Clinical trial NCT02226237: 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
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Erectile Dysfunction
Keywords: urinary incontinence
erectile dysfunction
Retropubic Prostatectomy
Physiotherapy
Lead sponsor: Barretos Cancer Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2014-08-27
Enrollment: 237
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: recovery of urinary continence
timeFrame: one year
measure: recovery of erectile function
timeFrame: two years
Secondary outcomes:
measure: evaluate prognosis for recovery of urinary continence
timeFrame: one year
Other outcomes:
Locations:
city: Barretos
country: Brazil
facility: Barretos Cancer Hospital
state: São Paulo State
Study officials:
affiliation: Barretos Cancer Hospital
name: Wesley J Magnabosco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UPECLIN HC FM Botucatu Unesp
name: João L Amaro, PhDh
role: STUDY_DIRECTOR
affiliation: Barretos Cancer Hospital
name: Carla LC Andrade
role: PRINCIPAL_INVESTIGATOR
affiliation: Barretos Cancer Hospital
name: Fernanda Jabur
role: PRINCIPAL_INVESTIGATOR
References: