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

NCT03220672 | Completed DMC

• 1 other identifier: Meno_Edu_2017
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Menopause; Perimenopausal Disorder

Keywords

Pelvic floor muscles; pelvic floor muscle training; motor control; Educational intervention; menopause

Outcome Measures

Primary Outcomes (1)

• Motor Control of Pelvic Floor Muscle by single questionnare

  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

Secondary Outcomes (3)

• Anthropometric

  baseline, inmediate effect post education and 2,4 and 12 weeks. Long time effect 6 months

• Interview about urinary incontinence

  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)

  baseline, inmediate effect post education and 2,4 and 12 weeks. Long time effect 6 months

Study Arms (1)

Expertimental

EXPERIMENTAL

The sample will receive a tailored assessment and educational intervention on Motor Control of the Pelvic Floor Muscle

Behavioral: Tailored assessment and educational

Interventions

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.

Expertimental

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Due to the aim of the study, the gender of the sample will be female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• University of Malaga: lead

Related Publications (3)

• 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.

  PMID: 25420756 BACKGROUND

• 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.

  PMID: 15030739 BACKGROUND

• 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.

  PMID: 15014933 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Researcher of CTS631 University of Malaga

Study Record Dates

• First Submitted: July 4, 2017
• First Posted: July 18, 2017
• Study Start: January 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 18, 2017

Record last verified: 2017-06