NCT03090217

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

Pelvic Physiotherapy in the Prevention of Vaginal Stenosis Secondary to Radiotherapy of Gynecological Cancer: a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Federal University of Health Science of Porto Alegre · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Gynecologic Cancer
• Pathological Constriction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-08-21
• Primary completion: 2018-05-31
• Completion: 2018-07-31
• First posted: 2017-03-24
• Last updated: 2017-08-22

Locations

1 site across 1 country: Brazil