Outpatient and Home Pelvic Floor Training for Stress Urinary Incontinence

Urinary Incontinence, Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03058042
• Other study ID #: 001
• Status: Completed
• Phase: N/A
• First received: February 15, 2017
• Last updated: February 6, 2018
• Start date: July 1, 2017
• Est. completion date: December 30, 2017

Study information

• Verified date: February 2018
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 30, 2017
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Other:
• Exercises of the pelvic floor muscle at home
Patients will perform pelvic floor exercises at home.
• Exercises of the pelvic floor muscle in the outpatient
Patients will perform pelvic floor exercises in the outpatient.

Locations

Country	Name	City	State
Brazil	Fátima Faní Fitz	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pad test	To quantify the severity of SUI and as the tool to estimate objective cure rate	Baseline, after 3 months of treatment
Secondary	Change in 7-Day Voiding Diary	To assess the loss efforts	Baseline and after 3 months of treatment
Secondary	Change in pelvic floor muscle function (Oxford Grading Scale)	To assess the function of the pelvic floor muscle	Baseline and after 3 months of treatment
Secondary	Change in Incontinence Quality-of-Life Questionnaire (I-QoL)	To quantify the impact of SUI on quality of life	Baseline and after 3 months of treatment
Secondary	Subjective cure of SUI ("satisfied" or "dissatisfied")	To evaluate the patient satisfaction with treatment	Baseline and after 3 months of treatment