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GYNECARE PROSIMA* Pelvic Floor Repair System for Pelvic Organ Prolapse

5. mai 2014 oppdatert av: Ethicon, Inc.

A Prospective, Multi-centre Study to Evaluate the Clinical Performance of the GYNECARE PROSIMA* Pelvic Floor Repair System as a Procedure for Pelvic Organ Prolapse

The purpose of this study is to is to evaluate the success of the GYNECARE PROSIMA* system in women with symptoms for pelvic organ prolapse (POP) requiring surgical correction of POP.

(*TRADEMARK)

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The GYNECARE PROSIMA* system provides a simplified mesh repair, avoiding the need for dissection outside the pelvic cavity.

Studietype

Observasjonsmessig

Registrering (Faktiske)

150

Kontakter og plasseringer

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

Studiesteder

  • Australia
      • Melbourne, Australia, 3053
        • Royal Women's Hospital
  • Forente stater
    • Florida
      • Naples, Florida, Forente stater, 34102
        • Specialists in Urology
    • Michigan
      • Dearborn, Michigan, Forente stater, 48124
        • Female Pelvic Medicine and Urogynecology Institute of Michigan
      • Grand Rapids, Michigan, Forente stater, 49506
        • Female Pelvic Medicine & Urogynecology
    • Pennsylvania
      • Allentown, Pennsylvania, Forente stater, 18104
        • The Institute for Female Pelvic Medicine & Reconstructive Surgery
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • Magee Women's Hospital of the Universtiy of Pittsburgh
  • Storbritannia
      • Cambridge, Storbritannia, CB2 0QQ
        • Addenbrookes Hospital
      • Hampshire, Storbritannia, RG24 9NA
        • North Hampshire Hospital
      • Manchester, Storbritannia, M13 0JH
        • St. Mary's Hospital
  • Tyskland
      • Halle, Tyskland, 06097
        • Bereich Urogynakologie
      • Tubingen, Tyskland, 72076
        • Universitatsklinik Tubingen

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Women over 18 with symptomatic pelvic organ prolapse of ICS POP-Q Stage II or III, suitable for surgical repair

Beskrivelse

Inclusion Criteria:

  • Candidates with symptomatic pelvic organ prolapse of ICS POP-Q Stage II or III, suitable for surgical repair. Vaginal hysterectomy, perineal repair and/or mid urethral sling procedures for incontinence may be performed concurrently.
  • Age ≥ 18 years.
  • Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires, and documents this agreement by signing the Ethics Committee / IRB approved informed consent.

Exclusion Criteria:

  • Additional surgical intervention concurrent to the PROSIMA procedure (e.g. sacrocolpopexy, paravaginal repair, tubal sterilisation).
  • Previous repair of pelvic organ prolapse involving insertion of mesh.
  • Previous hysterectomy within 6 months of scheduled surgery.
  • Experimental drug or experimental medical device within 3 months prior to the planned procedure.
  • Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.
  • Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery.
  • History of chemotherapy or pelvic radiation therapy.
  • Systemic disease known to affect bladder or bowel function (e.g. Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury or trauma).
  • Current evaluation or treatment for chronic pelvic pain (e.g. interstitial cystitis, endometriosis, coccydynia, vulvodynia).
  • Nursing or pregnant or intends future pregnancy.
  • In the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
1
Prosima Pelvic Floor Repair System
Enhet: GYNECARE PROSIMA* Pelvic Floor Repair System
procedure for pelvic organ prolapse
Andre navn:
  • mesh pelvic floor repari

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Success based on overall POP-Q score at 12 months post-procedure.
Tidsramme: 12-months
Success is determined by achievement of an overall POP-Q score of ICS Stage ≤1, without further re-intervention for POP.
12-months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Smertescore målt ved hjelp av Visual Analog Scale (VAS).
Tidsramme: 24 timer etter operasjonen og ved 3-4 ukers besøk
24 timer etter operasjonen og ved 3-4 ukers besøk
Success based on overall POP-Q score at 24 months post-procedure.
Tidsramme: 24 months
Success is determined by achievement of an overall POP-Q score of ICS Stage ≤1, without further re-intervention for POP
24 months
Success based on treated compartment ICS POP-Q stage
Tidsramme: 12 months
Success will be determined by achievement of treated compartment POP-Q score of ICS Stage ≤1, without further re-intervention for POP.
12 months
Success based on treated compartment ICS POP-Q stage
Tidsramme: 24 months
Success will be determined by achievement of treated compartment POP-Q score of ICS Stage ≤1, without further re-intervention for POP.
24 months
Success defined as the leading edge within the hymen
Tidsramme: 12 months
Success defined as the leading edge within the hymen (i.e. all POP-Q values to be less than 0, without further re-intervention for POP)
12 months
Success defined as the leading edge within the hymen
Tidsramme: 24 months
Success defined as the leading edge within the hymen (i.e. all POP-Q values to be less than 0, without further re-intervention for POP)
24 months
Mean PFDI-20 score
Tidsramme: 12 months
12 months
Mean PFDI-20 score
Tidsramme: 24 months
24 months
Mean change from baseline in PFDI-20 scores
Tidsramme: 24 months
24 months
Mean change from baseline in PFDI-20 scores
Tidsramme: 12 months
12 months
Mean POPDI score
Tidsramme: 12 months
POPDI is a sub score of PFDI-20
12 months
Mean POPDI score
Tidsramme: 24 months
POPDI is a sub score of PFDI-20
24 months
Mean change from baseline in POPDI score
Tidsramme: 12 months
POPDI is a sub scores of PFDI-20
12 months
Mean change from baseline in POPDI score
Tidsramme: 24 months
POPDI is a sub score of PFDI-20
24 months
Mean CRADI score
Tidsramme: 12 months
CRADI is a sub score of PFDI-20
12 months
Mean CRADI score
Tidsramme: 24 months
CRADI is a sub score of PFDI-20
24 months
Mean change from baseline in CRADI score
Tidsramme: 12 months
CRADI is a sub score of PFDI-20
12 months
Mean change from baseline in CRADI score
Tidsramme: 24 months
CRADI is a sub score of PFDI-20
24 months
Mean UDI score
Tidsramme: 12 months
UDI is a sub score of PFDI-20
12 months
Mean UDI score
Tidsramme: 24 months
UDI is a sub score of PFDI-20
24 months
Mean change from baseline in UDI score
Tidsramme: 12 months
UDI is a sub score of PFDI-20
12 months
Mean change from baseline in UDI score
Tidsramme: 24 months
UDI is a sub score of PFDI-20
24 months
EuroQol (EQ-5D health state) change from baseline
Tidsramme: 12 months
12 months
EuroQol (EQ-5D health state) change from baseline
Tidsramme: 24 months
24 months
Mean PFIQ-7 score
Tidsramme: 12 months
12 months
Mean PFIQ-7 score
Tidsramme: 24 months
24 months
Mean change from baseline in PFIQ-7 score
Tidsramme: 12 months
12 months
Mean change from baseline in PFIQ-7 score
Tidsramme: 24 months
24 months
Mean POPIQ score
Tidsramme: 12 months
POPIQ is a sub-score of PFIQ-7
12 months
Mean POPIQ score
Tidsramme: 24 months
POPIQ is a sub-score of PFIQ-7
24 months
Mean change from baseline in POPIQ score
Tidsramme: 12 months
POPIQ is a sub-score of PFIQ-7
12 months
Mean change from baseline in POPIQ score
Tidsramme: 24 months
POPIQ is a sub-score of PFIQ-7
24 months
Mean CRAIQ score
Tidsramme: 12 months
CRAIQ is a sub-score of PFIQ-7
12 months
Mean CRAIQ score
Tidsramme: 24 months
CRAIQ is a sub-score of PFIQ-7
24 months
Mean change from baseline in CRAIQ score
Tidsramme: 12 months
CRAIQ is a sub-score of PFIQ-7
12 months
Mean change from baseline in CRAIQ score
Tidsramme: 24 months
CRAIQ is a sub-score of PFIQ-7
24 months
Mean UIQ score
Tidsramme: 12 months
UIQ is a sub-score of PFIQ-7
12 months
Mean UIQ score
Tidsramme: 24 months
UIQ is a sub-score of PFIQ-7
24 months
Mean change from baseline in UIQ score
Tidsramme: 12 months
UIQ is a sub-score of PFIQ-7
12 months
Mean change from baseline in UIQ score
Tidsramme: 24 months
UIQ is a sub-score of PFIQ-7
24 months
Mean PISQ-12 score
Tidsramme: 12 months
In subjects sexually active at baseline, assessment of sexual function
12 months
Mean PISQ-12 score
Tidsramme: 24 months
In subjects sexually active at baseline, assessment of sexual function
24 months
Mean change from baseline in PISQ-12 score
Tidsramme: 12 months
In subjects sexually active at baseline, assessment of sexual function
12 months
Mean change from baseline in PISQ-12 score
Tidsramme: 24 months
In subjects sexually active at baseline, assessment of sexual function
24 months
Incidence of new onset dyspareunia, resolution or continuance of pre-existing dyspareunia
Tidsramme: ongoing
ongoing
Length of procedure
Tidsramme: perioperative
From time to first incision to time of last suture used to secure VSD
perioperative
Discomfort of balloon removal, measured using VAS at time of removal.
Tidsramme: 24 hrs post-surgical
24 hrs post-surgical
Subject perception of VSD: Awareness
Tidsramme: 3-4 week visit
Measured by visual analogue scale
3-4 week visit
Subject perception of VSD: Discomfort
Tidsramme: 3-4 week visit
Measured by visual analogue scale
3-4 week visit
Subject perception of VSD: Acceptability of discharge
Tidsramme: 3-4 week visit
Measured by visual analogue scale
3-4 week visit
Subject global impression
Tidsramme: 12 month visit
assessed on a 5 point Likert scale
12 month visit
Subject global impression
Tidsramme: 24 month visit
assessed on a 5 point Likert scale
24 month visit

Samarbeidspartnere og etterforskere

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

Sponsor

Ethicon, Inc.

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. juni 2007

Primær fullføring (Faktiske)

1. oktober 2008

Studiet fullført (Faktiske)

1. juni 2010

Datoer for studieregistrering

Først innsendt

24. august 2007

Først innsendt som oppfylte QC-kriteriene

24. august 2007

Først lagt ut (Anslag)

27. august 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

6. mai 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. mai 2014

Sist bekreftet

1. mai 2014

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 300-06-005

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