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

NCT03188744 | Unknown DMC

• 1 other identifier: 5557/2017
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Cervical cancer; Pelvic floor muscles; Physiotherapy; Quality of life

Outcome Measures

Primary Outcomes (1)

• Pelvic floor muscles function

  Evaluated through vaginal palpation and perineometry.

  Four months

Secondary Outcomes (3)

• Quality of life in the pelvic floor muscles dysfunction.

  Four months

• Prevalence of the pelvic floor muscles dysfunction.

  Four months

• Overall quality of life.

  Four months

Study Arms (4)

Group 1

Patients with CC with PFMD.

Other: Assessment of the pelvic floor function; Other: Questionnaire application

Group 2

Patients with CC without PFMD.

Other: Assessment of the pelvic floor function; Other: Questionnaire application

Group 3

Patients without CC with PFMD.

Other: Assessment of the pelvic floor function; Other: Questionnaire application

Group 4

Patients without CC without PFMD.

Other: Assessment of the pelvic floor function; Other: Questionnaire application

Interventions

Assessment of the pelvic floor function OTHER

Vaginal palpation and perineometry.

Group 1; Group 2; Group 3; Group 4

Questionnaire application OTHER

Questionnaires: EORTC, WHOQoL-BREF, PFID-20; PSIQ-12 and PFIQ-7.

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women with CC with and without PFMD and women without CC with and without PFMD.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of São Paulo

Ribeirão Preto, São Paulo, 14040-900, Brazil

Location

Related Publications (4)

• 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. doi: 10.1002/cncr.22217.

  PMID: 16977652 BACKGROUND

• 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 Urogynecol J. 2016 Jul;27(7):1097-106. doi: 10.1007/s00192-015-2938-8. Epub 2016 Jan 19.

  PMID: 26782099 RESULT

• 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.

  PMID: 21796471 RESULT

• 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: 10.1111/j.1471-0528.2009.02411.x.

  PMID: 19874292 RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Officials

• Harley Oliveira, PhD

  University of Sao Paulo

  STUDY DIRECTOR

Central Study Contacts

Aline Ribeiro, MSc.

CONTACT

+5516981102877; alinemrib@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc.

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 15, 2017
• Study Start: January 2, 2019
• Primary Completion: March 1, 2019
• Study Completion: June 1, 2019
• Last Updated: December 20, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)