NCT06839040 Effects of a Multidisciplinary Intervention on Fall Risk and Urinary Incontinence in Older Women
| NCT ID | NCT06839040 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundación Universidad Católica de Valencia San Vicente Mártir |
| Condition | Urinary Incontinence |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-02-03 |
| Primary Completion | 2025-12-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-02-03 with a primary completion date of 2025-12-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This will be a quantitative, quasi-experimental, and longitudinal study spanning 18 weeks of intervention, followed by a 24-week follow-up, scheduled to begin in January 2025. The primary objective of this study is to evaluate the effects of a multidisciplinary intervention comprising physiotherapy, physical exercise, and psychoeducation on fall risk and urinary incontinence in non-institutionalized older adult women aged 60 to 80 years. Participants will be randomly assigned to one of four groups: 1. A multicomponent exercise group with verbal instructions for pelvic floor exercises. 2. A multicomponent exercise group with verbal instructions for pelvic floor exercises and psychoeducation. 3. A multicomponent exercise group without verbal instructions for pelvic floor exercises. 4. A control group. Multicomponent exercise sessions will be conducted twice a week, while the psychoeducation group will participate in five group therapy sessions throughout the program. The variables to be analyzed include balance, strength, power, pelvic floor function, quality of life, and self-esteem.
Eligibility Criteria
Inclusion Criteria: * Woman, aged between 60 and 80 years. * Not having done physical exercise in the last 3 months. * Present UI (SUI, UUI or MUI) after clinical diagnosis. * Score greater than 90 on the Barthel Scale. * Not present pathologies or functional alterations that limit the practice of physical exercise. * Not present severe cognitive alterations or mild cognitive deficit (Global Deterioration Scale less than or equal to 2 or Mini Mental State Examination greater than or equal to 25 points). * Maintain walking without support products. * Carry out 80% of the total sessions Exclusion Criteria: * Intake of medication that could affect the performance of the exercise or alter the variables studied. * Present grade II-IV uterine prolapses. * Clinical disease or syndrome (chronic or acute cardiovascular, neurological, respiratory or musculoskeletal disorders) that may interfere with the performance of the intervention and evaluation. * Present visual and/or auditory alterations that make it difficult to carry out the intervention and evaluation.
Contact & Investigator
ESTHER RAMOS CASTELLANO
PRINCIPAL INVESTIGATOR
Escuela de Doctorado. Universidad Católica de Valencia San Vicente Mártir (Doctoral School. Catholic University of Valencia San Vicente Mártir)
Frequently Asked Questions
Who can join the NCT06839040 clinical trial?
This trial is open to female participants only, aged 60 Years or older, up to 80 Years, studying Urinary Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06839040 currently recruiting?
Yes, NCT06839040 is actively recruiting participants. Contact the research team at esther.ramos@ucv.es for enrollment information.
Where is the NCT06839040 trial being conducted?
This trial is being conducted at Valencia, Spain.
Who is sponsoring the NCT06839040 clinical trial?
NCT06839040 is sponsored by Fundación Universidad Católica de Valencia San Vicente Mártir. The principal investigator is ESTHER RAMOS CASTELLANO at Escuela de Doctorado. Universidad Católica de Valencia San Vicente Mártir (Doctoral School. Catholic University of Valencia San Vicente Mártir). The trial plans to enroll 120 participants.