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Tele Rehabilitation for Women with Urinary Incontinence after Gynecological Pelvic Cancer Treatment.

Tele Rehabilitation Program of the Pelvic Floor in Women with Urinary Incontinence After Surgery, Radiotherapy and/or Brachytherapy for Gynecological Pelvic Cancer: Randomized and Controlled Clinical Trial.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-8ht5nqq
Enrollment
Unknown
Registered
2022-01-26
Start date
2022-03-10
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: control group and intervention group. Randomization will be performed through a co
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)"

Secondary

MeasureTime frame
14. Participants in the experimental group will join the supervised sessions and adverse effects during the intervention will be recorded through a diary by the researcher.;15. In order to verify the usability of the system used, the experimental group after the 12 weeks of intervention will answer the System Usability Scale (SUS) instrument. The instrument contains ten questions and generates a single score on an easy-to-understand scale, making it possible to classify the evaluated system.;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).”;3. Sexual function assessed by the total score of the domains of the Female Sexual Function Index questionnaire (FSFI).;4. Dyspareunia will be used 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. Anal incontinence assessed by the Fecal Incontinence Quality of Life questionnaire (FIQL).;6. Stool consistency by the Bristol Stool Consistency Scale.;7. Self-esteem assessed by the Rosenberg self-esteem scale questionnaire.;8. Location of pain marked on a diagram of the body and perception of pain intensity 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.";9. Report of vaginal stenosis will be evaluated by the classification of stenosis Common Terminology Criteria for Adverse Events v.4.0 9 (CTCAE).;10. Quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30).;11. Physical activity levels assessed by the International Physical Activity Questionnaire (IPAQ - short version).;12. After the 12 weeks of intervention, the experimental group will answer how satisfied they were with the treatment through the scale on a numerical scale from 0 to 10, where the ends of

Countries

Brazil

Contacts

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

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 2, 2026