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

Not Applicable

Completed

• Conditions: Erectile Dysfunction; Urinary Incontinence
• Interventions: Procedure: group of pelvic floor exercises; Procedure: anal electrostimulation group

• Registration Number: NCT02226237
• Lead Sponsor: Barretos Cancer Hospital

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).

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2014-08-25
• Study First Submitted QC: 2014-08-25
• Study First Posted: 2014-08-27
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-13
• Last Update Posted: 2016-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 237

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group of pelvic floor exercises	group of pelvic floor exercises	in which patients were instructed to perform home exercises daily
anal electrostimulation group	group of pelvic floor exercises	in which patients, and are instructed to perform the exercises mentioned in the group of pelvic floor exercises, also underwent anal electrostimulation
anal electrostimulation group	anal electrostimulation group	in which patients, and are instructed to perform the exercises mentioned in the group of pelvic floor exercises, also underwent anal electrostimulation

Primary Outcome Measures

Name	Time	Method
recovery of urinary continence	one year
recovery of erectile function	two years

Secondary Outcome Measures

Name	Time	Method
evaluate prognosis for recovery of urinary continence	one year	assess the presence of prognostic factors for the recovery of urinary continence after radical prostatectomy

Trial Locations

Locations (1)

Barretos Cancer Hospital; 🇧🇷 Barretos, São Paulo State, Brazil