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Pelvic Physiotherapy in the Prevention of Vaginal Stenosis Secondary to the Radiotherapy

NCT03090217 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2017-08-22

No results posted yet for this study

Summary

Vaginal stenosis is one of the most prevalent side effects of pelvic radiation, affecting about one third of women. In this randomized controlled trial, the effect of a pelvic physiotherapy protocol on an incidence rate of vaginal stenosis in women with gynecological cancer undergoing gynecological brachytherapy. In addition, the investigators will explore an improvement in quality of life, sexuality, and contractile function of the pelvic floor muscles.

Conditions

  • Gynecologic Cancer
  • Pathological Constriction

Interventions

BEHAVIORAL

Pelvic Physiotherapy

1\) daily pelvic floor muscle training (PFMT).

BEHAVIORAL

Standard care (SC)

1\) daily vaginal dilator therapy (10 to 15 minutes) and 2) usual care management.

Sponsors & Collaborators

  • Irmandade Santa Casa de Misericórdia de Porto Alegre

    collaborator OTHER

  • Federal University of Health Science of Porto Alegre

    lead OTHER

Principal Investigators

  • Taís M Cerentini, Bela. · Federal University of Health Science of Porto Alegre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-21
Primary Completion
2018-05-31
Completion
2018-07-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03090217 on ClinicalTrials.gov