Effectiveness of Physiotherapy to Treat the Urinary Incontinence and Erectile Dysfunction Post Retropubic Prostatectomy
Primary Purpose
Urinary Incontinence, Erectile Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
group of pelvic floor exercises
anal electrostimulation group
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring urinary incontinence, erectile dysfunction, Retropubic Prostatectomy, Physiotherapy
Eligibility Criteria
Inclusion Criteria:
- patients over 18 years
- diagnosed with localized or locally advanced prostate cancer
- that are undergoing radical prostatectomy as treatment of the condition
- they are coming from Barretos or a nearby region or has logistics facilities to come to the Barretos Cancer Hospital to perform the followup
Exclusion Criteria:
- those with mental or physical problems that make it impossible to collect data or that may influence the recovery of continence postoperatively
- patients with metastatic prostate cancer
- patients not undergoing retropubic prostatectomy as treatment for prostate cancer
Sites / Locations
- Barretos Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control Group
group of pelvic floor exercises
anal electrostimulation group
Arm Description
in which patients received no specific treatment, only the usual general guidelines
in which patients were instructed to perform home exercises daily
in which patients, and are instructed to perform the exercises mentioned in the group of pelvic floor exercises, also underwent anal electrostimulation
Outcomes
Primary Outcome Measures
recovery of urinary continence
recovery of erectile function
Secondary Outcome Measures
evaluate prognosis for recovery of urinary continence
assess the presence of prognostic factors for the recovery of urinary continence after radical prostatectomy
Full Information
NCT ID
NCT02226237
First Posted
August 25, 2014
Last Updated
January 13, 2016
Sponsor
Barretos Cancer Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02226237
Brief Title
Effectiveness of Physiotherapy to Treat the Urinary Incontinence and Erectile Dysfunction Post Retropubic Prostatectomy
Official Title
URINARY INCONTINENCE AND ERECTIL DYSFUNCTION AFTER RADICAL PROSTATECTOMY: A Randomized Controlled Trial Comparing Pelvic Muscle Exercises With or Without Electrical Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barretos Cancer Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The prostate cancer is the most common parenchymal neoplasia in men over 45 years old. Radical prostatectomy is curative treatment is most used today. Urinary incontinence and erectile dysfunction are the main complications of radical prostatectomy. Physical therapy has been used as a form of conservative treatment of these complications. However, the role of physiotherapy in the treatment of these complications is not well defined in the literature. We will do a randomized controlled study with patients undergoing radical prostatectomy. After removal of the Foley catheter, patients will be randomized into 3 groups: control group, group of pelvic floor exercises and anal electrostimulation group. These patients will be evaluated preoperatively in an attempt to meet prognostic factors for urinary incontinence and erectile dysfunction. They will be followed by 2 years after surgery, to assess whether the therapy will alter the course of urinary continence and erectile function in these patients.
Detailed Description
Randomization was performed by a team of external statistics to the research team, using the method of randomization in blocks of three, who were randomly selected. The group to which the patient was allocated to researchers only be informed at the time of randomization, if patients satisfied the criteria for inclusion and exclusion.
Will be evaluated preoperatively: urodynamic studies and clinical evaluation. The following clinical data were evaluated: Body Mass Index (BMI), comorbidities, disease staging and sociodemographic information.
The following parameters will be evaluated in the pre-operative and after one, three, six and twelve months after surgery: evaluating the strength of the pelvic floor through perineometry, the 1 hour pad test, electromyographic evaluation of pelvic floor, and the application of instruments validated for the Portuguese language. The follow instruments will be applied: International Index of Erectile Function - 5 questions (IIEF-5), International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), International Prostate Symptom Score (IPSS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Erectile Dysfunction
Keywords
urinary incontinence, erectile dysfunction, Retropubic Prostatectomy, Physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
237 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
in which patients received no specific treatment, only the usual general guidelines
Arm Title
group of pelvic floor exercises
Arm Type
Experimental
Arm Description
in which patients were instructed to perform home exercises daily
Arm Title
anal electrostimulation group
Arm Type
Experimental
Arm Description
in which patients, and are instructed to perform the exercises mentioned in the group of pelvic floor exercises, also underwent anal electrostimulation
Intervention Type
Procedure
Intervention Name(s)
group of pelvic floor exercises
Intervention Description
contraction of the pelvic floor muscles sustained for 5 seconds, hip adductors using pillow and elevation of the hip, 30 repetitions of each exercise
Intervention Type
Procedure
Intervention Name(s)
anal electrostimulation group
Intervention Description
The anal electrical stimulation protocol was performed by a physical therapist for seven weeks, twice per week, using the apparatus Dualpex 961 Uro® Quark, with frequency of 35 Hz, and the intensity determined according to the tolerance of the patient, lasting 20 minutes.
Primary Outcome Measure Information:
Title
recovery of urinary continence
Time Frame
one year
Title
recovery of erectile function
Time Frame
two years
Secondary Outcome Measure Information:
Title
evaluate prognosis for recovery of urinary continence
Description
assess the presence of prognostic factors for the recovery of urinary continence after radical prostatectomy
Time Frame
one year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients over 18 years
diagnosed with localized or locally advanced prostate cancer
that are undergoing radical prostatectomy as treatment of the condition
they are coming from Barretos or a nearby region or has logistics facilities to come to the Barretos Cancer Hospital to perform the followup
Exclusion Criteria:
those with mental or physical problems that make it impossible to collect data or that may influence the recovery of continence postoperatively
patients with metastatic prostate cancer
patients not undergoing retropubic prostatectomy as treatment for prostate cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wesley J Magnabosco, MD
Organizational Affiliation
Barretos Cancer Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
João L Amaro, PhDh
Organizational Affiliation
UPECLIN HC FM Botucatu Unesp
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Carla LC Andrade
Organizational Affiliation
Barretos Cancer Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fernanda Jabur
Organizational Affiliation
Barretos Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barretos Cancer Hospital
City
Barretos
State/Province
São Paulo State
ZIP/Postal Code
14780000
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Physiotherapy to Treat the Urinary Incontinence and Erectile Dysfunction Post Retropubic Prostatectomy
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