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

NCT03090217 | Unknown

• 1 other identifier: PP-radiotherapy 2017
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Radiotherapy; Brachytherapy; Physiotherapy; Vaginal dilators; Pelvic floor exercises; Vaginal Stenosis

Outcome Measures

Primary Outcomes (1)

• Vaginal Stenosis

  Vaginal stenosis will be evaluated before the first brachytherapy and twelve months after. Considered according to the study of Kirchheiner et al., (2016) that used the Common Terminology Criteria for Adverse Events (CTCAE v3.0). Vaginal stenosis will also be considered as the narrowing of the vaginal canal that makes it impossible to introduce the number 1 acrylic gynecological speculum through the vaginal introitus.

  With completion of the study, predicted 15 months after the start of the study.

Secondary Outcomes (3)

• Quality of life

  With completion of the study, predicted 15 months after the start of the study.

• Sexuality

  With completion of the study, predicted 15 months after the start of the study.

• Muscle activity and contractile function of the pelvic floor

  With completion of the study, predicted 15 months after the start of the study.

Other Outcomes (1)

• The vaginal area

  With completion of the study, predicted 15 months after the start of the study.

Study Arms (2)

Pelvic physiotherapy (PP)

EXPERIMENTAL

Pelvic Physiotherapy include daily pelvic floor muscle training (PFMT). PFMT starts at first session of the brachytherapy and will be conduced during the twelve weeks treatment.

Behavioral: Pelvic Physiotherapy; Behavioral: Standard care (SC)

Stander Care (SC)

ACTIVE COMPARATOR

The stander care (SC) includes a guideline for gynecological cancer patients under radiotherapy/brachytherapy: 1) daily vaginal dilator therapy (10 to 15 minutes); and 2) usual care management. This SC starts at first session of the brachytherapy and will be conduced during the twelve weeks treatment.

Behavioral: Standard care (SC)

Interventions

Pelvic Physiotherapy BEHAVIORAL

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

Also known as: PFMT

Pelvic physiotherapy (PP)

Standard care (SC) BEHAVIORAL

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

Also known as: SC

Pelvic physiotherapy (PP); Stander Care (SC)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women over 18 years old;
• No vaginal stenosis at first evaluation;
• Women free of previous intracavitary radiation;
• Women diagnosed with gynecological cancer who are undergoing brachytherapy treatment during the period of research at the Santa Rita Hospital of the Santa Casa de Misericórdia in Porto Alegre;
• Women who agree to participate in the research through the Informed Consent Form (TCLE).

You may not qualify if:

• Women who do not sign the ICF;
• Women not being treated for gynecological cancer;
• Women who have a 30% lack of physical therapy sessions (4 sessions);
• Women who present complications that prevent the accomplishment of the protocol of pelvic physiotherapy or that do not perform all the treatment with brachytherapy.

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead
• Irmandade Santa Casa de Misericórdia de Porto Alegre: collaborator

Study Sites (1)

Comitê de Ética em Pesquisa - Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

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MeSH Terms

Conditions

Constriction, Pathologic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Taís M Cerentini, Bela.

  Federal University of Health Science of Porto Alegre

  STUDY CHAIR

Central Study Contacts

Fabrício E. Macagnan, MD

CONTACT

+55 (51)99374-1286; fmacagnan@gmail.com

Patrícia V da Rosa, MD

CONTACT

5551982292289; patriciarosa@ufcspa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: March 24, 2017
• Study Start: August 21, 2017
• Primary Completion: May 31, 2018
• Study Completion: July 31, 2018
• Last Updated: August 22, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)