The Effects of Pilates in Muscle Strength of the Pelvic Floor as Treatment of Post Prostatectomy Urinary Incontinence

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy between a Pilates exercise program and a Pelvic Floor Muscle Training (PFMT) protocol combined with anal electrical stimulation (AES) in muscular pressure strength of the pelvic floor as conservative treatment of urinary incontinence after prostatectomy.

Detailed Description
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This randomized clinical trial includes 115 individuals with urinary incontinence one month after radical prostatectomy. One physiotherapist, with experience in urogynecology, was responsible for all the assessments. muscular pressure strength of the pelvic floor, 24-hour pad test and the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) were the variables evaluated. The subjects were allocated in one of three treatment groups (G1: Pilates; G2: anal electrical stimulation combined with pelvic floor muscle training and G3: Control Group).

Official Title
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The Effects of Pilates Method in Muscle Strength of the Pelvic Floor as Treatment of Post Prostatectomy Urinary Incontinence: : a Randomized Control Trial

Conditions
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Prostate Cancer, Urinary Incontinence

Intervention / Treatment
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* Other: Pilates
* Other: PFMT and AES
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteers between 50 and 75 years old; Submitted to radical prostatectomy; With complaints of urinary incontinence; That completed one month of surgery; Exclusion Criteria: History of incontinence; Transurethral resection of the prostate; Diagnosis of neurological or cognitive impairment; Subjects who were unable to attend treatment sessions, due to distance or physical limitations.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PILATES<br>Weekly Pilates sessions, guided by a specialized physiotherapist. The duration of the treatment was 10 weeks, and each session lasted 45 to 50 minutes. All subjects received instruction to perform specific daily home exercises. | Other: Pilates<br>* Pilates exercises<br>|
| Active Comparator: PFMT and AES<br>For also 10 weeks, the participants went trough anal electrical stimulation (AES) associated with Pelvic Floor Muscle Training (PFMT), supervised by a specialized physiotherapist. All subjects received orientation to perform the same pelvic floor exercises at home. | Other: PFMT and AES<br>* conventional pelvic floor muscle exercises combined with anal electrical stimulation Device: electrical stimulation (Dualpex 961 Uro®)<br>|
| Placebo Comparator: Control<br>Control Group | Other: Control<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improves muscle strength of the pelvic floor at 3 months | Evaluation of the contraction capacity of the pelvic floor using perineometer (Myomed 932 Enraf/Nonius®) | baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the International Consultation of Urinary Incontinence- Short Form questionnaire at 3 months |  | baseline and 3 months | 
| Change in Pad test 24 hours at 3 months |  | baseline and 3 months |