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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03188744
• Other study ID #: 5557/2017
• Status: Not yet recruiting
• Start date: January 2, 2019
• Est. completion date: June 1, 2019

Study information

• Verified date: December 2018
• Source: University of Sao Paulo
• Contact: Aline Ribeiro, MSc.
• Phone: +5516981102877
• Email: alinemrib[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Chemotherapy Effect
• Pelvic Floor Disorders
• Radiotherapy; Complications
• Surgery
• Uterine Cervical Neoplasms

Intervention

Other:
• Assessment of the pelvic floor function
Vaginal palpation and perineometry.
• Questionnaire application
Questionnaires: EORTC, WHOQoL-BREF, PFID-20; PSIQ-12 and PFIQ-7.

Locations

Country	Name	City	State
Brazil	University of São Paulo	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Arouca MA, Duarte TB, Lott DA, Magnani PS, Nogueira AA, Rosa-E-Silva JC, Brito LG. Validation and cultural translation for Brazilian Portuguese version of the Pelvic Floor Impact Questionnaire (PFIQ-7) and Pelvic Floor Distress Inventory (PFDI-20). Int Ur — View Citation

Greimel ER, Kuljanic Vlasic K, Waldenstrom AC, Duric VM, Jensen PT, Singer S, Chie W, Nordin A, Bjelic Radisic V, Wydra D; European Organization for Research and Treatment of Cancer Quality-of-Life Group. The European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life questionnaire cervical cancer module: EORTC QLQ-CX24. Cancer. 2006 Oct 15;107(8):1812-22. — View Citation

Hazewinkel MH, Sprangers MA, Taminiau-Bloem EF, van der Velden J, Burger MP, Roovers JP. Reasons for not seeking medical help for severe pelvic floor symptoms: a qualitative study in survivors of gynaecological cancer. BJOG. 2010 Jan;117(1):39-46. doi: 10 — View Citation

Santana GW, Aoki T, Auge AP. The Portuguese validation of the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int Urogynecol J. 2012 Jan;23(1):117-21. doi: 10.1007/s00192-011-1505-1. Epub 2011 Jul 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pelvic floor muscles function	Evaluated through vaginal palpation and perineometry.	Four months
Secondary	Quality of life in the pelvic floor muscles dysfunction.	Evaluated through application of the questionnaire PFIQ-7.	Four months
Secondary	Prevalence of the pelvic floor muscles dysfunction.	Evaluated through application of the questionnaires PSIQ-12 and PFID-20.	Four months
Secondary	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