Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse

This study is currently recruiting participants.
Verified March 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01559168
First received: March 19, 2012
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Pelvic Organ Prolapse
Device: UpholdTM LITE placement

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse: a Prospective, Multicenter Trial

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Apical anatomical success [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline to 12 lines ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anterior vaginal wall anatomical success [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba < = stage 1 per POP-Q scoring (ICS)

  • Apical anatomical success [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C <= stage 1 per POP-Q scoreing (ICS)

  • Apical anatomical success [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline to 6 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in PFDI-20 scores [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in PFIQ-7 scores [ Time Frame: baseline to 6 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in PFIQ-7 scores [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in PFIQ-7 scores [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in PISQ-12 scores [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in PISQ-12 scores [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
  • length of hospital stay (days) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Number of days necessary for return to normal activities [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Visual analog scale for post-operative pain [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    score ranging from 0.0 to 10.0

  • Visual analog scale for post-operative pain [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    score ranging from 0.0 to 10.0

  • Visual analog scale for post-operative pain [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    score ranging from 0.0 to 10.0

  • Visual analog scale for post-operative pain [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    score ranging from 0.0 to 10.0

  • Mesh related morbidity [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)

  • Mesh related morbidity [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)

  • Mesh related morbidity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)

  • Mesh related morbidity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)

  • Mesh contraction (cm) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Mesh contraction as determined by ultrasound measurement (cm)

  • Mesh contraction (cm) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Mesh contraction as determined by ultrasound measurement (cm)

  • Mesh contraction (cm) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Mesh contraction as determined by ultrasound measurement (cm)

  • Patient satisfaction (PGI index) score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Patient satisfaction (PGI index) score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Patient satisfaction (PGI index) score [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prolapse patients recieving UpHold LITE
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
Uphold TM LITE mesh is used for the surgical correction of pelvic organ prolapse.

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.
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559168

Contacts
Contact: Renaud de Tayrac, MD PhD +33.(0)4.66.68.32.16 renaud.detayrac@chu-nimes.fr
Contact: Carey M Suehs, Ph D +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CH Camille Guérin Recruiting
Châtellerault Cedex, France, 86106
Sub-Investigator: Caroline Carlier Guerin, MD         
CHU de Clermont Ferrand - Hôpital Estaing Not yet recruiting
Clermont Ferrand, France, 63003
Sub-Investigator: Michel Canis, MD, PhD         
Sub-Investigator: Sandrine Campagne-Loiseau, MD         
Sub-Investigator: Bernard Jacquetin, MD, PhD         
Sub-Investigator: Sandra Curinier, MD         
CH de Dunkerque Recruiting
Dunkerque, France, 59385
Sub-Investigator: Philippe Debodinance, MD         
CH de Gonesse Not yet recruiting
Gonesse, France, 95500
Sub-Investigator: François Monneins, MD         
CHRU de Lyon - Hôpital de la Croix Rousse Not yet recruiting
Lyon Cedex 4, France, 69317
Sub-Investigator: Gil Dubernard, MD PhD         
APHM - Hôpital de la Conception Recruiting
Marseille Cedex 5, France, 13385
Sub-Investigator: Maxime Marcelli, MD         
Sub-Investigator: Aubert Agostini, MD PhD         
Clinique Beau Soleil Not yet recruiting
Montpellier, France, 34070
Sub-Investigator: Christophe Courtieu, MD         
Sub-Investigator: Laure Panel, MD         
CHU de Montpellier - Hôpital Lapeyronie Not yet recruiting
Montpellier, France, 34295
Sub-Investigator: Mélanie Cayrac, MD         
CHU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 09, France, 30029
Sub-Investigator: Vincent Letouzey, MD         
Principal Investigator: Renaud de Tayrac, MD PhD         
Sub-Investigator: Brigitte Fatton, MD         
CH Louis Giorgi Not yet recruiting
Orange, France, 84106
Sub-Investigator: Vincent Descheemaeker, MD         
CHU de Poitiers Recruiting
Poitiers, France, 86021
Sub-Investigator: Xavier Fritel, MD PhD         
Hôpital Foch Not yet recruiting
Suresnes, France, 92150
Sub-Investigator: Florence Cour, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Renaud de Tayrac, MD PhD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01559168     History of Changes
Other Study ID Numbers: LOCAL/2011/RdeT-04, 2011-A01705-36
Study First Received: March 19, 2012
Last Updated: March 4, 2014
Health Authority: France: Committee for the Protection of Personnes
France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 20, 2014