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

• Conditions: Surgery; Radiotherapy; Complications; Cervical Cancer; Pelvic Floor Disorders; Chemotherapy Effect
• Interventions: Other: Assessment of the pelvic floor function; Other: Questionnaire application

• Registration Number: NCT03188744
• Lead Sponsor: University of Sao Paulo

Brief Summary

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-06-12
• Study First Submitted QC: 2017-06-14
• Study First Posted: 2017-06-15
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-18
• Last Update Posted: 2018-12-20
• Study Start: 2019-01-02
• Primary Completion: 2019-03-01
• Study Completion: 2019-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 3	Questionnaire application	Patients without CC with PFMD.
Group 4	Questionnaire application	Patients without CC without PFMD.
Group 1	Questionnaire application	Patients with CC with PFMD.
Group 2	Assessment of the pelvic floor function	Patients with CC without PFMD.
Group 3	Assessment of the pelvic floor function	Patients without CC with PFMD.
Group 1	Assessment of the pelvic floor function	Patients with CC with PFMD.
Group 2	Questionnaire application	Patients with CC without PFMD.
Group 4	Assessment of the pelvic floor function	Patients without CC without PFMD.

Primary Outcome Measures

Name	Time	Method
Pelvic floor muscles function	Four months	Evaluated through vaginal palpation and perineometry.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of São Paulo; 🇧🇷 Ribeirão Preto, São Paulo, Brazil