Urinary IncontinenceFIRE-WOMENNCT06839040
Effects of a Multidisciplinary Intervention on Fall Risk and Urinary Incontinence in Older Women
A study testing Group 1: ExVerbPsy, Group 2: ExVerb and Group 3: Ex in people with Urinary Incontinence and Frailty, run by Fundación Universidad Católica de Valencia San Vicente Mártir at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, Frailty, Balance Impairment
- What is being tested?
- Group 1: ExVerbPsy, Group 2: ExVerb and Group 3: Ex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 3 Feb 2025to 28 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Escuela de Doctorado. Universidad Católica de Valencia San Vicente Mártir. (Doctoral School. Catholic University of ValenciaSan Vicente Mártir)
Valencia, Valencia, 46001
Pedro Gargallo Bayo, Full professor, pedro.gargallo@uv.es
ESTHER RAMOS CASTELLANO, +34672425826, esther.ramos@ucv.es
About this study
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:
Read more
- A multicomponent exercise group with verbal instructions for pelvic floor exercises.
- A multicomponent exercise group with verbal instructions for pelvic floor exercises and psychoeducation.
- A multicomponent exercise group without verbal instructions for pelvic floor exercises.
- 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.
Read the detailed description
The aging process can lead to the development of major geriatric syndromes, such as falls and urinary incontinence. Although there are studies demonstrating the effectiveness of physical exercise and education in addressing these conditions, there is currently very limited evidence on the combined effects of both therapies on these syndromes.
The primary objective of this study is to evaluate the effects of a multidisciplinary intervention consisting of physiotherapy, physical exercise, and psychoeducation on the risk of falls and urinary incontinence in older adult women.
Methods: This will be a quantitative, quasi-experimental, and longitudinal study with 18 weeks of intervention and a 24-week follow-up period. The study is scheduled to begin in January 2025. The sample will consist of non-institutionalized older adult women aged between 60 and 80 years, who will be randomly assigned to one of four groups:
- A multicomponent exercise group with verbal instructions targeting the pelvic floor.
- A multicomponent exercise group with verbal instructions targeting the pelvic floor and psychoeducation.
- A multicomponent exercise group without verbal instructions targeting the pelvic floor.
- A control group.
Multicomponent exercise sessions will be conducted twice a week and will include exercises focused on balance, strength/power using elastic bands, aerobic capacity, and coordination. The verbal instructions for the pelvic floor will involve performing fast and slow contractions during the general exercises. Participants in the psychoeducation group will attend five group therapy sessions throughout the program.
The study will analyze variables related to balance (Timed Up and Go test, functional reach test, and posturography), lower limb strength/power (isometric strength tests and jump performance), and pelvic floor function (using the PERFECT scale and electromyography). Additionally, physical, psychological, and social well-being variables will be assessed using instruments such as the SF-36, ICIQ-SF, and Rosenberg self-esteem scale.
Results/Conclusion: It is anticipated that differences will emerge between the study groups, with the trimodal intervention group (multicomponent exercise + specific verbal instructions for the pelvic floor + psychoeducation) showing greater improvements in certain parameters.
- Conditions
- Urinary Incontinence, Frailty, Balance Impairment
- Being tested
- Group 1: ExVerbPsy, Group 2: ExVerb, Group 3: Ex
- Keywords
- older women, pelvic floor, balance, multicomponent exercise, urinary incontinence, phsychoeducation
- Medical subject headings
- Urinary Incontinence, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: ExVerbPsyOther
A multidisciplinary intervention will be carried out, consisting of an initial phase of individual physiotherapy based on specific active muscle training of the pelvic floor (EMSP). This will be followed by a group-based multi-component physical exercise program with instructions on pelvic floor contraction during the exercises, and psychoeducation sessions to help cope with the fear of increased likelihood of falls and urinary incontinence as a result of aging.
Group 2: ExVerbOther
The same procedure as experimental group 1 ExVerbPsy will be performed except for the psychoeducation sessions.
Group 3: ExOther
The same procedure as experimental group 1 ExVerbPsy will be performed but without verbal instructions and psychoeducation sessions.
| Study group | Role | What they receive |
|---|---|---|
| Multi-component exercise group with verbal instructions for the pelvic floor and psychoeducation | Experimental | A multidisciplinary intervention will be carried out, consisting of an initial phase of individual physiotherapy based on specific active muscle training of the pelvic floor (EMSP). This will be followed by a group-based multi-component physical exercise program with instructions on pelvic floor contraction during the exercises, and psychoeducation sessions to help cope with the fear of increased likelihood of falls and urinary incontinence as a result of aging. Receives: Other: Group 1: ExVerbPsy |
| Multi-component exercise group with verbal instructions for the pelvic floor | Active comparator | The same procedure as experimental group 1 (exercise + verbal instructions + psychoeducation) will be performed except for the psychoeducation sessions. Receives: Other: Group 2: ExVerb |
| Multicomponent exercise group without verbal instructions for the pelvic floor | Active comparator | The same procedure as experimental group 1 (exercise + verbal instructions + psychoeducation) will be performed but without verbal instructions and psychoeducation sessions. Receives: Other: Group 3: Ex |
| Control group | No intervention | They will receive information sessions on the prevention of geriatric syndromes and will be asked to maintain their normal activity level. At the end of the interventions, this group will have the option of receiving the appropriate intervention that was not carried out in the initial process. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic floor
PERFECT Scale:
Power (P): with Oxford scale 0 to 5 points Endurence (E): 0 to 10 points Repetitions (R): 0 to 10 points Fast (F): 0 to 10 points
Measured: From enrollment to the end of treatment at 18 weeks
Pelvic floor
Intracavitary electromyography: maximum and average contraction. Outcome measure in microvolts.
Measured: From enrollment to the end of treatment at 18 weeks.
Pelvic floor
Manometric perineometer: maximum contraction. Outcome measure in millimeters of mercury.
Measured: From enrollment to the end of treatment at 18 weeks.
Abdominal muscle tone
Abdominal ultrasound of rectus and transverse abdominis: in relaxation and activation with diaphragmatic breathing. Outcome measure in milimeters.
Measured: From enrollment to the end of treatment at 18 weeks.
Dynamic balance
Timed Up and Go: the time it takes for the person to get up from a chair, walk 3 meters, turn on a cone, return to the chair and sit down. Outcome measure in seconds. Less than 10 seconds: low risk of falling. Between 10 and 20 seconds: frailty (medium risk of falling). More than 20 seconds: high risk of falling and disability.
Measured: From enrollment to the end of treatment at 18 weeks
Static balance
Romberg test with feet together, semi-tandem and tandem in 10 seconds. Static one-leg standing balance test with open and closed eyes in 30 seconds. Outcome measure in seconds.
Measured: From enrollment to the end of treatment at 18 weeks.
Static balance
Posturography with and without balance foam: anteroposterior and lateral axis oscillation, and degree of shift of the center of gravity (COP). Outcome measure in milimeters.
Measured: From enrollment to the end of treatment at 18 weeks.
Static balance
Functional reach: distance traveled in anterior displacement with arms outstretched and feet together. Outcome measure in centimeters.
Measured: From enrollment to the end of treatment at 18 weeks.
Gait
Six minutes gait with Runscribe sensors on feet and four meters gait (normal and fast speed)
Measured: From enrollment to the end of treatment at 18 weeks
Power
Jumps (CMJ and ABK), leg extension and squad. Outcome measure in wats.
Measured: From enrollment to the end of treatment at 18 weeks
Power and strenght
Five sit to stand, thirty sit to stand and arm curl. Outcome measure in number of repetitions in 30 seconds.
Measured: From enrollment to the end of treatment at 18 weeks
Strenght and endurance
Isometries of leg extension, hip extension, hip abduction, hip adduction, spine extension and hand grip. Outcome measure in newtons.
Measured: From enrollment to the end of treatment at 18 weeks
Health impact and quality of life
International Consultation on Incontinence Questionnaire (ICIQ-SF): 0 to 21 points from urinary incontinence impact. Outcome measure in units on a scale.
Measured: From enrollment to the end of treatment at 18 weeks.
Psychological and social well-being
Falls efficacy scale: 16 to 64 points from least to most worry about falling. Outcome measure in units on a scale.
Measured: From enrollment to the end of treatment at 18 weeks.
Secondary outcomes (4)
Quality of live
Quality of live with questionnaire Short Form (SF36): this questionnaire evalues in 36 questions the physical function, physical role, body pain, general health, vitality, social function, emotional role, and mental health. 0 to 100 points. Outcome measure in units on a scale.
Measured: From enrollment to the end of treatment at 18 weeks
Psychological and social well-being
Self-esteem questionnaire of Rosenberg: 10 points low self-esteem to 40 points high self-esteem. Outcome measure in units on a scale.
Measured: From enrollment to the end of treatment at 18 weeks.
Weight
Kilograms and information on percentage of lean mass and fat mass.
Measured: From enrollment to the end of treatment at 18 weeks
Height
Stadiometer. Outcome measure in centimeters
Measured: From enrollment to the end of treatment at 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start3 Feb 2025
- Primary completion2 Dec 2025 (estimated)
- Study completion28 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a double blind (investigator-evaluator/data analyst), four arm experimental, parallel and longitudinal study.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Universidad Católica de Valencia San Vicente Mártir
- Sponsor type
- University, hospital or other
- Collaborators
- University of Valencia
- Responsible party
- Principal investigator, Jorge Alarcón Jiménez, Fundación Universidad Católica de Valencia San Vicente Mártir
- Investigators
- ESTHER RAMOS CASTELLANO, Principal investigator, Escuela de Doctorado. Universidad Católica de Valencia San Vicente Mártir (Doctoral School. Catholic University of Valencia San Vicente Mártir)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839040
- Sponsor's protocol ID
- UCV/2022-2023/123
- Acronym
- FIRE-WOMEN
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ramos-Castellano E, Mayordomo-Rodriguez T, Chulvi-Medrano I, Guillamo-Minguez C, Gargallo-Bayo P. Power-Based Multicomponent Training, Pelvic Floor Muscle Activation Instructions, and Psychoeducation for Urinary Incontinence, Balance and Fear of Falling in Older Women (FIRE-WOMEN): Study Protocol for a Randomized Controlled Trial. Healthcare (Basel). 2026 Aug 10;14(16):2467. doi: 10.3390/healthcare14162467.
PubMed 42651237
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Multidisciplinary Intervention on Fall Risk and Urinary Incontinence in Older Women
- ClinicalTrials.gov ID
- NCT06839040
- Acronym / sponsor ID
- FIRE-WOMEN / UCV/2022-2023/123
- Conditions
- Urinary Incontinence, Frailty, Balance Impairment
- Keywords
- older women, pelvic floor, balance, multicomponent exercise, urinary incontinence, phsychoeducation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fundación Universidad Católica de Valencia San Vicente MártirUniversity, hospital or other
- Collaborators
- University of Valencia
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 2 Dec 2025 (estimated)
- Study completion
- 28 Dec 2025 (estimated)
- First posted
- 21 Feb 2025 (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.
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:
- A multicomponent exercise group with verbal instructions for pelvic floor exercises.
- A multicomponent exercise group with verbal instructions for pelvic floor exercises and psychoeducation.
- A multicomponent exercise group without verbal instructions for pelvic floor exercises.
- 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.
Detailed description
The aging process can lead to the development of major geriatric syndromes, such as falls and urinary incontinence. Although there are studies demonstrating the effectiveness of physical exercise and education in addressing these conditions, there is currently very limited evidence on the combined effects of both therapies on these syndromes.
The primary objective of this study is to evaluate the effects of a multidisciplinary intervention consisting of physiotherapy, physical exercise, and psychoeducation on the risk of falls and urinary incontinence in older adult women.
Methods: This will be a quantitative, quasi-experimental, and longitudinal study with 18 weeks of intervention and a 24-week follow-up period. The study is scheduled to begin in January 2025. The sample will consist of non-institutionalized older adult women aged between 60 and 80 years, who will be randomly assigned to one of four groups:
- A multicomponent exercise group with verbal instructions targeting the pelvic floor.
- A multicomponent exercise group with verbal instructions targeting the pelvic floor and psychoeducation.
- A multicomponent exercise group without verbal instructions targeting the pelvic floor.
- A control group.
Multicomponent exercise sessions will be conducted twice a week and will include exercises focused on balance, strength/power using elastic bands, aerobic capacity, and coordination. The verbal instructions for the pelvic floor will involve performing fast and slow contractions during the general exercises. Participants in the psychoeducation group will attend five group therapy sessions throughout the program.
The study will analyze variables related to balance (Timed Up and Go test, functional reach test, and posturography), lower limb strength/power (isometric strength tests and jump performance), and pelvic floor function (using the PERFECT scale and electromyography). Additionally, physical, psychological, and social well-being variables will be assessed using instruments such as the SF-36, ICIQ-SF, and Rosenberg self-esteem scale.
Results/Conclusion: It is anticipated that differences will emerge between the study groups, with the trimodal intervention group (multicomponent exercise + specific verbal instructions for the pelvic floor + psychoeducation) showing greater improvements in certain parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- This will be a double blind (investigator-evaluator/data analyst), four arm experimental, parallel and longitudinal study.
| Arm | Type | Receives |
|---|---|---|
| Multi-component exercise group with verbal instructions for the pelvic floor and psychoeducation | Experimental | Other: Group 1: ExVerbPsyA multidisciplinary intervention will be carried out, consisting of an initial phase of individual physiotherapy based on specific active muscle training of the pelvic floor (EMSP). This will be followed by a group-based multi-component physical exercise program with instructions on pelvic floor contraction during the exercises, and psychoeducation sessions to help cope with the fear of increased likelihood of falls and urinary incontinence as a result of aging. |
| Multi-component exercise group with verbal instructions for the pelvic floor | Active comparator | Other: Group 2: ExVerbThe same procedure as experimental group 1 (exercise + verbal instructions + psychoeducation) will be performed except for the psychoeducation sessions. |
| Multicomponent exercise group without verbal instructions for the pelvic floor | Active comparator | Other: Group 3: ExThe same procedure as experimental group 1 (exercise + verbal instructions + psychoeducation) will be performed but without verbal instructions and psychoeducation sessions. |
| Control group | No intervention | –They will receive information sessions on the prevention of geriatric syndromes and will be asked to maintain their normal activity level. At the end of the interventions, this group will have the option of receiving the appropriate intervention that was not carried out in the initial process. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Group 1: ExVerbPsyA multidisciplinary intervention will be carried out, consisting of an initial phase of individual physiotherapy based on specific active muscle training of the pelvic floor (EMSP). This will be followed by a group-based multi-component physical exercise program with instructions on pelvic floor contraction during the exercises, and psychoeducation sessions to help cope with the fear of increased likelihood of falls and urinary incontinence as a result of aging. | Other | Multi-component exercise group with verbal instructions for the pelvic floor and psychoeducation |
| Group 2: ExVerbThe same procedure as experimental group 1 ExVerbPsy will be performed except for the psychoeducation sessions. | Other | Multi-component exercise group with verbal instructions for the pelvic floor |
| Group 3: ExThe same procedure as experimental group 1 ExVerbPsy will be performed but without verbal instructions and psychoeducation sessions. | Other | Multicomponent exercise group without verbal instructions for the pelvic floor |
Primary outcome
Pelvic floor
Time frame: From enrollment to the end of treatment at 18 weeks
PERFECT Scale: Power (P): with Oxford scale 0 to 5 points Endurence (E): 0 to 10 points Repetitions (R): 0 to 10 points Fast (F): 0 to 10 points
Pelvic floor
Time frame: From enrollment to the end of treatment at 18 weeks.
Intracavitary electromyography: maximum and average contraction. Outcome measure in microvolts.
Pelvic floor
Time frame: From enrollment to the end of treatment at 18 weeks.
Manometric perineometer: maximum contraction. Outcome measure in millimeters of mercury.
Abdominal muscle tone
Time frame: From enrollment to the end of treatment at 18 weeks.
Abdominal ultrasound of rectus and transverse abdominis: in relaxation and activation with diaphragmatic breathing. Outcome measure in milimeters.
Dynamic balance
Time frame: From enrollment to the end of treatment at 18 weeks
Timed Up and Go: the time it takes for the person to get up from a chair, walk 3 meters, turn on a cone, return to the chair and sit down. Outcome measure in seconds. Less than 10 seconds: low risk of falling. Between 10 and 20 seconds: frailty (medium risk of falling). More than 20 seconds: high risk of falling and disability.
Static balance
Time frame: From enrollment to the end of treatment at 18 weeks.
Romberg test with feet together, semi-tandem and tandem in 10 seconds. Static one-leg standing balance test with open and closed eyes in 30 seconds. Outcome measure in seconds.
Static balance
Time frame: From enrollment to the end of treatment at 18 weeks.
Posturography with and without balance foam: anteroposterior and lateral axis oscillation, and degree of shift of the center of gravity (COP). Outcome measure in milimeters.
Static balance
Time frame: From enrollment to the end of treatment at 18 weeks.
Functional reach: distance traveled in anterior displacement with arms outstretched and feet together. Outcome measure in centimeters.
Gait
Time frame: From enrollment to the end of treatment at 18 weeks
Six minutes gait with Runscribe sensors on feet and four meters gait (normal and fast speed)
Power
Time frame: From enrollment to the end of treatment at 18 weeks
Jumps (CMJ and ABK), leg extension and squad. Outcome measure in wats.
Power and strenght
Time frame: From enrollment to the end of treatment at 18 weeks
Five sit to stand, thirty sit to stand and arm curl. Outcome measure in number of repetitions in 30 seconds.
Strenght and endurance
Time frame: From enrollment to the end of treatment at 18 weeks
Isometries of leg extension, hip extension, hip abduction, hip adduction, spine extension and hand grip. Outcome measure in newtons.
Health impact and quality of life
Time frame: From enrollment to the end of treatment at 18 weeks.
International Consultation on Incontinence Questionnaire (ICIQ-SF): 0 to 21 points from urinary incontinence impact. Outcome measure in units on a scale.
Psychological and social well-being
Time frame: From enrollment to the end of treatment at 18 weeks.
Falls efficacy scale: 16 to 64 points from least to most worry about falling. Outcome measure in units on a scale.
4 secondary outcomes
Quality of live
Time frame: From enrollment to the end of treatment at 18 weeks
Psychological and social well-being
Time frame: From enrollment to the end of treatment at 18 weeks.
Weight
Time frame: From enrollment to the end of treatment at 18 weeks
Height
Time frame: From enrollment to the end of treatment at 18 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Derived from this study: PubMed 42651237Ramos-Castellano E, Mayordomo-Rodriguez T, Chulvi-Medrano I, Guillamo-Minguez C, Gargallo-Bayo P. Power-Based Multicomponent Training, Pelvic Floor Muscle Activation Instructions, and Psychoeducation for Urinary Incontinence, Balance and Fear of Falling in Older Women (FIRE-WOMEN): Study Protocol for a Randomized Controlled Trial. Healthcare (Basel). 2026 Aug 10;14(16):2467. doi: 10.3390/healthcare14162467.
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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.
ESTHER RAMOS CASTELLANO principal investigator
Escuela de Doctorado. Universidad Católica de Valencia San Vicente Mártir (Doctoral School. Catholic University of Valencia San Vicente Mártir)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1: ExVerbPsy, Group 2: ExVerb and Group 3: Ex in people with Urinary Incontinence and Frailty, run by Fundación Universidad Católica de Valencia San Vicente Mártir at 1 site in Spain.
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 8 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 21 Feb 2025. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ESTHER RAMOS CASTELLANO (+34672425826, esther.ramos@ucv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic floor (time frame: From enrollment to the end of treatment at 18 weeks). The study lists 14 primary outcomes in all. 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 NCT06839040, which also lists 1 linked publication.
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 21 Feb 2025.