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Self-Care to Prevent Birth-Related Urinary Incontinence in Diverse Women

14 januari 2015 bijgewerkt door: Carolyn Sampselle, University of Michigan

PERL 4: Promoting Effective Recovery From Labor

The primary goal of this project is to determine the efficacy of an antenatal Bladder Health class to prevent UI in a diverse sample of African American, Caucasian, and Hispanic childbearing women. The determination of efficacy will be made at 12-months post index birth, a time point that is a traditional benchmark of recovery from childbirth, using UI incidence/severity as the primary outcome.

Studie Overzicht

Gedetailleerde beschrijving

This study is significant because UI prevalence is 34% overall among US women, nearly half of whom consider their incontinence to be moderately to extremely bothersome. UI is 2.0 to 2.6 fold greater in women after pregnancy and childbirth as compared to their never pregnant counterparts, with the incidence increasing after each child. UI impact increases as women age extending into middle and later life. The financial cost of UI in the United States exceeds $19 billion per year . Other costs are identified in the Healthy People 2010 report 22 and include: 1) decreased activity/ fitness, which can be seriously affected because women who are concerned about accidental leakage markedly curtail physical activity and 2) increased depression, which has been linked to UI in women. Women are at least twice as likely as men to have UI; pregnancy and childbirth are major explanatory factors. In perimenopausal women, prevalence of any UI was 57% and of moderate to severe UI was 25%; after controlling for age, race/ethnicity, menopausal status and body mass index, parity persisted as a significant predictor of UI with an OR of 1.62 (CI 1.31, 2.01).

Noninvasive interventions during the period of childbearing are of particular interest for UI prevention in women. Two self-management practices recommended for the initial treatment of UI are: Pelvic floor muscle training (PFMT), defined by the International Continence Society as repetitive selective voluntary contraction and relaxation of specific pelvic floor muscles, and bladder training (BT), defined as a program of scheduled voiding with gradually progressive voiding intervals. The Knack Maneuver (a preemptive pelvic floor muscle contraction to decrease stress UI and/or suppress urge UI) has demonstrated efficacy in older women diagnosed with UI. In childbearing women, only PFMT has been tested with a rigorous RCT design. We taught PFMT, the Knack, and BT as a combined strategy to older women and found a two-fold prevention effect. The proposed project is innovative because it will be the first to our knowledge to test the preventive capacity of an intervention in childbearing women that combines PFMT, the Knack, and BT. This project is also innovative because it will be conducted with a diverse sample of primiparous/multiparous women, using a 3-year follow-up period. Because PFMT is the only self-management strategy that is currently recommended practice for maternity patients, we will use PFMT adherence in comparisons between the treatment and control conditions

Recruitment and Informed Consent:

Fliers specifying eligibility criteria and benefits of research participation will be prominently displayed in the waiting areas and in the women's bathrooms of the respective clinical sites. Potential participants will be invited to speak with a designated site-based contact re: what participation in the study would entail. This individual will answer initial questions, review written material that describes study participation, conduct verbal screening, and obtain informed consent from eligible individuals. Eligible participants will be scheduled for a clinic visit at the respective site for a clinic visit to obtain clinical verification of no objective incontinence (negative standing stress test) and evidence of ability to contract the pelvic floor correctly (digital measure). Following determination of eligibility, participants will be randomized into control (routine care) or treatment (scheduled for Bladder Health class) condition.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

432

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Michigan
      • Ann Arbor, Michigan, Verenigde Staten, 48109
        • University of Michigan Health System
      • Jackson, Michigan, Verenigde Staten, 49202
        • Jackson Center for Family Health
      • Pontiac, Michigan, Verenigde Staten, 48341
        • La Clinica de la Santa Teresa

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

Inclusion Criteria:

Women who are pregnant and expecting their first, second, or third baby are eligible if they:

  • are age eighteen years or older
  • are able to understand and read English or Spanish
  • are low risk antepartum (first, second or third pregnancy)
  • are 16-25 weeks pregnant
  • expect a vaginal birth
  • have lost no more than a few drops of urine as often as every other day
  • have no previous or current urinary incontinence treatment with medication, formal behavioral programs or surgery
  • have no history of bladder cancer, diabetes, stroke, multiple sclerosis, muscular dystrophy, cerebral palsy, Parkinson's, epilepsy, or trauma of the spinal cord
  • Do not have (or have not had within the last 3 years) *chronic urinary tract infection. *Chronic is defined as having more than 3 urinary tract infections in one year.

Exclusion Criteria:

  • If participant does not meet all of the above criterion for inclusion

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 1 Usual Care
This group will receive routine care, however, it is possible that that control condition participants will receive Pelvic Floor Muscle Training (PFMT) instruction from their health care providers. We will monitor control women's knowledge, adoption and maintaining of PFMT
This group will receive routine care, however, it is possible that that control condition participants will receive Pelvic Floor Muscle Training (PFMT) instruction from their health care providers. We will monitor control women's knowledge, adoption and maintaining of PFMT.
Experimenteel: 2 Bladder Health Class
Modeled on our intervention with older women, Bladder Health Class (BH Class) will include Pelvic floor muscle training (PFMT), defined by the International Continence Society as repetitive selective voluntary contraction and relaxation of specific pelvic floor muscles, and bladder training (BT), defined as a program of scheduled voiding with gradually progressive voiding intervals. The BT instructions will be modified for this pregnant group. We will monitor control women's knowledge, adoption and maintaining of PFMT and BT.
Modeled on our intervention with older women, Bladder Health Class (BH Class) will include Pelvic floor muscle training (PFMT), defined by the International Continence Society as repetitive selective voluntary contraction and relaxation of specific pelvic floor muscles, and bladder training (BT), defined as a program of scheduled voiding with gradually progressive voiding intervals. The BT instructions will be modified for this pregnant group. We will monitor control women's knowledge, adoption and maintaining of PFMT and BT.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
UI incidence/severity
Tijdsspanne: 12 months - 3 years post-index birth
12 months - 3 years post-index birth

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Carolyn Sampselle, PhD RNC FAAN, University of Michigan, School of Nursing, Grants and Research Office

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 oktober 2007

Primaire voltooiing (Werkelijk)

1 december 2013

Studie voltooiing (Werkelijk)

1 december 2013

Studieregistratiedata

Eerst ingediend

30 september 2008

Eerst ingediend dat voldeed aan de QC-criteria

30 september 2008

Eerst geplaatst (Schatting)

1 oktober 2008

Updates van studierecords

Laatste update geplaatst (Schatting)

15 januari 2015

Laatste update ingediend die voldeed aan QC-criteria

14 januari 2015

Laatst geverifieerd

1 januari 2015

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 2R01NR007618-06A1 (Subsidie/contract van de Amerikaanse NIH)
  • 2R01NR007618 (Subsidie/contract van de Amerikaanse NIH)
  • HUM00015712 (Andere identificatie: University of Michigan IRB)
  • NCT00763984 (Register-ID: ClinicalTrials.govID)

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