The Efficacy of Pilates in the Recovery of Post-prostatectomy Urinary Incontinence

Prostate Cancer Clinical Trial

Official title:

The Efficacy of Pilates Compared to Pelvic Floor Muscle Training Associated With Electrical Stimulation in the Recovery of Post-prostatectomy Urinary Incontinence: a Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02086266
• Other study ID #: PILUI1
• Status: Completed
• Phase: N/A
• First received: March 9, 2014
• Last updated: March 11, 2014
• Start date: March 2012
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: Universidade Estadual de Londrina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy between a Pilates exercise program and a Pelvic Floor Muscle Training (PFMT) protocol combined with anal electrical stimulation (AES) in the recovery of urinary continence (UI) after radical prostatectomy.

There are no studies that evaluate Pilates mat exercises for incontinence in men although it can be assured that this method has the pelvic floor contractions as a principle for practice. If this new therapeutic approach proves to be as effective as described treatment in improving urinary complaints, it will be an option for patients who prefer a non-invasive treatment.

Description:

This randomized clinical trial includes 69 individuals with urinary incontinence one month after radical prostatectomy. One physiotherapist, with experience in urogynecology, was responsible for all the assessments. Urinary frequency, nocturia, 24-hour pad test, number of pads used per day, and the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) were the variables evaluated.

The subjects were allocated in one of two treatment groups (G1: Pilates; G2: anal electrical stimulation combined with pelvic floor muscle training). Volunteers participated of 10 sessions of the corresponding treatment and were reassessed objectively by the number of pads used per day, and subjectively with the score of quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• Volunteers between 50 and 75 years old;

• Submitted to radical prostatectomy;

• With complaints of urinary incontinence;

• That completed one month of surgery;

Exclusion Criteria:

• History of incontinence;

• Transurethral resection of the prostate;

• Diagnosis of neurological or cognitive impairment;

• Subjects who were unable to attend treatment sessions, due to distance or physical limitations.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Urinary Incontinence

Intervention

Other:
• PILATES

• PFMT and AES

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Estadual de Londrina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the number of pads used per day at 3 months		3 months	Yes
Secondary	Change in the 24 hours Pad Test at 3 months		3 months	Yes
Secondary	Change in the International Consultation of Urinary Incontinence- Short Form at 3 months		3 months	Yes
Secondary	Change in the episodes of nocturia at 3 months		3 months	Yes