MedTrace Logo

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

NCT03188744 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2018-12-20

No results posted yet for this study

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

Interventions

OTHER

Assessment of the pelvic floor function

Vaginal palpation and perineometry.

OTHER

Questionnaire application

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

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Harley Oliveira, PhD · University of Sao Paulo

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-02
Primary Completion
2019-03-01
Completion
2019-06-01

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03188744 on ClinicalTrials.gov