Outpatient Biofeedback in Addition to Home Pelvic Floor Muscle Exercises

Urinary Incontinence, Stress Clinical Trial

Official title:

Outpatient Biofeedback in Addition to Home Pelvic Floor Muscle Training for Stress Urinary Incontinence: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02851719
• Other study ID #: 02
• Status: Completed
• Phase: N/A
• First received: July 28, 2016
• Last updated: August 1, 2016
• Start date: March 2011
• Est. completion date: September 2014

Study information

• Verified date: August 2016
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

To test whether biofeedback (BF) added to pelvic floor muscle training (PFMT) promotes additional benefits over PFMT alone in the stress urinary incontinence (SUI) treatment.

Description:

Introduction: The aim of this study was to test the hypothesis that outpatient BF added to home PFMT results in increased frequency of home exercises sets per month performed by the patients and objective cure rate after 3 months of supervised training. Secondarily, to investigate other subjective and objective clinical parameters in the groups that received or not BF together with PFMT after 3 months of supervised training, and in a longer term of 9-month follow-up.

Method: 72 incontinent women were randomized to the: BF Group (outpatient BF + home PFMT) or PFMT Group (outpatient PFMT + home PFMT).

Assessments: baseline after 3 months of supervised treatment and at 9-month follow-up (after 6 additional months of home PFMT without supervision).

Primary outcomes: adherence - monthly exercises sets performed (exercise diary) and objective cure of SUI (pad test) after 3 months.

Secondary outcomes: urinary symptoms, muscle function, quality of life, adhesion and subject cure at the two time-points.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: September 2014
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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

• previously undergone pelvic floor re-education programs and/or previous pelvic floor surgeries

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Other:
• PFMT with biofeedback + Home PFMT
24 outpatient sessions PFMT with biofeedback (twice a week). Simultaneously, it was prescribed a home exercise daily program during three months (supervised treatment).
• PFMT without biofeedback + Home PFMT
24 outpatient sessions PFMT without biofeedback (twice a week). Simultaneously, it was prescribed a home exercise daily program during three months (supervised treatment).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Conselho Nacional de Desenvolvimento Científico e Tecnológico

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 supervised treatment and at 9-month follow-up	No
Secondary	Change in 7-Day Voiding Diary	To assess the loss efforts	Baseline, after 3 months of supervised treatment and at 9-month follow-up	No
Secondary	Change in pelvic floor muscle function (Oxford Grading Scale)	To assess the function of the pelvic floor muscle	Baseline, after 3 months of supervised treatment and at 9-month follow-up	No
Secondary	Change in pelvic floor muscle function (Peritron manometer)	To assess the function of the pelvic floor muscle	Baseline, after 3 months of supervised treatment and at 9-month follow-up	No
Secondary	Change in Incontinence Quality-of-Life Questionnaire (I-QoL)	To quantify the impact of SUI on quality of life	Baseline, after 3 months of supervised treatment and at 9-month follow-up	No
Secondary	Subjective cure of SUI ("satisfied" or "dissatisfied")	To evaluate the patient satisfaction with treatment	After 3 months of supervised treatment and at 9-month follow-up	No
Secondary	Frequency and adhesion to the home exercises	The weekly frequency (days/week that patients performed at least 1 set of exercises) and the number of sets per day	After 3 months of supervised treatment and at 9-month follow-up	No
Secondary	Frequency of the outpatient sessions	The frequency of the outpatient sessions was monitored	After 3 months of supervised treatment	No