Effectiveness of Assessment and Educational Intervention on Motor Control of the Pelvic Floor Muscle in Women (MENO_edu)
Effectiveness of a Tailored Assessment and Educational Intervention on Motor Control of the Pelvic Floor Muscle in Menopausal and Peri-menopausal Women
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Expertimental
The sample will receive a tailored assessment and educational intervention on Motor Control of the Pelvic Floor Muscle
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- Chevalier F, Fernandez-Lao C, Cuesta-Vargas AI. Normal reference values of strength in pelvic floor muscle of women: a descriptive and inferential study. BMC Womens Health. 2014 Nov 25;14:143. doi: 10.1186/s12905-014-0143-4.
- Espuna Pons M, Rebollo Alvarez P, Puig Clota M. [Validation of the Spanish version of the International Consultation on Incontinence Questionnaire-Short Form. A questionnaire for assessing the urinary incontinence]. Med Clin (Barc). 2004 Mar 6;122(8):288-92. doi: 10.1016/s0025-7753(04)74212-8. Spanish.
- Bo K. Pelvic floor muscle training is effective in treatment of female stress urinary incontinence, but how does it work? Int Urogynecol J Pelvic Floor Dysfunct. 2004 Mar-Apr;15(2):76-84. doi: 10.1007/s00192-004-1125-0. Epub 2004 Jan 24.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- Meno_Edu_2017
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Tailored assessment and educational
-
Dana-Farber Cancer InstituteAfsluttetKræft | Kemoterapi-induceret perifer neuropatiForenede Stater
-
Medipol UniversityAfsluttetCAD test; børns vision; Farvevurdering; Farvesyn; KalkunKalkun
-
VA Office of Research and DevelopmentAfsluttetSlag | BalanceunderskudForenede Stater
-
Indiana UniversityIndiana University HealthAfsluttetMetastatisk kræft | Avanceret kræftForenede Stater
-
Francisco Gonzalez-Lima, PhDRekruttering
-
Indiana UniversityIndiana University Health; Regenstrief Institute, Inc.AfsluttetDepression | PTSD | Angst | Meddelelse | TilfredshedForenede Stater
-
Medical University of South CarolinaNational Institute for Biomedical Imaging and Bioengineering (NIBIB)AfsluttetTræthed | SarcoidoseForenede Stater
-
University of North Carolina, Chapel HillViiV HealthcareAfsluttet
-
Jessa HospitalAfsluttetAr | Minimalt invasiv hjertekirurgiBelgien
-
University of ArkansasAfsluttetMentalt helbredForenede Stater