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Physiotherapy for Women After Gynecologic Pelvic Cancer Treatment.

Rehabilitation Program of Pelvic Floor Post-Surgery and Radiotherapy for Gynecological Pelvic Cancer: Randomized and Controlled Clinical Trial. - PFMT - Pelvic floor muscle training

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-97rb5wk
Enrollment
Unknown
Registered
2021-12-13
Start date
2022-02-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence

Interventions

An assistant researcher not involved in other stages of the research will randomize the participants into two groups: a control group and the intervention group. Randomization will be performed throug
E02.760.169.063.500.387

Sponsors

Faculdade de Medicina de Ribeirão Preto
Lead Sponsor
Centro de Pesquisa Oncologica
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age group older than 18 years; Clinical staging I to III of pelvic gynecological cancer; Having undergone surgery, radiotherapy, and/or brachytherapy; Have urinary incontinence; Do not present any orthopedic or neurological limitations that prevent the practice of the rehabilitation program; Not being under physiotherapeutic treatment.

Exclusion criteria

Exclusion criteria: Withdrawal of the informed consent form.

Design outcomes

Primary

MeasureTime frame
1. The primary outcome of the study is the prevalence of urinary incontinence assessed through the question "How often do you lose urine?" being: 0- never, 1- once a week at least, 2- two or three times a week, 3- once a day, 4- several times a day and 5- all the time from the “International Consultation on Incontinence” questionnaire Questionnaire - Short Form (ICIQ-SF)." It is expected to find an improvement in the prevalence of urinary incontinence in the intervention group compared to the control group.

Secondary

MeasureTime frame
2. The severity and impact of urinary incontinence on quality of life assessed by the questionnaire score "International Consultation on Incontinence Questionnaire – Short Form (ICIQ-SF)." and with that, a score that can range from 0 (when there is no report of urinary loss, with no impact on quality of life) and 21 greater impacts on quality of life and on the severity of urinary incontinence is obtained. 3. Sexual function assessed through the Female Sexual Function Index (FSFI) questionnaire, this questionnaire consists of 19 questions grouped into six areas: desire, excitement, lubrication, orgasm, satisfaction, and pain. The sexual function score at the end of the analysis can range from 2 to 36 points, and the higher the score obtained, the better the woman's sexual function. 4. Dyspareunia will be used as the score on the numerical scale from 0 to 10 where the end of the scale, "no pain" and the other "worst imaginable pain". 5. Self-esteem will be assessed by the Rosemberg self-esteem scale, the total score varies from 10 to 40 points, it is understood that the higher the value reached by the woman on the scale, the better her self-esteem. 6. Pain will be used to score the numerical scale from 0 to 10, where the ends of the scale "no pain" and the other "worst imaginable pain" and its location by a diagram of the body to identify the topography of pain. 7. Anal incontinence will be assessed by the Fecal Incontinence Quality of Life (FIQL) questionnaire, this questionnaire contains 29 questions, which allow the calculation of impact scores on quality of life in four scales: lifestyle, behavior, depression, and embarrassment. The lower the score on each scale, whose score can range from 1 to 5, the lower the functional status of quality of life. 8. The consistency of the stools will be according to the Bristol scale. 9. Vaginal stenosis by means of vaginal dilators containing 8 dilators, the smallest dilator has a diameter of 1.0 cm and length 6.5 cm an

Countries

Brazil

Contacts

Public ContactTatiana Fretta
tatibem@hotmail.com+55(48)996157966

Outcome results

None listed

Source: REBEC (via WHO ICTRP)