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

NCT ID: NCT02226237

Last Updated: 2016-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 237 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2015-12-31

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).

Conditions

Urinary Incontinence; Erectile Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

in which patients received no specific treatment, only the usual general guidelines

Group Type: NO_INTERVENTION

No interventions assigned to this group

group of pelvic floor exercises

in which patients were instructed to perform home exercises daily

Group Type: EXPERIMENTAL

group of pelvic floor exercises

Intervention Type: PROCEDURE

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

in which patients, and are instructed to perform the exercises mentioned in the group of pelvic floor exercises, also underwent anal electrostimulation

Group Type: EXPERIMENTAL

group of pelvic floor exercises

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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.

Interventions

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

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Barretos Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wesley Justino Magnabosco

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wesley J Magnabosco, MD

Role: PRINCIPAL_INVESTIGATOR

Barretos Cancer Hospital

João L Amaro, PhDh

Role: STUDY_DIRECTOR

UPECLIN HC FM Botucatu Unesp

Carla LC Andrade

Role: PRINCIPAL_INVESTIGATOR

Barretos Cancer Hospital

Fernanda Jabur

Role: PRINCIPAL_INVESTIGATOR

Barretos Cancer Hospital

Locations

Barretos Cancer Hospital

Barretos, São Paulo State, Brazil

Countries

Brazil

References

Johnson EE, Mamoulakis C, Stoniute A, Omar MI, Sinha S. Conservative interventions for managing urinary incontinence after prostate surgery. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD014799. doi: 10.1002/14651858.CD014799.pub2.

Reference Type: DERIVED

PMID: 37070660 (View on PubMed)

Other Identifiers

FSTXPTR2010

Identifier Type: -

Identifier Source: org_study_id