NCT02226237

Effectiveness of Physiotherapy to Treat the Urinary Incontinence and Erectile Dysfunction Post Retropubic Prostatectomy

URINARY INCONTINENCE AND ERECTIL DYSFUNCTION AFTER RADICAL PROSTATECTOMY: A Randomized Controlled Trial Comparing Pelvic Muscle Exercises With or Without Electrical Stimulation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 237 (actual)
• Sponsor: Barretos Cancer Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Urinary Incontinence
• Erectile Dysfunction

Interventions

Type	Name	Description
PROCEDURE	group 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
PROCEDURE	anal 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.

Timeline

• Start date: 2010-09-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-08-27
• Last updated: 2016-01-14

Locations

1 site across 1 country: Brazil