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| Name | Class |
|---|---|
| Irmandade Santa Casa de Misericórdia de Porto Alegre | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic Physiotherapy | Behavioral | 1) daily pelvic floor muscle training (PFMT). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | The quality of live will be evaluated before the first brachytherapy and twelve months after through the application of the Quality of Life questionnaire European Organization for Research and Treatment of Cancer - EORTC QLQ-C30. | With completion of the study, predicted 15 months after the start of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| The vaginal area | The vaginal area will be evaluated before the first brachytherapy and twelve months after through A-SÒS-labeled vaginal dilators in eight different sizes in square centimeters and the vaginal length will be measured with a hysterometer, introduced into the vaginal canal until it reaches the cervix (from the himenal ring to the Posterior fornice), the measurement will be in centimeters. | With completion of the study, predicted 15 months after the start of the study. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabrício E. Macagnan, MD | Contact | +55 (51)99374-1286 | cel | fmacagnan@gmail.com |
| Patrícia V da Rosa, MD | Contact | 5551982292289 | cel | patriciarosa@ufcspa.edu.br |
| Name | Affiliation | Role |
|---|---|---|
| Taís M Cerentini, Bela. | Federal University of Health Science of Porto Alegre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comitê de Ética em Pesquisa - Santa Casa de Misericórdia de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | ABHINAV, KR et al. Analysis of Late Radiation Proctitis Among Patients Treated for Cervical Cancer: A Comparative Study Between Linear Accelerator and Cobalt Teletherapy. Clinical Ovarian and Other Gynecologic Cancer, 6(1): 46-49, 2013. | ||
| 19539646 | Background | Auchincloss CC, McLean L. The reliability of surface EMG recorded from the pelvic floor muscles. J Neurosci Methods. 2009 Aug 30;182(1):85-96. doi: 10.1016/j.jneumeth.2009.05.027. Epub 2009 Jun 17. | |
| 21300451 |
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If shared, available after the end of the study through email taismcerentini@gmail.com
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| ID | Term |
|---|---|
| D003251 | Constriction, Pathologic |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard care (SC) | Behavioral | 1) daily vaginal dilator therapy (10 to 15 minutes) and 2) usual care management. |
|
|
| Sexuality |
The sexuality will be evaluated before the first brachytherapy and twelve months after through the application of the questionnaire The Female Sexual Function Index (FSFI). |
| With completion of the study, predicted 15 months after the start of the study. |
| Muscle activity and contractile function of the pelvic floor | Measurement of pelvic floor activity will be evaluated before the first brachytherapy and twelve months after through surface electromyography (EMG), which is able to record the extracellular bioelectric activity generated by muscle fibers, through the electromyographic biofeedback Miotool 400 from Miotec. | With completion of the study, predicted 15 months after the start of the study. |
| Background |
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