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

Sponsor

Universidade Estadual de Londrina (Other)

Overall Status

Completed

CT.gov ID

NCT02086266

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Urinary Incontinence	Other: PILATES Other: PFMT and AES	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Efficacy of Pilates Compared to Pelvic Floor Muscle Training Associated With Electrical Stimulation in the Recovery of Post-prostatectomy Urinary Incontinence: a Randomized Clinical Trial.

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: PILATES
Active Comparator: 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.	Other: PFMT and AES

Arm

Intervention/Treatment

Experimental: 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.

Other: PILATES

Active Comparator: 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.

Other: PFMT and AES

Outcome Measures

Primary Outcome Measures

Change in the number of pads used per day at 3 months [3 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Universidade Estadual de Londrina

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fabiana Rotondo Pedriali, Physioterapist student of a masters degree program at the Center of Health Science, Universidade Estadual de Londrina

ClinicalTrials.gov Identifier:

NCT02086266

Other Study ID Numbers:

PILUI1

First Posted:

Mar 13, 2014

Last Update Posted:

Mar 13, 2014

Last Verified:

Mar 1, 2014

Keywords provided by Fabiana Rotondo Pedriali, Physioterapist student of a masters degree program at the Center of Health Science, Universidade Estadual de Londrina

Prostatectomy

Urinary Continence

Physical Therapy Modalities

Pelvic Floor

Randomized Trial.

Additional relevant MeSH terms:

Urinary Incontinence

Enuresis

Study Results

No Results Posted as of Mar 13, 2014