NCT02086266

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Mar 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
Last Updated

March 13, 2014

Status Verified

March 1, 2014

Enrollment Period

2 years

First QC Date

March 9, 2014

Last Update Submit

March 11, 2014

Conditions

Keywords

ProstatectomyUrinary ContinencePhysical Therapy ModalitiesPelvic FloorRandomized Trial.

Outcome Measures

Primary Outcomes (1)

  • Change in the number of pads used per day at 3 months

    3 months

Secondary Outcomes (3)

  • Change in the 24 hours Pad Test at 3 months

    3 months

  • Change in the International Consultation of Urinary Incontinence- Short Form at 3 months

    3 months

  • Change in the episodes of nocturia at 3 months

    3 months

Study Arms (2)

PILATES

EXPERIMENTAL

Weekly Pilates sessions, guided by a specialized physiotherapist. The duration of the treatment was 10 weeks, and each session lasted 45 to 50 minutes. All subjects received instruction to perform specific daily home exercises.

Other: PILATES

PFMT and AES

ACTIVE COMPARATOR

For also 10 weeks, the participants went trough anal electrical stimulation associated with Pelvic Floor Muscle Training, supervised by a specialized physiotherapist. All subjects received orientation to perform the same pelvic floor exercises at home.

Other: PFMT and AES

Interventions

PILATESOTHER
PILATES
PFMT and AES

Eligibility Criteria

Age50 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteers between 50 and 75 years old;
  • Submitted to radical prostatectomy;
  • With complaints of urinary incontinence;
  • That completed one month of surgery;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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.

MeSH Terms

Conditions

Prostatic NeoplasmsUrinary Incontinence

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physioterapist student of a masters degree program at the Center of Health Science

Study Record Dates

First Submitted

March 9, 2014

First Posted

March 13, 2014

Study Start

March 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 13, 2014

Record last verified: 2014-03