Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse

This study is currently recruiting participants. (see Contacts and Locations)
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: April 24, 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Lille - Hôpital Jeanne de Flandre Recruiting
Lille Cedex, France, 59037
Sub-Investigator: Michel Cosson, MD, PhD         
Sub-Investigator: Géraldine Giraudet, 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         
CHU de Montpellier - Hôpital Lapeyronie Not yet recruiting
Montpellier, France, 34295
Sub-Investigator: Mélanie Cayrac, MD         
Clinique Beau Soleil Not yet recruiting
Montpellier, France, 34070
Sub-Investigator: Christophe Courtieu, MD         
Sub-Investigator: Laure Panel, 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: April 24, 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:
Pelvic Organ Prolapse
Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 20, 2014