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Completed

NCT Number: NCT03058042

Outpatient and Home Pelvic Floor Training for Stress Urinary Incontinence

The objective of this study is to compare the effect of outpatient pelvic floor muscle training versus home pelvic floor muscle training in the treatment of stress urinary incontinence. The hypothesis of this study is that home pelvic floor muscle training is as effective as outpatient pelvic floor muscle training for the treatment of stress urinary incontinence.

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Key information

About this study

Success with the pelvic floor muscle training (PFMT) is hampered by non-adherence, which is related to factors such as inability to contract the pelvic floor muscles and lack of motivation. Thus under supervision by a physiotherapist (outpatient training), PFMT has the potential of improving adherence to training and has been demonstrated to be more effective when compared to unsupervised PFMT (home training). The objective of this study is to compare the effect of outpatient pelvic floor muscle training versus home pelvic floor muscle training in the treatment of stress urinary incontinence. This is a randomized controlled trial and which will be conducted at the Division of Urogynecology and Reconstructive Pelvic Surgery at the Federal University of Sao Paulo, Brazil. As a primary endpoint, the standardized volume test pad (250 mL) will be used. To assert that one of the groups (home PFMT or outpatient PFMT) is superior to the other, it will be necessary to find 38.5% more patients cured when the groups are compared. Secondary outcome measures will be used, assessment of the pelvic floor muscles function, urinary symptoms, quality of life and subjective cure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

SUI and mixed urinary incontinence with predominant symptoms of SUI with ≥ 2 g of leakage measured by pad test

Exclusion criteria

younger than 18 years old chronic degenerative diseases pelvic organ prolapse greater than stage I by POP-Q neurologic or psychiatric diseases inability to contract PFMs previously undergone pelvic floor re-education programs and/or previous pelvic floor surgeries

Treatment and study plan

Exercises of the pelvic floor muscle at home

Other

Patients will perform pelvic floor exercises at home.

Exercises of the pelvic floor muscle in the outpatient

Other

Patients will perform pelvic floor exercises in the outpatient.

Primary outcomes

  1. Change in pad test

    Time frame: Baseline, after 3 months of treatment

    To quantify the severity of SUI and as the tool to estimate objective cure rate

Secondary outcomes

  1. Change in 7-Day Voiding Diary

    Time frame: Baseline and after 3 months of treatment

    To assess the loss efforts

  2. Change in pelvic floor muscle function (Oxford Grading Scale)

    Time frame: Baseline and after 3 months of treatment

    To assess the function of the pelvic floor muscle

  3. Change in Incontinence Quality-of-Life Questionnaire (I-QoL)

    Time frame: Baseline and after 3 months of treatment

    To quantify the impact of SUI on quality of life

  4. Subjective cure of SUI ("satisfied" or "dissatisfied")

    Time frame: Baseline and after 3 months of treatment

    To evaluate the patient satisfaction with treatment

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

Outpatient Pelvic Floor Muscle Training Versus Home Pelvic Floor Muscle Training for Stress Urinary Incontinence: Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 20, 2017
Registry last updated
Feb 7, 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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