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OpenTrials
Completed

NCT Number: NCT03514147

Pelvic Floor Muscle Training on the Quality of Life in Women With Urinary Incontinence

Aim: To assess the influence of pelvic floor muscles group training in the quality of life and functionality of these muscles in women with UI.

Study design: This is a randomized controlled trial.

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Key information

About this study

Search location: Urogynecology Ambulatory Care of Porto Alegre Clinical Hospital (HCPA)

Patients or participants: Women will be included in aged 35-70 years who have had sexual intercourse in the last 12 months and who are able to understand the instruments, besides signing an informed consent form. Women will be excluded with latex allergy, who have made pelvic radiotherapy, or be undergoing chemotherapy, puerperal a year, or who use antidepressants and / or anxiolytics.

Intervention and measures: The evaluation consists of a medical history form, which will include personal data; the assessment of the MAP function is performed by the pressure biofeedback; for assessment of quality of life will use the questionnaire ICQI-SF and sexual function the PISQ-12 before and after Pelvic Floor Muscle Training.

Expected results: To estimate effectiveness of Pelvic Floor Muscle Training in the quality of life and functionality of these muscles in women with urinary incontinence.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Female;
  • Have urinary incontinence;
  • Age between 35 and 70 years;
  • Have sexual intercourse in the last 6 months;
  • Participants should understand the instruments used in the research;
  • Accept to participate in the study and sign the Term of Free and Informed Consent.

Exclusion criteria

  • Latex allergy;
  • Have performed or are undergoing pelvic radiotherapy;
  • Be performing chemotherapy treatment;
  • Women who delivered during the last 12 months;
  • Have participated in individual or group MAP training in the last 6 months;
  • Have contraction of the pelvic floor muscles grade zero (0).

Treatment and study plan

Experimental

Other
  • Profile of participants: an anamnesis file was used to collect personal data;
  • To evaluate the quality of life: To evaluate the quality of life, using International Consultation on Incontinence Questionnaire (ICIQ-Short form) in women with urinary incontinence in baseline and after 12 weeks of intervention;
  • To evaluate the pelvic floor muscle functionality: To evaluate the pelvic floor muscle functionality, using PERFECT Scale and Pressure Biofeedback in baseline and after 12 weeks of intervention;

Other names: Pelvic Floor Muscle Training in group

Control

Other
  • Profile of participants: an anamnesis file was used to collect personal data;
  • To evaluate the quality of life: To evaluate the quality of life, using International Consultation on Incontinence Questionnaire (ICIQ-Short form) in women with urinary incontinence in baseline and after 12 weeks of intervention;
  • To evaluate the pelvic floor muscle functionality: To evaluate the pelvic floor muscle functionality, using PERFECT Scale and Pressure Biofeedback in baseline and after 12 weeks of intervention;

Other names: Pelvic Floor at Home

Primary outcomes

  1. Quality of life in women with urinary incontinence

    Time frame: 12 weeks

    International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) - scored between 0 and 21.

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

The Effect of Pelvic Floor Muscle Training on the Quality of Life and Functionality in Women With Urinary Incontinence: a Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 2, 2018
Registry last updated
May 2, 2018

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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