Pelvic Physiotherapy in the Prevention of Vaginal Stenosis Secondary to the Radiotherapy (NCT03090217) | Clinical Trial Compass
UnknownNot Applicable
Pelvic Physiotherapy in the Prevention of Vaginal Stenosis Secondary to the Radiotherapy
Brazil160 participantsStarted 2017-08-21
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Vaginal Stenosis
Timeframe: With completion of the study, predicted 15 months after the start of the study.
Trial details
NCT IDNCT03090217
SponsorFederal University of Health Science of Porto Alegre