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
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
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
NCT ID
NCT02086266
First Posted
March 9, 2014
Last Updated
March 11, 2014
Sponsor
Universidade Estadual de Londrina
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
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