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Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse

31. januar 2017 opdateret af: Centre Hospitalier Universitaire de Nīmes

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

121

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Châtellerault Cedex, Frankrig, 86106
        • CH Camille Guérin
      • Clermont Ferrand, Frankrig, 63003
        • CHU de Clermont Ferrand - Hopital Estaing
      • Dunkerque, Frankrig, 59385
        • CH de Dunkerque
      • Gonesse, Frankrig, 95500
        • CH de Gonesse
      • Lille Cedex, Frankrig, 59037
        • CHRU de Lille - Hôpital Jeanne de Flandre
      • Lyon Cedex 4, Frankrig, 69317
        • CHRU de Lyon - Hôpital de la Croix Rousse
      • Marseille Cedex 5, Frankrig, 13385
        • APHM - Hôpital de la Conception
      • Montpellier, Frankrig, 34070
        • Clinique Beau Soleil
      • Montpellier, Frankrig, 34295
        • CHU de Montpellier - Hôpital Lapeyronie
      • Nîmes Cedex 09, Frankrig, 30029
        • CHU de Nimes - Hopital Universitaire Caremeau
      • Orange, Frankrig, 84106
        • CH Louis Giorgi
      • Poitiers, Frankrig, 86021
        • CHU De Poitiers
      • Suresnes, Frankrig, 92150
        • Hôpital Foch

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: UpholdTM LITE placement
Uphold TM LITE mesh is used for the surgical correction of pelvic organ prolapse.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Apical anatomical success
Tidsramme: 12 months
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
Tidsramme: 12 months
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
Tidsramme: baseline to 12 lines
baseline to 12 lines

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Efterforskere

  • Ledende efterforsker: Renaud de Tayrac, MD PhD, Centre Hospitalier Universitaire de Nīmes

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2012

Primær færdiggørelse (Faktiske)

15. juli 2016

Studieafslutning (Faktiske)

15. juli 2016

Datoer for studieregistrering

Først indsendt

19. marts 2012

Først indsendt, der opfyldte QC-kriterier

20. marts 2012

Først opslået (Skøn)

21. marts 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

1. februar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. januar 2017

Sidst verificeret

1. januar 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LOCAL/2011/RdeT-04
  • 2011-A01705-36 (Anden identifikator: RCB number)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Prolaps af bækkenorganer

Kliniske forsøg med UpholdTM LITE placement

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in India

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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