- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02645136
The Effects of Pilates in Muscle Strength of the Pelvic Floor as Treatment of Post Prostatectomy Urinary Incontinence
The Effects of Pilates Method in Muscle Strength of the Pelvic Floor as Treatment of Post Prostatectomy Urinary Incontinence: : a Randomized Control Trial
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control
Control Group
|
|
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.
|
Pilates exercises
|
Active Comparator: 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.
|
conventional pelvic floor muscle exercises combined with anal electrical stimulation Device: electrical stimulation (Dualpex 961 Uro®)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
improves muscle strength of the pelvic floor at 3 months
Time Frame: baseline and 3 months
|
Evaluation of the contraction capacity of the pelvic floor using perineometer (Myomed 932 Enraf/Nonius®)
|
baseline and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in the International Consultation of Urinary Incontinence- Short Form questionnaire at 3 months
Time Frame: baseline and 3 months
|
baseline and 3 months
|
Change in Pad test 24 hours at 3 months
Time Frame: baseline and 3 months
|
baseline and 3 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 820.529
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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