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GYNECARE PROSIMA* Pelvic Floor Repair System for Pelvic Organ Prolapse

5. maj 2014 opdateret af: 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)

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

150

Kontakter og lokationer

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

Studiesteder

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

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
1
Prosima Pelvic Floor Repair System
Enhed: GYNECARE PROSIMA* Pelvic Floor Repair System
procedure for pelvic organ prolapse
Andre navne:
  • mesh pelvic floor repari

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
Tidsramme
Smertescore målt ved hjælp af Visual Analog Scale (VAS).
Tidsramme: 24 timer efter operationen og ved 3-4 ugers besøget
24 timer efter operationen og ved 3-4 ugers besøget
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

Samarbejdspartnere og efterforskere

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

Sponsor

Ethicon, Inc.

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. juni 2007

Primær færdiggørelse (Faktiske)

1. oktober 2008

Studieafslutning (Faktiske)

1. juni 2010

Datoer for studieregistrering

Først indsendt

24. august 2007

Først indsendt, der opfyldte QC-kriterier

24. august 2007

Først opslået (Skøn)

27. august 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. maj 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. maj 2014

Sidst verificeret

1. maj 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 300-06-005

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 .

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