search
Back to results

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

Primary Purpose

Prostate Cancer, Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PILATES
PFMT and AES
Sponsored by
Universidade Estadual de Londrina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostatectomy, Urinary Continence, Physical Therapy Modalities, Pelvic Floor, Randomized Trial.

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    PILATES

    PFMT and AES

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    March 9, 2014
    Last Updated
    March 11, 2014
    Sponsor
    Universidade Estadual de Londrina
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02086266
    Brief Title
    The Efficacy of Pilates in the Recovery of Post-prostatectomy Urinary Incontinence
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2012 (undefined)
    Primary Completion Date
    March 2014 (Actual)
    Study Completion Date
    March 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Estadual de Londrina

    4. Oversight

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer, Urinary Incontinence
    Keywords
    Prostatectomy, Urinary Continence, Physical Therapy Modalities, Pelvic Floor, Randomized Trial.

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    54 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PILATES
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    PFMT and AES
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    PILATES
    Intervention Type
    Other
    Intervention Name(s)
    PFMT and AES
    Primary Outcome Measure Information:
    Title
    Change in the number of pads used per day at 3 months
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Change in the 24 hours Pad Test at 3 months
    Time Frame
    3 months
    Title
    Change in the International Consultation of Urinary Incontinence- Short Form at 3 months
    Time Frame
    3 months
    Title
    Change in the episodes of nocturia at 3 months
    Time Frame
    3 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs