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

NCT ID: NCT02645136

Last Updated: 2016-01-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-07-31

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).

Conditions

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Prostate Cancer Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Pilates exercises

PFMT and AES

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.

Group Type ACTIVE_COMPARATOR

PFMT and AES

Intervention Type OTHER

conventional pelvic floor muscle exercises combined with anal electrical stimulation Device: electrical stimulation (Dualpex 961 Uro®)

Control

Control Group

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

Interventions

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Pilates

Pilates exercises

Intervention Type OTHER

PFMT and AES

conventional pelvic floor muscle exercises combined with anal electrical stimulation Device: electrical stimulation (Dualpex 961 Uro®)

Intervention Type OTHER

Control

Intervention Type OTHER

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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Universidade Estadual de Londrina

OTHER

Sponsor Role lead

Responsible Party

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Cíntia Spagnolo Gomes

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

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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)

Gomes CS, Pedriali FR, Urbano MR, Moreira EH, Averbeck MA, Almeida SHM. The effects of Pilates method on pelvic floor muscle strength in patients with post-prostatectomy urinary incontinence: A randomized clinical trial. Neurourol Urodyn. 2018 Jan;37(1):346-353. doi: 10.1002/nau.23300. Epub 2017 May 2.

Reference Type DERIVED
PMID: 28464434 (View on PubMed)

Other Identifiers

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820.529

Identifier Type: -

Identifier Source: org_study_id

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