hôpital de la Conception
City
Marseille Cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
Clinique Beau Soleil
City
Montpellier
ZIP/Postal Code
34070
Country
France
Facility Name
CHU de Montpellier - Hôpital Lapeyronie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 09
ZIP/Postal Code
30029
Country
France
Facility Name
CH Louis Giorgi
City
Orange
ZIP/Postal Code
84106
Country
France
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Hôpital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
31359498
Citation
Allegre L, Debodinance P, Demattei C, Fabbro Peray P, Cayrac M, Fritel X, Courtieu C, Fatton B, de Tayrac R. Clinical evaluation of the Uphold LITE mesh for the surgical treatment of anterior and apical prolapse: A prospective, multicentre trial. Neurourol Urodyn. 2019 Nov;38(8):2242-2249. doi: 10.1002/nau.24125. Epub 2019 Jul 29.
Results Reference
derived

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Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse

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