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Effectiveness of Assessment and Educational Intervention on Motor Control of the Pelvic Floor Muscle in Women (MENO_edu)

17. juli 2017 oppdatert av: Dr. Antonio I Cuesta-Vargas, University of Malaga

Effectiveness of a Tailored Assessment and Educational Intervention on Motor Control of the Pelvic Floor Muscle in Menopausal and Peri-menopausal Women

The goal of the present study is to evaluate the short and long term effectiveness of a tailored assessment and educational intervention on motor control of the pelvic floor muscle in menopausal and non-menopausal women.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Menopausal transition has been related to stress urinary incontinence. The transition from the reproductive to the non-reproductive period is induced by a decrease in sex hormone production in the ovaries. Climacteric-stage oestrogen deficiency produces genital and urinary tract atrophy, which may be related to symptoms such as urinary frequency, urinary urgency, nocturia incontinence, and recurrent urinary tract infection. Urinary incontinence seems to appear due to a combination of factors such as pelvic floor weakness and tearing, denervation and fascial tears as well as both loss of motor units and altered activation patterns. However, physiotherapy can treat weakness and altered motor control in order to compensate for other factors. In fact, physiotherapy is considered the treatment of first choice.

Besides evidence defending physiotherapy as first line conservative therapy in incontinence due to influence of strength and motor control in this pathology and its prevalence in perimenopause women, little is known about its effects in this population. Hence, the aim of this study is to evaluate the short and long term effectiveness of a tailored assessment and educational intervention on motor control of the pelvic floor muscle in menopausal and peri-menopausal women.

Studietype

Intervensjonell

Registrering (Faktiske)

120

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • All participants in this study will sign an informed consent form prior their inclusion, and that whose participation will be voluntary

Exclusion Criteria:

  • Participants will be excluded if they have any cognitive disability, physical disability or psychiatric limitations that could limit the participation on the study test

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Expertimental
The sample will receive a tailored assessment and educational intervention on Motor Control of the Pelvic Floor Muscle
Atferdsmessig: Tailored assessment and educational
Intervention will consist of 45 minutes of anatomy education, pelvic floor assessment and neuromuscular re-education. Women will be given an explanation of how the pelvis is composed, including the viscera and pelvic floor function and anatomy, through a simple explanatory sheet. They will be also informed of the causes of pelvic floor deterioration as well as its consequences.. Neuromuscular re-education will continued by teaching them how to perform slow contractions, fast contractions and lifting contraction. They will be also shown vaginal cones and advised on possible treatment methods if they were needed. After that, women will be given a tip sheet to improve pelvic floor function. Those recommendations will included: Tips to take into account during habits like urination, doing sport, gymnastics or any efforts, pelvic floor muscles exercises and how to use vaginal cones adequately.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Motor Control of Pelvic Floor Muscle by single questionnare
Tidsramme: inmediate effect post education

Women will report an outcome regarding tightening capacity after intervention. It consisted of a one item questionnaire about pelvic floor contraction capacity. It is chosen by the expert panel developed by researcher from this project. The item is a question regarding tightening capacity and it had a polychotomous answer:

"How is the tightening capacity of your pelvic floor muscles?

a) very high, b) high, c) good, d) optimal, e) bad, f) low, g) very low"
inmediate effect post education

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Anthropometric
Tidsramme: baseline, inmediate effect post education and 2,4 and 12 weeks. Long time effect 6 months
Age, height and weight, and their Body Mass Index (BMI) was calculated.
baseline, inmediate effect post education and 2,4 and 12 weeks. Long time effect 6 months
Interview about urinary incontinence
Tidsramme: baseline, inmediate effect post education and 2,4 and 12 weeks. Long time effect 6 months
Women will also underwent an interview about urinary incontinence with a physiotherapist from the Consulting Unit of Physiotherapy of the Pelvic Floor. The questionnaire consisted of 38 items regarding delivery conditions, faecal and urinary incontinence as well as medical conditions and lifestyle. This interview includes information from descriptive outcomes reported by the clinician, so pelvic floor muscles will be evaluated by both manual muscle testing and a perineometer. Hence, this interview has both qualitative and quantitative reponses.
baseline, inmediate effect post education and 2,4 and 12 weeks. Long time effect 6 months
The International Consultation on Incontinence Questionnaire (ICIQ-UI SHORT FORM)
Tidsramme: baseline, inmediate effect post education and 2,4 and 12 weeks. Long time effect 6 months
The ICIQ is a simple and short questionnaire to assess the symptoms and impact of UI across the population. It consists of 3 items which indicate frequency, quantity and impact, and 8 questions more related to the symptoms indicative of the type of UI, but not being contemplated when obtaining a global index. The ICIQ-UI short form has a good reliability with a Cronbach's alpha of 0.95. It was validated in Spanish by Espuña et al, with a Cronbach's alpha of 0.89
baseline, inmediate effect post education and 2,4 and 12 weeks. Long time effect 6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Malaga

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2017

Primær fullføring (Faktiske)

1. juni 2017

Studiet fullført (Faktiske)

1. juli 2017

Datoer for studieregistrering

Først innsendt

4. juli 2017

Først innsendt som oppfylte QC-kriteriene

17. juli 2017

Først lagt ut (Faktiske)

18. juli 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. juli 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. juli 2017

Sist bekreftet

1. juni 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • Meno_Edu_2017

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Nei

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