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

NCT ID: NCT02086266

Last Updated: 2014-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-03-31

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.

Conditions

Prostate Cancer; Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PILATES

Intervention Type: OTHER

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.

Group Type: ACTIVE_COMPARATOR

PFMT and AES

Intervention Type: OTHER

Interventions

PILATES

Intervention Type: OTHER

PFMT and AES

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Universidade Estadual de Londrina

OTHER

Sponsor Role: lead

Responsible Party

Fabiana Rotondo Pedriali

Physioterapist student of a masters degree program at the Center of Health Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Johnson EE, Mamoulakis C, Stoniute A, Omar MI, Sinha S. Conservative interventions for managing urinary incontinence after prostate surgery. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD014799. doi: 10.1002/14651858.CD014799.pub2.

Reference Type: DERIVED

PMID: 37070660 (View on PubMed)

Other Identifiers

PILUI1

Identifier Type: -

Identifier Source: org_study_id