Clinical trial NCT03220672: Effectiveness of Assessment and Educational Intervention on Motor Control of the Pelvic Floor Muscle in Women
Official title: Effectiveness of a Tailored Assessment and Educational Intervention on Motor Control of the Pelvic Floor Muscle in Menopausal and Peri-menopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Perimenopausal Disorder
Keywords: Pelvic floor muscles
pelvic floor muscle training
motor control
Educational intervention
menopause
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Motor Control of Pelvic Floor Muscle by single questionnare
timeFrame: inmediate effect post education
Secondary outcomes:
measure: Anthropometric
timeFrame: baseline, inmediate effect post education and 2,4 and 12 weeks. Long time effect 6 months
measure: Interview about urinary incontinence
timeFrame: baseline, inmediate effect post education and 2,4 and 12 weeks. Long time effect 6 months
measure: The International Consultation on Incontinence Questionnaire (ICIQ-UI SHORT FORM)
timeFrame: baseline, inmediate effect post education and 2,4 and 12 weeks. Long time effect 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.