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Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse

31. januar 2017 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

121

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

50 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: UpholdTM LITE placement
Uphold TM LITE mesh is used for the surgical correction of pelvic organ prolapse.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2012

Primær fullføring (Faktiske)

15. juli 2016

Studiet fullført (Faktiske)

15. juli 2016

Datoer for studieregistrering

Først innsendt

19. mars 2012

Først innsendt som oppfylte QC-kriteriene

20. mars 2012

Først lagt ut (Anslag)

21. mars 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

1. februar 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. januar 2017

Sist bekreftet

1. januar 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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