Urinary Incontinence, Stress
Conditions
Keywords
Urinary Incontinence, Stress, Pelvic Floor, Exercise, Patient Compliance
Brief 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.
Detailed 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.
Interventions
OTHERPFMT 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).
OTHERPFMT 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).
Sponsors
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pad test | Baseline, after 3 months of supervised treatment and at 9-month follow-up | To quantify the severity of SUI and as the tool to estimate objective cure rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pelvic floor muscle function (Oxford Grading Scale) | Baseline, after 3 months of supervised treatment and at 9-month follow-up | To assess the function of the pelvic floor muscle |
| Change in pelvic floor muscle function (Peritron manometer) | Baseline, after 3 months of supervised treatment and at 9-month follow-up | To assess the function of the pelvic floor muscle |
| Change in Incontinence Quality-of-Life Questionnaire (I-QoL) | Baseline, after 3 months of supervised treatment and at 9-month follow-up | To quantify the impact of SUI on quality of life |
| Change in 7-Day Voiding Diary | Baseline, after 3 months of supervised treatment and at 9-month follow-up | To assess the loss efforts |
| Frequency and adhesion to the home exercises | After 3 months of supervised treatment and at 9-month follow-up | The weekly frequency (days/week that patients performed at least 1 set of exercises) and the number of sets per day |
| Frequency of the outpatient sessions | After 3 months of supervised treatment | The frequency of the outpatient sessions was monitored |
| Subjective cure of SUI (satisfied or dissatisfied) | After 3 months of supervised treatment and at 9-month follow-up | To evaluate the patient satisfaction with treatment |
Outcome results
None listed