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A Multi Center Study to Validate a Condition-specific Measure of Sexual Health in Women With Pelvic Floor Disorders

10. december 2015 opdateret af: Rebecca G Rogers, International Urogynecological Society

Study Aims:

  1. To validate a new measure of sexual function and activity in women with PFDs;
  2. To establish the responsiveness to change of the new measure.

The investigators hypothesis is that the investigators can create a new questionnaire that accurately measures sexual health in women with pelvic floor disorders that improves on the already published questionnaires.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

600 women presenting for care to urogynecology clinics in the United States and England will be recruited to participate. They will give data regarding their physical exam, including measurements by the Pelvic Organ Prolapse Quantification exam and medical and surgical history. In addition, they will complete validated questionnaires including the Incontinence Severity Index, the Pelvic Floor Distress Inventory (short form) and question # 35 from the Epidemiology of Prolapse and Incontinence Questionnaire. All women will also complete two sexual health questionnaires; the Female Sexual Function Index and the Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire (Revised). Women will receive standard care for their pelvic floor disorders. They will then be recontacted to repeat the same set of questionnaires to determine the responsiveness of the new measure. Reliability of the questionnaire will be measured by having a subset of women complete the questionnaire twice; a factor analysis will be performed to determine the underlying factor structure. Responses to the other QOL measures will be compared to those to the new instrument to establish validity.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

877

Kontakter og lokationer

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

Studiesteder

  • Det Forenede Kongerige
      • London, Det Forenede Kongerige
        • Chelsea and Westminster Hospital
      • Manchester, Det Forenede Kongerige
        • The Warrell Unit, Whitworth Park
      • Middlesex, Det Forenede Kongerige
        • Northwick Park and St Marks Hospital
      • Sheffield, Det Forenede Kongerige
        • Royal Hallamshire Hospital
      • Surrey, Det Forenede Kongerige
        • Mayday University Hospital
  • Forenede Stater
    • California
      • San Diego, California, Forenede Stater, 92037
        • UCSD Women's Pelvic Medicine Center
    • Illinois
      • Evanston, Illinois, Forenede Stater, 60611
        • Northwestern University Feinburg School of Medicine
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55441
        • MetroUrology
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87131
        • University of New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87131
        • Women's Pelvic Speciality Care PC
    • Ohio
      • Cincinatti, Ohio, Forenede Stater, 45069
        • Center for Female Sexual Health
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Lerner College of Medicine
      • Zanesville, Ohio, Forenede Stater, 52803
        • Genesis Health System
    • Pennsylvania
      • Danville, Pennsylvania, Forenede Stater, 17882
        • Geisinger Health Systems

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 til 100 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Goal to enroll approximately 800 women so that 600 surveys are available for evaluation of the sexual health of women with pelvic floor disorders presenting for urogynecological care in the United States or England

Beskrivelse

Inclusion Criteria:

  • Inclusion criteria for patients include age over 18 years.
  • Not pregnant.
  • Able to read/write and understand English.
  • And, because this is a project to validate a measure of female sexual function, all subjects will be women.
  • All women will be seeking care for PFD including urinary and anal incontinence and POP. Since data collection will primarily be by mail
  • Women must have a stable and current address.

Exclusion Criteria:

  • Women under the age of 18.
  • Are pregnant or who are unable to read/write or understand English will not be eligible for participation.
  • In addition, women with a diagnosis of vulvodynia, painful bladder syndrome, or chronic pelvic pain (defined as pelvic pain for greater than 6 months) as determined by the consenting physician will be excluded.
  • Since this is a study to evaluate both sexual activity status as well as sexual function, women need not be sexually active to participate.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Survey of Women PFDs
Women with PFDs
Andet: Survey
This is a study to develop a survey for sexual health in women with pelvic floor dysfunction

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
The primary outcome measure for this study is the creation of a valid and reliable new measure of sexual health in women with pelvic floor disorders.
Tidsramme: 3-5 months
3-5 months

Samarbejdspartnere og efterforskere

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

Sponsor

International Urogynecological Society

Efterforskere

  • Ledende efterforsker: Rebecca G Rogers, MD, University of New Mexico Health Sciences Center

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. august 2009

Primær færdiggørelse (Faktiske)

1. august 2012

Studieafslutning (Faktiske)

1. august 2012

Datoer for studieregistrering

Først indsendt

4. august 2009

Først indsendt, der opfyldte QC-kriterier

5. august 2009

Først opslået (Skøn)

6. august 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. december 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. december 2015

Sidst verificeret

1. december 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IUGA -1 - 09

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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