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NCT Number: NCT03220672

Effectiveness of Assessment and Educational Intervention on Motor Control of the Pelvic Floor Muscle in 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.

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Key information

Conditions

Menopause Perimenopausal Disorder

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tailored assessment and educational

Behavioral

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.

Primary outcomes

  1. Motor Control of Pelvic Floor Muscle by single questionnare

    Time frame: 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"

Secondary outcomes

  1. Anthropometric

    Time frame: 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.

  2. Interview about urinary incontinence

    Time frame: 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.

  3. The International Consultation on Incontinence Questionnaire (ICIQ-UI SHORT FORM)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Malaga

Other

Registry information

Official study title

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

Acronym: MENO_edu

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 18, 2017
Registry last updated
Jul 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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