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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02226237
Other study ID # FSTXPTR2010
Secondary ID
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


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
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