Pelvic Physiotherapy in the Prevention of Vaginal Stenosis Secondary to the Radiotherapy (PPPVSSR)

Federal University of Health Science of Porto Alegre

Status: Unknown

Conditions: Pathological Constriction; Gynecologic Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03090217

PP-radiotherapy 2017

Details and patient eligibility

About

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.

Full description

Tis study will be conducing in a reference hospital to oncology treatment were mane patients with gynecologic cancer are management on radiotherapy services. The aim of this work is evaluated the effects of the pelvic physiotherapy (PP) on the more prevalent constriction pathology (vaginal stenosis) secondary to the brachytherapy. The PP will be conduced by three months after the radiotherapy starts and the incidence of the vaginal stenosis will be compared with a control group throughout six months of fallow-up.

Enrollment: 160 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Pelvic physiotherapy (PP)

Experimental group

Description:

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.

Treatment:

Behavioral: Standard care (SC)

Behavioral: Pelvic Physiotherapy

Stander Care (SC)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard care (SC)