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

Gynecologic Cancer Clinical Trial

— PPPVSSR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03090217
• Other study ID #: PP-radiotherapy 2017
• Status: Recruiting
• Phase: N/A
• First received: January 12, 2017
• Last updated: August 21, 2017
• Start date: August 21, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: August 2017
• Source: Federal University of Health Science of Porto Alegre
• Contact: Fabrício E. Macagnan, MD
• Phone: +55 (51)99374-1286
• Email: fmacagnan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: July 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Gynecologic Cancer
• Pathological Constriction

Intervention

Behavioral:
• Pelvic Physiotherapy
1) daily pelvic floor muscle training (PFMT).
• Standard care (SC)
1) daily vaginal dilator therapy (10 to 15 minutes) and 2) usual care management.

Locations

Country	Name	City	State
Brazil	Comitê de Ética em Pesquisa - Santa Casa de Misericórdia de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre	Irmandade Santa Casa de Misericórdia de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (66)

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* Note: There are 66 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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	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.
Secondary	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.
Secondary	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.