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Study of the Efficacy of 4 Treatments for Fecal Incontinence in Community-dwelling Women

8. januar 2018 opdateret af: Lluís Mundet, Hospital de Mataró

Study of the Efficacy of Treatment of Fecal Incontinence in Community-dwelling Women: Assessment of Individual Efficacy on Anorectal Physiology and Cortical Plasticity, Its Impact on Clinical Severity and on Quality of Life.

This is a RCT aimed to assessing efficacy of kegel exercises,biofeedback, electrostimulation and transcutaneous neuromodulation on women with fecal incontinence, measuring its impact on anorectal physiology, cortical plasticity, clmical severity and the quality of life.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Fecal incontinence is a prevalent condition with a major impact on quality of life. Currently four treatments are being used in clinical practice: Kegel exercises (K), biofeedback (BF), electrostimulation (ES) and transcutaneous neuromodulation (NM). Results in the literature are discordant and lack methodological rigour making scientific evidence weak.

The aim of this study is to assess the efficacy of these four treatments on community-dwelling women and their impact on anorectal physiology, on clinical severity and on QoL.

This is a randomized control trial. Patient physiology was studied with anorectal manometry and endoanal ultrasonography; clinical severity was assessed with Cleveland and St. Mark's scales, and QoL with the Faecal Incontinence Quality of Life (FIQL) and the EuroQol's EQ5D questionnaires. Urinary incontinence (UI) was also evaluated by means of International Consultation on Incontinence (ICIQ) score. Patients were randomized and assigned to K (control), BF+K, ES+K or NM+K, given active treatment for a 3-month period, and then evaluated again with identical tests and parameters to identify changes.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

150

Fase

  • Ikke anvendelig

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Age higher than 18
  • To be woman
  • Have had incontinence episiodes at least from 6 month since the beginning of the study
  • Have had incontinence episodes during the last month prior the beginning of the study
  • The patient is able to understand the nature and impliations of the study and, therefore, to decide her participation.

Exclusion Criteria:

  • Not meeting inclusion criteria
  • Have very mild condition (Wexner <4)
  • To be unable to perform / understand the treatments properly
  • Being pregnant
  • To have used treatmets for fecal incontinence within the last six months prior to the start of the study
  • If, at reserarcher's criteria, the patient has not the proper conditions to perform and finish the treatments.

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: Kegel exercises
Pelvic floor exercises designed in the 1950s' by Arnold Kegel.
Enhed: Pelvic floor rehabilitation
The aim is to compare how each treatment improves symptoms and quality of life and which physiologic mechanisms affects. The basal treatment which other therapies are compared to is Kegel.
Eksperimentel: biofeedback
Biofeeback therapy to improve neuromuscular coordination and strengthen sphincter contractility.
Enhed: Pelvic floor rehabilitation
The aim is to compare how each treatment improves symptoms and quality of life and which physiologic mechanisms affects. The basal treatment which other therapies are compared to is Kegel.
Eksperimentel: electrostimulation
Administration of electric current with a specific device (stimulator) and through a vaginal prove, in order to improve pelvic floor contractility.
Enhed: Pelvic floor rehabilitation
The aim is to compare how each treatment improves symptoms and quality of life and which physiologic mechanisms affects. The basal treatment which other therapies are compared to is Kegel.
Eksperimentel: transcutaneous neuromodulation
Stimulation of tibial nerve with a specific electric current through a stimulator and surface electrodes
Enhed: Pelvic floor rehabilitation
The aim is to compare how each treatment improves symptoms and quality of life and which physiologic mechanisms affects. The basal treatment which other therapies are compared to is Kegel.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
clinical severity
Tidsramme: Changes of severity after 3 month-treatment
severity of the symptoms measured with Cleveland score
Changes of severity after 3 month-treatment
maximum anal resting pressure
Tidsramme: Changes maximum anal resting pressure after 3 month-treatment
pressure of the anal canal measured with mmHg
Changes maximum anal resting pressure after 3 month-treatment
maximum squeeze pressure
Tidsramme: Changes maximum squeeze pressure after 3 month-treatment
pressure on the anal canal when squeezing measured with mmHg
Changes maximum squeeze pressure after 3 month-treatment
rectal sensitivity
Tidsramme: changes in rectal balloon filling after 3 month-treatment
patient's rectal perception, measured with cm3 of distention of a rectal balloon
changes in rectal balloon filling after 3 month-treatment

Samarbejdspartnere og efterforskere

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

Sponsor

Hospital de Mataró

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 (Faktiske)

1. februar 2013

Primær færdiggørelse (Faktiske)

1. december 2016

Studieafslutning (Faktiske)

1. marts 2017

Datoer for studieregistrering

Først indsendt

29. november 2017

Først indsendt, der opfyldte QC-kriterier

8. januar 2018

Først opslået (Faktiske)

9. januar 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. januar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. januar 2018

Sidst verificeret

1. januar 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IF02-11/2012

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Pelvic floor rehabilitation

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Placeringer

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