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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BF group | Experimental | 24 outpatient sessions of the PFMT (twice a week) using manometric-based BF equipment and daily home PFMT exercises. |
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| PFMT group | Active Comparator | 24 outpatient sessions (twice a week) of PFMT without BF and daily home PFMT exercises. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PFMT with biofeedback + Home PFMT | Other | 24 outpatient sessions PFMT with biofeedback (twice a week). Simultaneously, it was prescribed a home exercise daily program during three months (supervised treatment). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 7-Day Voiding Diary | To assess the loss efforts | Baseline, after 3 months of supervised treatment and at 9-month follow-up |
| Change in pelvic floor muscle function (Oxford Grading Scale) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fatima F Fitz, M.Sc | Federal University of São Paulo | Principal Investigator |
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The individual participant data (IPD) collected in this study are being analyzed by the researchers to be available.
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D009043 | Motor Activity |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
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|
| PFMT without biofeedback + Home PFMT | Other | 24 outpatient sessions PFMT without biofeedback (twice a week). Simultaneously, it was prescribed a home exercise daily program during three months (supervised treatment). |
|
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To assess the function of the pelvic floor muscle
| Baseline, after 3 months of supervised treatment and at 9-month follow-up |
| 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 |
| 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 |
| 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 |
| 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 |
| Frequency of the outpatient sessions | The frequency of the outpatient sessions was monitored | After 3 months of supervised treatment |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |