search
Back to results

The Effects of Pilates in Muscle Strength of the Pelvic Floor as Treatment 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
Control
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

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 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    PILATES

    PFMT and AES

    Control

    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 (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.

    Control Group

    Outcomes

    Primary Outcome Measures

    improves muscle strength of the pelvic floor at 3 months
    Evaluation of the contraction capacity of the pelvic floor using perineometer (Myomed 932 Enraf/Nonius®)

    Secondary Outcome Measures

    Change in the International Consultation of Urinary Incontinence- Short Form questionnaire at 3 months
    Change in Pad test 24 hours at 3 months

    Full Information

    First Posted
    December 27, 2015
    Last Updated
    December 30, 2015
    Sponsor
    Universidade Estadual de Londrina
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02645136
    Brief Title
    The Effects of Pilates in Muscle Strength of the Pelvic Floor as Treatment of Post Prostatectomy Urinary Incontinence
    Official Title
    The Effects of Pilates Method in Muscle Strength of the Pelvic Floor as Treatment of Post Prostatectomy Urinary Incontinence: : a Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    April 2015 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    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 muscular pressure strength of the pelvic floor as conservative treatment of urinary incontinence after prostatectomy.
    Detailed Description
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer, Urinary Incontinence

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    115 (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 (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.
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    Control Group
    Intervention Type
    Other
    Intervention Name(s)
    Pilates
    Intervention Description
    Pilates exercises
    Intervention Type
    Other
    Intervention Name(s)
    PFMT and AES
    Intervention Description
    conventional pelvic floor muscle exercises combined with anal electrical stimulation Device: electrical stimulation (Dualpex 961 Uro®)
    Intervention Type
    Other
    Intervention Name(s)
    Control
    Primary Outcome Measure Information:
    Title
    improves muscle strength of the pelvic floor at 3 months
    Description
    Evaluation of the contraction capacity of the pelvic floor using perineometer (Myomed 932 Enraf/Nonius®)
    Time Frame
    baseline and 3 months
    Secondary Outcome Measure Information:
    Title
    Change in the International Consultation of Urinary Incontinence- Short Form questionnaire at 3 months
    Time Frame
    baseline and 3 months
    Title
    Change in Pad test 24 hours at 3 months
    Time Frame
    baseline and 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

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    28464434
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs