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

14 gennaio 2015 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

432

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
UI incidence/severity
Lasso di tempo: 12 months - 3 years post-index birth
12 months - 3 years post-index birth

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2007

Completamento primario (Effettivo)

1 dicembre 2013

Completamento dello studio (Effettivo)

1 dicembre 2013

Date di iscrizione allo studio

Primo inviato

30 settembre 2008

Primo inviato che soddisfa i criteri di controllo qualità

30 settembre 2008

Primo Inserito (Stima)

1 ottobre 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

15 gennaio 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 gennaio 2015

Ultimo verificato

1 gennaio 2015

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 2R01NR007618-06A1 (Sovvenzione/contratto NIH degli Stati Uniti)
  • 2R01NR007618 (Sovvenzione/contratto NIH degli Stati Uniti)
  • HUM00015712 (Altro identificatore: University of Michigan IRB)
  • NCT00763984 (Identificatore di registro: ClinicalTrials.govID)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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