Impact of Cancer Treatment on the Pelvic Floor Function in Survivors of Cervical Cancer

Study Overview
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Brief Summary
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Introduction: Pelvic floor muscle dysfunctions (PFMD) represent an important public health problem that manifests itself through lower urinary tract symptoms (LUTS), anorectal and sexual dysfunction. PFMD is a common problem in cervical cancer survivors (CC) with a negative impact on quality of life (QoL). Objective: This study aims to evaluate the effect of oncological treatment on the function of pelvic floor muscles (PFM) of survivors of CC. Methods: Patients diagnosed with CC, of any stage, histology and degree, accompanied by the Oncology Gynecology Service of the Hospital das Clínicas of the Medical School of Ribeirão Preto at the University of São Paulo, will be studied in the period between 2004 and 2014. Four study groups will be formed: (1) Patients with CC with PFMD; (2) Patients with CC without PFMD; : (3) Patients without CC with PFMD; (2) Patients without CC without PFMD. Non-cancer patients will be recruited into the community. For the analysis of the prevalence of PFMD will be applied to the discomfort Questionnaire on pelvic floor (IDPE-20) for evaluation of pelvic organ prolapse (POP) complaints, anorectal symptoms and urinary incontinence, and the Sexual Questionnaire for urinary incontinence and pelvic organ prolapse (PISQ -12) for evaluation of sexual function. Both questionnaires have already been validated for the Portuguese language and are specific for women with PFMD. The pelvic floor impact questionnaire (PFIQ-7) will also be applied to assess the impact of PFMD on quality of life, daily living activities and emotional health. For the evaluation of general QOL, the EORTC questionnaire QLQ-C30 and its specific module for patients with CC, QLQ-CX24 will be used. The evaluation of PFM function will include vaginal palpation (Modified Oxford Scale) and perineometry (Peritron).

Official Title
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Impact of Cancer Treatment on the Pelvic Floor Function in Survivors of Cervical Cancer

Conditions
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Radiotherapy; Complications, Chemotherapy Effect, Cervical Cancer, Pelvic Floor Disorders, Surgery

Intervention / Treatment
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* Other: Assessment of the pelvic floor function
* Other: Questionnaire application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women diagnosed with CC; No distinction as to age, race, scholarity and religion; Women in follow-up at Clinical Hospital of Medical School of Ribeirão Preto of University São Paulo. Exclusion Criteria: Women who did not complete the proposed cancer treatment; Women who presented CC as the second malignant neoplasm; Pregnant women; Failure to respond to the proposed questionnaires.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Patients with CC with PFMD. | Other: Assessment of the pelvic floor function<br>* Vaginal palpation and perineometry.<br>Other: Questionnaire application<br>* Questionnaires: EORTC, WHOQoL-BREF, PFID-20; PSIQ-12 and PFIQ-7.<br>|
| Group 2<br>Patients with CC without PFMD. | Other: Assessment of the pelvic floor function<br>* Vaginal palpation and perineometry.<br>Other: Questionnaire application<br>* Questionnaires: EORTC, WHOQoL-BREF, PFID-20; PSIQ-12 and PFIQ-7.<br>|
| Group 3<br>Patients without CC with PFMD. | Other: Assessment of the pelvic floor function<br>* Vaginal palpation and perineometry.<br>Other: Questionnaire application<br>* Questionnaires: EORTC, WHOQoL-BREF, PFID-20; PSIQ-12 and PFIQ-7.<br>|
| Group 4<br>Patients without CC without PFMD. | Other: Assessment of the pelvic floor function<br>* Vaginal palpation and perineometry.<br>Other: Questionnaire application<br>* Questionnaires: EORTC, WHOQoL-BREF, PFID-20; PSIQ-12 and PFIQ-7.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic floor muscles function | Evaluated through vaginal palpation and perineometry. | Four months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life in the pelvic floor muscles dysfunction. | Evaluated through application of the questionnaire PFIQ-7. | Four months | 
| Prevalence of the pelvic floor muscles dysfunction. | Evaluated through application of the questionnaires PSIQ-12 and PFID-20. | Four months | 
| Overall quality of life. | Evaluated through application of the questionnaires EORTC QLQ-C30 and its specific module for patients with CC, QLQ-CX24 and the WHOQoL-BREF questionnaire. | Four months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical cancer, Pelvic floor muscles, Physiotherapy, Quality of life