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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02226237
• Other study ID #: FSTXPTR2010
• Status: Completed
• Phase: N/A
• First received: August 25, 2014
• Last updated: January 13, 2016
• Start date: September 2010
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Barretos Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction
• Urinary Incontinence

Intervention

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
• 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.

Locations

Country	Name	City	State
Brazil	Barretos Cancer Hospital	Barretos	São Paulo State

Sponsors (2)

Lead Sponsor	Collaborator
Barretos Cancer Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recovery of urinary continence		one year	No
Primary	recovery of erectile function		two years	No
Secondary	evaluate prognosis for recovery of urinary continence	assess the presence of prognostic factors for the recovery of urinary continence after radical prostatectomy	one year	No