Cervical CancerNCT03188744
Impact of Cancer Treatment on the Pelvic Floor Function in Survivors of Cervical Cancer
An observational study of Cervical Cancer and Pelvic Floor Disorders, run by University of Sao Paulo at 1 site in Brazil.
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). Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Pelvic Floor Disorders, Surgery
- What is being tested?
- Assessment of the pelvic floor function and Questionnaire application
- How many people
- 150 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jan 2019to 1 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women with CC with and without PFMD and women without CC with and without PFMD.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of São Paulo
Ribeirão Preto, São Paulo, 14040-900
Aline Ribeiro, MSc, +55 35 998378748, alinemrib@gmail.com
Aline Ribeiro, MSc
About this study
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
- Being tested
- Assessment of the pelvic floor function, Questionnaire application
- Keywords
- Cervical cancer, Pelvic floor muscles, Physiotherapy, Quality of life
- Medical subject headings
- Uterine Cervical Neoplasms, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of the pelvic floor functionOther
Vaginal palpation and perineometry.
Questionnaire applicationOther
Questionnaires: EORTC, WHOQoL-BREF, PFID-20; PSIQ-12 and PFIQ-7.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with CC with PFMD. Receives: Other: Assessment of the pelvic floor function; Other: Questionnaire application | |
| Group 2 | Patients with CC without PFMD. Receives: Other: Assessment of the pelvic floor function; Other: Questionnaire application | |
| Group 3 | Patients without CC with PFMD. Receives: Other: Assessment of the pelvic floor function; Other: Questionnaire application | |
| Group 4 | Patients without CC without PFMD. Receives: Other: Assessment of the pelvic floor function; Other: Questionnaire application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic floor muscles function
Evaluated through vaginal palpation and perineometry.
Measured: Four months
Secondary outcomes (3)
Quality of life in the pelvic floor muscles dysfunction.
Evaluated through application of the questionnaire PFIQ-7.
Measured: Four months
Prevalence of the pelvic floor muscles dysfunction.
Evaluated through application of the questionnaires PSIQ-12 and PFID-20.
Measured: 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.
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start2 Jan 2019 (estimated)
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aline Moreira Ribeiro, University of Sao Paulo
- Investigators
- Harley Oliveira, PhD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188744
- Sponsor's protocol ID
- 5557/2017
- Status last verified
- Dec 2018
- First submitted
- 12 Jun 2017
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16977652Arouca 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.
PubMed 26782099Santana 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.
PubMed 21796471Hazewinkel 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.
PubMed 19874292
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cancer Treatment on the Pelvic Floor Function in Survivors of Cervical Cancer
- ClinicalTrials.gov ID
- NCT03188744
- Acronym / sponsor ID
- 5557/2017
- Conditions
- Cervical Cancer, Pelvic Floor Disorders, Surgery, Radiotherapy; Complications, Chemotherapy Effect
- Keywords
- Cervical cancer, Pelvic floor muscles, Physiotherapy, Quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 2 Jan 2019 (estimated)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 15 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Assessment of the pelvic floor function, Other: Questionnaire applicationPatients with CC with PFMD. |
| Group 2 | – | Other: Assessment of the pelvic floor function, Other: Questionnaire applicationPatients with CC without PFMD. |
| Group 3 | – | Other: Assessment of the pelvic floor function, Other: Questionnaire applicationPatients without CC with PFMD. |
| Group 4 | – | Other: Assessment of the pelvic floor function, Other: Questionnaire applicationPatients without CC without PFMD. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women with CC with and without PFMD and women without CC with and without PFMD.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of the pelvic floor functionVaginal palpation and perineometry. | Other | Group 1, Group 2, Group 3, Group 4 |
| Questionnaire applicationQuestionnaires: EORTC, WHOQoL-BREF, PFID-20; PSIQ-12 and PFIQ-7. | Other | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Pelvic floor muscles function
Time frame: Four months
Evaluated through vaginal palpation and perineometry.
3 secondary outcomes
Quality of life in the pelvic floor muscles dysfunction.
Time frame: Four months
Prevalence of the pelvic floor muscles dysfunction.
Time frame: Four months
Overall quality of life.
Time frame: Four months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
- Background: PubMed 16977652Greimel 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.
- Results publication: PubMed 26782099Arouca 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.
- Results publication: PubMed 21796471Santana 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.
- Results publication: PubMed 19874292Hazewinkel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harley Oliveira, PhD study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and Pelvic Floor Disorders, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aline Ribeiro, MSc. (+5516981102877, alinemrib@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic floor muscles function (time frame: Four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03188744, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2018.