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

NCT02226237 | Completed

• 1 other identifier: FSTXPTR2010
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence; Erectile Dysfunction

Keywords

urinary incontinence; erectile dysfunction; Retropubic Prostatectomy; Physiotherapy

Outcome Measures

Primary Outcomes (2)

• recovery of urinary continence

  one year

• recovery of erectile function

  two years

Secondary Outcomes (1)

• evaluate prognosis for recovery of urinary continence

  one year

Study Arms (3)

Control Group

NO INTERVENTION

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

group of pelvic floor exercises

EXPERIMENTAL

in which patients were instructed to perform home exercises daily

Procedure: group of pelvic floor exercises

anal electrostimulation group

EXPERIMENTAL

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

Procedure: group of pelvic floor exercises; Procedure: anal electrostimulation group

Interventions

group of pelvic floor exercises 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; group of pelvic floor exercises

anal electrostimulation group 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.

anal electrostimulation group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barretos Cancer Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Barretos Cancer Hospital

Barretos, São Paulo State, 14780000, Brazil

Location

Related Publications (1)

• 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.

  PMID: 37070660 DERIVED

MeSH Terms

Conditions

Urinary Incontinence; Erectile Dysfunction

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases, Male; Genital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Wesley J Magnabosco, MD

  Barretos Cancer Hospital

  PRINCIPAL INVESTIGATOR

• João L Amaro, PhDh

  UPECLIN HC FM Botucatu Unesp

  STUDY DIRECTOR

• Carla LC Andrade

  Barretos Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Fernanda Jabur

  Barretos Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 25, 2014
• First Posted: August 27, 2014
• Study Start: September 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 14, 2016

Record last verified: 2016-01

Locations

BR (1)