The Efficacy of Pilates in the Recovery of Post-prostatectomy Urinary Incontinence

Not Applicable

Completed

• Conditions: Prostate Cancer; Urinary Incontinence
• Interventions: Other: PILATES; Other: PFMT and AES

• Registration Number: NCT02086266
• Lead Sponsor: Universidade Estadual de Londrina

Brief Summary

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 the recovery of urinary continence (UI) after radical prostatectomy.

There are no studies that evaluate Pilates mat exercises for incontinence in men although it can be assured that this method has the pelvic floor contractions as a principle for practice. If this new therapeutic approach proves to be as effective as described treatment in improving urinary complaints, it will be an option for patients who prefer a non-invasive treatment.

Detailed Description

This randomized clinical trial includes 69 individuals with urinary incontinence one month after radical prostatectomy. One physiotherapist, with experience in urogynecology, was responsible for all the assessments. Urinary frequency, nocturia, 24-hour pad test, number of pads used per day, and the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) were the variables evaluated.

The subjects were allocated in one of two treatment groups (G1: Pilates; G2: anal electrical stimulation combined with pelvic floor muscle training). Volunteers participated of 10 sessions of the corresponding treatment and were reassessed objectively by the number of pads used per day, and subjectively with the score of quality of life.

Study Timeline

• Study Start: 2012-03
• Status Verified: 2014-03
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Study First Submitted: 2014-03-09
• Study First Submitted QC: 2014-03-11
• Last Update Submitted: 2014-03-11
• Study First Posted: 2014-03-13
• Last Update Posted: 2014-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PILATES	PILATES	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.
PFMT and AES	PFMT and AES	For also 10 weeks, the participants went trough anal electrical stimulation associated with Pelvic Floor Muscle Training, supervised by a specialized physiotherapist. All subjects received orientation to perform the same pelvic floor exercises at home.

Primary Outcome Measures

Name	Time	Method
Change in the number of pads used per day at 3 months	3 months

Secondary Outcome Measures

Name	Time	Method
Change in the 24 hours Pad Test at 3 months	3 months
Change in the episodes of nocturia at 3 months	3 months
Change in the International Consultation of Urinary Incontinence- Short Form at 3 months	3 months