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

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ClinicalTrials.gov Identifier: NCT03514147
Recruitment Status : Completed
First Posted : May 2, 2018
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Urinary Incontinence Quality of Life Other: Experimental Other: Control Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Pelvic Floor Muscle Training on the Quality of Life and Functionality in Women With Urinary Incontinence: a Randomized Controlled Trial
Actual Study Start Date : October 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental
Pelvic Floor Muscle Training in group. Exercise Protocol: The exercise group was supervised and met for 1 hour, one time per week, for 12 weeks. Participants were instructed to perform their respective daily exercises.
Other: Experimental
  1. Profile of participants: an anamnesis file was used to collect personal data;
  2. 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;
  3. 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 Name: Pelvic Floor Muscle Training in group

Active Comparator: Control
Pelvic Floor Muscle Training in home Exercise Protocol:The same exercise were performed at home for 12 weeks, without supervision. Participants were instructed to perform their respective daily exercises.
Other: Control
  1. Profile of participants: an anamnesis file was used to collect personal data;
  2. 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;
  3. 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 Name: Pelvic Floor at Home




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514147


Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: José Geraldo Lopes Ramos Hospital de Clínicas de Porto Alegre

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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03514147     History of Changes
Other Study ID Numbers: 15-0271
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Hospital de Clinicas de Porto Alegre:
Women
Pelvic Floor Muscles
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders