NCT02645136

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 muscular pressure strength of the pelvic floor as conservative treatment of urinary incontinence after prostatectomy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable prostate-cancer

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

January 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 1, 2016

Completed
Last Updated

January 1, 2016

Status Verified

December 1, 2015

Enrollment Period

1.2 years

First QC Date

December 27, 2015

Last Update Submit

December 30, 2015

Conditions

Prostate CancerUrinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

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

    baseline and 3 months

  • Change in Pad test 24 hours at 3 months

    baseline and 3 months

Study Arms (3)

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 (AES) associated with Pelvic Floor Muscle Training (PFMT), supervised by a specialized physiotherapist. All subjects received orientation to perform the same pelvic floor exercises at home.

Other: PFMT and AES

Control

PLACEBO COMPARATOR

Control Group

Other: Control

Interventions

PilatesOTHER

Pilates exercises

PILATES
PFMT and AESOTHER

conventional pelvic floor muscle exercises combined with anal electrical stimulation Device: electrical stimulation (Dualpex 961 Uro®)

PFMT and AES
ControlOTHER
Control

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 (2)

  • 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: 37070660DERIVED

  • Gomes CS, Pedriali FR, Urbano MR, Moreira EH, Averbeck MA, Almeida SHM. The effects of Pilates method on pelvic floor muscle strength in patients with post-prostatectomy urinary incontinence: A randomized clinical trial. Neurourol Urodyn. 2018 Jan;37(1):346-353. doi: 10.1002/nau.23300. Epub 2017 May 2.

    PMID: 28464434DERIVED

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

December 27, 2015

First Posted

January 1, 2016

Study Start

January 1, 2014

Primary Completion

April 1, 2015

Study Completion

July 1, 2015

Last Updated

January 1, 2016

Record last verified: 2015-12

Data Sharing

IPD Sharing
Will share