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

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03514147
• Other study ID #: 15-0271
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: July 2017

Study information

• Verified date: April 2018
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Enuresis
• Quality of Life
• Urinary Incontinence

Intervention

Other:
• Experimental
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;
• Control
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;

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life in women with urinary incontinence	International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) - scored between 0 and 21.	12 weeks