Study of the Efficacy of 4 Treatments for Fecal Incontinence in Community-dwelling Women
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Kegel exercises
Pelvic floor exercises designed in the 1950s' by Arnold Kegel.
|
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.
|
|
Eksperimentell: biofeedback
Biofeeback therapy to improve neuromuscular coordination and strengthen sphincter contractility.
|
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.
|
|
Eksperimentell: electrostimulation
Administration of electric current with a specific device (stimulator) and through a vaginal prove, in order to improve pelvic floor contractility.
|
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.
|
|
Eksperimentell: transcutaneous neuromodulation
Stimulation of tibial nerve with a specific electric current through a stimulator and surface electrodes
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IF02-11/2012
Plan for individuelle deltakerdata (IPD)
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