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Colpopexy and Urinary Reduction Efforts (CARE) Protocol (CARE)

9. januar 2011 opdateret af: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

CARE: A Randomized Trial of Colpopexy and Urinary Reduction Efforts

Pelvic organ prolapse occurs when the muscles holding pelvic organs (e.g., the uterus or bladder) weaken and the organs fall or slide down into the vagina. Pelvic organ prolapse can be corrected with surgery. However, women who have this surgery may develop urinary incontinence. This study will determine how doctors can predict this problem and whether an additional surgical procedure at the time of prolapse surgery can prevent the development of urinary incontinence.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Many women have surgery for pelvic organ prolapse (cystocele, uterine prolapse, rectocele). Women with advanced pelvic organ prolapse may experience stress urinary incontinence following surgery to repair the prolapse. Development of incontinence is unpredictable. This study will determine which, if any, clinical tests are useful for predicting post-operative urinary incontinence. The study will also determine if a Burch urethropexy should be performed routinely or selectively at the time of sacrocolpopexy in continent women.

Women with pelvic organ prolapse who are scheduled for prolapse repair will be randomized to a Burch urethropexy group or to a control group. Women in the Burch group will undergo urethropexy at the time of prolapse repair. Assessments will include a quality of life telephone interview, urodynamic testing, and physical examination. Follow-up evaluations occur at 6 weeks, 3 months, and 1 and 2 years following surgery. Post-operative phone interviews will occur at 3 months, 6 months, and 1 and 2 years.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

322

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233-7333
        • The University of Alabama at Birmingham
    • Illinois
      • Maywood, Illinois, Forenede Stater, 60153
        • Loyola University Medical Center
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
        • University of Iowa College of Medicine
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Johns Hopkins School of Medicine
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599-7590
        • University of North Carolina at Chapel Hill
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213-3180
        • Magee-Womens Hospital
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Baylor College of Medicine

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria

  1. Eligibility for primary procedure (sacrocolpopexy)
  2. Eligibility for secondary procedure (Burch colposuspension)
  3. Stage II-IV anterior vaginal prolapse, defined as POP-Q Point Aa at -1, 0, +1, +2, or +3 cm.
  4. Negative stress incontinence screen
  5. Negative stress incontinence screen (MESA questionnaire)

Exclusion Criteria

  1. Contraindication for sacrocolpopexy or Burch colposuspension.

    • Anatomic contraindication for Burch colposuspension (i.e., Point Aa fixed at -2 or -3 cm).
    • Surgeon judgment that a contraindication to Burch colposuspension exists.
  2. Anticipated geographic relocation within the first three months after surgery (e.g., within approximately 6 months of screening).
  3. Inability to provide informed consent or to complete testing or data collection.
  4. Currently pregnant.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Abdominal Sacral Colpopexy with no Burch colposuspension
Abdominal sacral colpopexy is performed through a laparotomy approach.
Eksperimentel: Abdominal Sacral Colpopexy with Burch Colposuspension
The Burch colposuspension procedure entails the retropubic placement of at least two stitches in the vaginal tissue lateral to each side of the urethra, and suspension of these stitches from Cooper's ligament (the iliopectineal line at the superior aspect of the posterior pubic bone).
Procedure: Burch urethropexy at time of sacrocolpopexy
The Burch colposuspension procedure entails the retropubic placement of at least two stitches in the vaginal tissue lateral to each side of the urethra, and suspension of these stitches from Cooper's ligament (the iliopectineal line at the superior aspect of the posterior pubic bone).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Stress urinary continence
Tidsramme: 3 months
Patients will be categorized as stress continent or stress incontinent on the basis of symptom assessment and stress testing. The symptoms will be assessed by the stress incontinence subscale of the Pelvic Floor Distress Inventory (PFDI).
3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Complications at surgery
Tidsramme: 2 years
Complications at surgery
2 years
Occurrence of other lower urinary tract symptoms
Tidsramme: 3 mo, 2 years
measured by the urgency and obstructed voiding subscales of the PFDI
3 mo, 2 years
Other pelvic symptoms and health-related quality of life
Tidsramme: 3 mo, 2 years
includes bowel function and sexual function
3 mo, 2 years

Samarbejdspartnere og efterforskere

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

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Efterforskere

  • Ledende efterforsker: Linda Brubaker, MD, Loyola University

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

Hjælpsomme links

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. april 2002

Primær færdiggørelse (Faktiske)

1. marts 2007

Studieafslutning (Faktiske)

1. april 2007

Datoer for studieregistrering

Først indsendt

1. august 2003

Først indsendt, der opfyldte QC-kriterier

4. august 2003

Først opslået (Skøn)

5. august 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. januar 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. januar 2011

Sidst verificeret

1. oktober 2010

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • U01HD041249 (U.S. NIH-bevilling/kontrakt)
  • U10HD041268 (U.S. NIH-bevilling/kontrakt)
  • U10HD041248 (U.S. NIH-bevilling/kontrakt)
  • U10HD041250 (U.S. NIH-bevilling/kontrakt)
  • U10HD041261 (U.S. NIH-bevilling/kontrakt)
  • U10HD041263 (U.S. NIH-bevilling/kontrakt)
  • U10HD041267 (U.S. NIH-bevilling/kontrakt)
  • U10HD041269 (U.S. NIH-bevilling/kontrakt)

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 Urininkontinens, stress

Kliniske forsøg med Burch urethropexy at time of sacrocolpopexy

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