Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Mixed Incontinence: Medical Or Surgical Approach? (MIMOSA)

8. maj 2013 opdateret af: HealthCore-NERI
The purpose of this study is to compare treatment outcomes for patients with mixed urinary incontinence (MUI) for whom therapy is initiated with surgery to those for whom therapy is initiated with non-surgical treatment. Women who are bothered by symptoms of both stress and urge incontinence will be randomly assigned to initiate treatment with a surgical (surgery for stress incontinence) vs. a non-surgical (drug and behavioral therapy) approach. Follow-up will be a minimum of 12 Months.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The purpose of this study is to compare treatment outcomes for patients with mixed urinary incontinence (MUI) for whom therapy is initiated with surgery to those for whom therapy is initiated with non-surgical treatment. Women who are bothered by symptoms of both stress and urge incontinence will be randomly assigned to initiate treatment with a surgical (surgery for stress incontinence) vs. a non-surgical (drug and behavioral therapy) approach. Follow-up will be a minimum of 12 Months.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

27

Fase

  • Fase 4

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, 35294
        • University of Alabama
    • California
      • San Diego, California, Forenede Stater, 92103
        • University of California
    • Illinois
      • Maywood, Illinois, Forenede Stater, 60153
        • Loyola University Medical Center
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • University of Maryland
    • Michigan
      • Dearborn, Michigan, Forenede Stater, 48123
        • Oakwood Hospital/Cancer Center
      • Royal Oak, Michigan, Forenede Stater, 48073
        • Beaumont Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • University of Pittsburgh
    • Texas
      • Dallas, Texas, Forenede Stater, 75390
        • University of Texas Southwestern
      • San Antonio, Texas, Forenede Stater, 78229-3900
        • University of Texas Health Sciences Center
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84132
        • University of Utah

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

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  1. Female
  2. Mixed UI as evidenced by stress and urge symptoms reported on MESA (either percent of urge-type symptoms ≥ the percent of stress-type symptoms or urge symptom score ≥7 if stress predominant) followed by report of "moderately" or "greatly"/"quite a bit" bothered to questions 2 and 3 of the 6-item Urinary Distress Index (UDI-6) or questions 16 and 17 of the 20-item Pelvic Fl;oor Distress Index (PFDI-20), respectively (See Appendix C)
  3. Moderate or severe UI as evidenced by the corresponding response on the Patient Global Impression of Severity (PGI-S)
  4. Incontinence symptoms present for at least (3) months*
  5. Bladder capacity > 200cc (by any method)
  6. Urodynamic Stress Incontinence
  7. Eligible for both treatment interventions
  8. Available to start intervention within 6 weeks
  9. Negative urine dipstick (negative result = trace or less for leukocytes & nitrites)
  10. Available for 12 months of follow-up and able to complete study assessments as per clinician judgment
  11. Signed consent form

Exclusion Criteria:

  1. Age <21 years*
  2. Currently undergoing or recommended to undergo treatment of pelvic organ prolapse
  3. Other indicated/planned concomitant surgery
  4. Pregnant or has not completed child bearing*
  5. <12 months post-partum*†
  6. Active malignancy of cervix, uterus, fallopian tube(s) or ovary > Stage I, or bladder of any Stage
  7. Current catheter use
  8. Unevaluated hematuria

  9. Participation in another trial that may influence the results of this study

    • Patient can be rescreened after respective time interval has been met. †"Partum" is defined as a delivery or other termination that occurs after 20 weeks gestation.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Surgical Treatment
Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.
Procedure: Surgical
Initial surgical (stress incontinence surgery) treatment approach.
Andre navne:
  • Kirurgisk behandling
Aktiv komparator: Non Surgical Treatment

The non-surgical treatment will include two components:

  1. Pharmacological therapy with any FDA approved overactive bladder (OAB) drug in approved doses; and
  2. Behavioral therapy.
Medicin: Non-Surgical Intervention
Both oral urge incontinence medication and behavioral treatment
Andre navne:
  • Ikke-kirurgisk behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Optimal Outcome of Treatment at 6 Months
Tidsramme: 6 Months
Composite measure defined as "much better" or "very much better" on Patient Global Impression of Improvement (PGI-I) and "normal" or "mild" on Patient Global Impression of Symptoms (PGI-S). PGI-I is a single item: "Circle the one answer that best describes your urinary tract condition now, compared to how it was before your incontinence treatment" with responses ranging from 1= "Very much better" to 7= "Very much worse." The PGI-S is a single item:; "Circle the one number that best describes how your urinary tract condition is now" with responses ranging from 1 = "Normal" to 4 "Severe".
6 Months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Optimal Outcome of Treatment at 3 Months
Tidsramme: 3 months
Composite measure defined as "much better" or "very much better" om PGI-I and "normal" or "mild" on PGI-S. PGI-I is a single item: "Circle the one answer that best describes how your urinary tract condition is now, compared with how it was before your incontinence treatment" with responses ranging from 1="Very much better" to 7="Very much worse." PGI-S is a single items: "Circle the one number that best describes how your urinary tract condition is now" with responses ranging from 1="Normal" to 4="Severe."
3 months

Samarbejdspartnere og efterforskere

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

Sponsor

HealthCore-NERI

Samarbejdspartnere

University of California, San Diego
University of Maryland
University of Alabama at Birmingham
University of Pittsburgh
University of Texas
University of Utah
Loyola University
The University of Texas at San Antonio
Beaumont Hospital

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. oktober 2008

Primær færdiggørelse (Faktiske)

1. marts 2009

Studieafslutning (Faktiske)

1. marts 2009

Datoer for studieregistrering

Først indsendt

4. december 2008

Først indsendt, der opfyldte QC-kriterier

4. december 2008

Først opslået (Skøn)

5. december 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. maj 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. maj 2013

Sidst verificeret

1. maj 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MIMOSA (terminated)

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 .

Abonner