Erectile Dysfunction, Urinary Incontinence
Conditions
Keywords
urinary incontinence, erectile dysfunction, Retropubic Prostatectomy, Physiotherapy
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).
Interventions
PROCEDUREgroup of pelvic floor exercises
contraction of the pelvic floor muscles sustained for 5 seconds, hip adductors using pillow and elevation of the hip, 30 repetitions of each exercise
PROCEDUREanal electrostimulation group
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.
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
Barretos Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recovery of urinary continence | one year |
| recovery of erectile function | two years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| evaluate prognosis for recovery of urinary continence | one year | assess the presence of prognostic factors for the recovery of urinary continence after radical prostatectomy |
Countries
Brazil
Outcome results
None listed