The Effects of Pilates in Muscle Strength of the Pelvic Floor as Treatment of Post Prostatectomy Urinary Incontinence

Prostate Cancer Clinical Trial

Official title:

The Effects of Pilates Method in Muscle Strength of the Pelvic Floor as Treatment of Post Prostatectomy Urinary Incontinence: : a Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02645136
• Other study ID #: 820.529
• Status: Completed
• Phase: N/A
• First received: December 27, 2015
• Last updated: December 30, 2015
• Start date: January 2014
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• 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 muscular pressure strength of the pelvic floor as conservative treatment of urinary incontinence after prostatectomy.

Description:

This randomized clinical trial includes 115 individuals with urinary incontinence one month after radical prostatectomy. One physiotherapist, with experience in urogynecology, was responsible for all the assessments. muscular pressure strength of the pelvic floor, 24-hour pad test and the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) were the variables evaluated.

The subjects were allocated in one of three treatment groups (G1: Pilates; G2: anal electrical stimulation combined with pelvic floor muscle training and G3: Control Group).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: July 2015
• Est. primary completion date: April 2015
• 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, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Urinary Incontinence

Intervention

Other:
• Pilates
Pilates exercises
• PFMT and AES
conventional pelvic floor muscle exercises combined with anal electrical stimulation Device: electrical stimulation (Dualpex 961 Uro®)
• Control

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	improves muscle strength of the pelvic floor at 3 months	Evaluation of the contraction capacity of the pelvic floor using perineometer (Myomed 932 Enraf/Nonius®)	baseline and 3 months	Yes
Secondary	Change in the International Consultation of Urinary Incontinence- Short Form questionnaire at 3 months		baseline and 3 months	Yes
Secondary	Change in Pad test 24 hours at 3 months		baseline and 3 months	Yes