Urinary IncontinenceNCT05970796
A Telehealth-delivered Physical Therapy Program for Postmenopausal Women with Urinary Incontinence
A study testing Pelvic floor muscle training in people with Urinary Incontinence, run by National Taiwan University at 1 site in Taiwan.
Trial summary
Postmenopausal women frequently report physical (hot flushes, night sweat, insomnia, vaginal dryness, sexual dysfunction, urinary incontinence, reduced fitness level, osteoporotic symptoms, sarcopenia, decreased fat free mass, etc.) and psychological (depression, anxiety, cognitive decline, etc.) symptoms. Read more about this study
- Who is it for?
- Ages 40 to 85 years, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Pelvic floor muscle training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2023to 31 Oct 2024
- Phase
- Interventional
- 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 40 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women aged over 40 years
- postmenopausal women: amenorrhea for longer than 12 months
- having symptomatic UI (defined as having the Questionnaire for Urinary Incontinence Diagnosis score > 0 point)
- being able to answer the questionnaire correctly (no language barrier or cognitive problems)
- having no other physical or psychological problem that would interfere participation in the study
- having access to a mobile video conference device with internet access
Who cannot join
- women aged over 85 years old
- receiving hormone therapy
- having neurological conditions, malignancy for pelvic organ, overflow incontinence or voiding dysfunction
- had received radical surgery for pelvis, sling or prolapse surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Feasibility and Effects of a Telehealth-delivered Physical Therapy Program for Postmenopausal Women with Urinary Incontinence
Postmenopausal women frequently report physical (hot flushes, night sweat, insomnia, vaginal dryness, sexual dysfunction, urinary incontinence, reduced fitness level, osteoporotic symptoms, sarcopenia, decreased fat free mass, etc.) and psychological (depression, anxiety, cognitive decline, etc.) symptoms. Among these symptoms, urinary incontinence is one of the most common manifestations of pelvic floor dysfunction and may significantly impact on women's quality of life. Urinary incontinence is highly prevalent (30%) in postmenopausal women and is primarily attributed to the decreased level of estrogen. Other potential risk factors for urinary incontinence after menopause include age, parity, genetic factors, pregnancy, overweight/obesity, low physical activity levels, diabetes, urinary tract infection, etc. International guidelines recommend lifestyle and behavioral change, pelvic floor muscle training and bladder training as first-line treatments for urinary incontinence in postmenopausal women. During the COVID-19 pandemic, access to and utilization of healthcare services is reduced. As travel distance has been reported as one of the strong barriers to healthcare among patients with incontinence, research has been conducted to investigate the applications and effects of telehealth. While telehealth rehabilitation may improve urinary incontinence symptoms, the field is still emerging and more studies are needed to elucidate how physical therapists can perform telehealth pelvic floor muscle training for urinary incontinence.
The objectives of this three-year study are:
- to investigate the feasibility of a telehealth-delivered physical therapy program for postmenopausal women with urinary incontinence
- to explore the effects of a telehealth-delivered physical therapy program on urinary incontinence symptoms, pelvic floor muscle function and quality of life in postmenopausal women with urinary incontinence
- to compare the effectiveness of telehealth physical therapy program with face-to-face physical therapy in this population
- to compare body composition, physical activity levels, functional capacity, grip strength, urinary incontinence symptoms, and pelvic floor muscles function in women at early versus late stage of post-menopause
- to evaluate the relationships between duration after menopause and body composition, physical activity levels, functional capacity, grip strength, urinary incontinence symptoms, and pelvic floor muscles function
Read the detailed description
This is a non-inferiority randomized controlled trial with a nested cross-sectional study and a nested qualitative interview study. Sixty community-dwelling postmenopausal women with urinary incontinence, aged >40 years, will be recruited and randomly allocated to two groups, telehealth group or face-to-face group. All groups will receive a 12-week pelvic floor muscle training. The face-to-face group will be supervised by a female physical therapist who will provide pelvic floor muscle training twice a week. The training will be adjusted according to the performance of the participant. The telehealth group will receive eight sessions of individualized pelvic floor muscle training provided by a physical therapist via telehealth in addition to a weekly telephone coaching. The baseline, post-intervention, and 3-month follow-up assessments will include feasibility outcomes, measurements of anthropometry, body composition (body composition monitor), hand grip strength (dynamometer), functional exercise capacity (six minute walk test), and pelvic floor muscle function (vaginal manometry, transperineal ultrasound and digital palpation) and two questionnaires about symptom severity of urinary incontinence and physical activity levels. This study will provide evidence of effectiveness of different delivery modes of physical therapy program for postmenopausal women with urinary incontinence and health-care professionals working with this population in clinical practice.
- Conditions
- Urinary Incontinence
- Being tested
- Pelvic floor muscle training
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor muscle trainingBehavioural
The pelvic floor muscle training program will be provided via an intra-vaginal biofeedback device - Smart Kegel Trainer, which will be connected to the product application installed on the mobile phone or tablet so the participants can monitor their pelvic floor contractions in real time and directly in the application. Participants will be asked to complete three sets of 8 to 12 maximal pelvic floor muscle contractions and three to ten fast contractions per training session. The home program will be tailored to each participant and include "pelvic floor safe" exercises recommended by the Continence Foundation of Australia.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth group | Experimental | The telehealth group will receive eight sessions of individualized pelvic floor muscle training provided by a physical therapist via telehealth in 12 weeks. Receives: Behavioral: Pelvic floor muscle training |
| Face-to-face group | Active comparator | The face-to-face group will be supervised by a female physical therapist who will provide pelvic floor muscle training twice a week for 12 weeks. Receives: Behavioral: Pelvic floor muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants consented to participate
Consent rate: number of participants enrolled will be divided by number of eligible patients approached
Measured: absolute values at baseline
Number of intervention sessions attended
Attendance rate: number of sessions attended will be divided by the total number of expected sessions within each treatment arm
Measured: absolute values at 12 weeks
Number of participants who remain in the study 3 months after baseline assessment
Retention rate: number of participants who remain in the study at 3-month follow-up as a proportion of the total number of participants recruited at the baseline assessment
Measured: absolute values at 3 months
Number of participants who withdrew from the trial
Withdrawal rate: number of participants who withdraw from the trial after consenting divided by the number of participants who initially consent to the trial
Measured: absolute values at 12 weeks and 3 months
Number of completed training sessions in relation to the scheduled sessions
Adherence rate: the total number of exercise sessions completed as a proportion of that prescribed each week from baseline to 12 week.
Measured: absolute values at 12 weeks
Number of participants with intervention-related adverse events as assessed by CTCAE v4.0
Adverse events: the number of adverse or serious adverse events throughout the 12-week intervention period. Participants will be asked about any symptoms (such as pain, bleeding or itching) at each training session.
Measured: absolute values at 12 weeks
Satisfaction scale
Satisfaction will be was assessed using a five-point Likert-scale ranging from '1 = very dissatisfied' to '5 = very satisfied'.
Measured: absolute values at 12 weeks
Acceptability scale
Acceptability will be was assessed using a five-point Likert-scale ranging from '1 = very dissatisfied' to '5 = very satisfied'.
Measured: absolute values at 12 weeks
Secondary outcomes (14)
Weight
Weight in kilograms will be measured using a Full Body Sensor Body Composition Monitor.
Measured: absolute values at 12 weeks and 3 months
Height
Height in meters will be measured using a measuring tape.
Measured: absolute values at 12 weeks and 3 months
Body mass index
Weight and height will be combined to report body mass index in kg/m^2
Measured: absolute values at 12 weeks and 3 months
Body fat percentage
Body fat percentage will be measured using a Full Body Sensor Body Composition Monitor. Body fat percentage will be classified as 5.0 to 19.9% (low), 20.0 to 29.9% (normal), 30.0 to 34.9% (high), and 35.0% and above (very high).
Measured: absolute values at 12 weeks and 3 months
Visceral fat level
Visceral fat level will be measured using a Full Body Sensor Body Composition Monitor. Visceral fat level will be classified as 1 to 9 (normal), 10 to 14 (high), and 15 to 30 (very high).
Measured: absolute values at 12 weeks and 3 months
Skeletal muscle percentage
Skeletal muscle percentage will be measured using a Full Body Sensor Body Composition Monitor. Skeletal muscle percentage will be classified as 5.0 to 25.8% (low), 25.9 to 37.9% (normal), 28.0 to 29.0% (high), and 29.1 to 60.0% (very high).
Measured: absolute values at 12 weeks and 3 months
Handgrip strength
The grip strength of dominant hand will be measured in kilograms using a Jamar Plus+ Dynamometer.
Measured: absolute values at 12 weeks and 3 months
Functional exercise capacity
Functional exercise capacity will be assessed using six-minute walk test. The distance covered over a time of 6 minutes will be recorded in meters.
Measured: absolute values at 12 weeks and 3 months
Pelvic floor muscle strength
Pelvic floor muscle strength will be measured using digital palpation. The results will be recorded using the modified Oxford Grading scale, which quantifies pelvic floor muscle strength as: 0, no contraction; 1, flicker; 2, weak; 3, moderate; 4, good; and 5, strong.
Measured: absolute values at 12 weeks and 3 months
Bladder neck descent
Bladder neck descent will be measured in centimeters using a transperineal ultrasound at rest and during maximal voluntary contraction.
Measured: absolute values at 12 weeks and 3 months
Anteroposterior diameter of the urogenital levator hiatus
Anteroposterior diameter of the urogenital levator hiatus will be measured in centimeters using a transperineal ultrasound at rest and during maximal voluntary contraction.
Measured: absolute values at 12 weeks and 3 months
Anorectal angle
Anorectal angle will be measured using a transperineal ultrasound. The anorectal angle between the anal canal longitudinal axis and the posterior rectal line will be measured in degrees at rest and during maximal voluntary contraction.
Measured: absolute values at 12 weeks and 3 months
Severity of urinary incontinence
The severity of urinary incontinence will be measured using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form. The total score ranges from 0-21 with a higher score indicating greater severity of symptoms.
Measured: absolute values at 12 weeks and 3 months
Physical activity levels
The International Physical Activity Questionnaire - Short Form will be used to measure total physical activity levels in MET minutes a week with a higher score corresponding to a higher physical activity level.
Measured: absolute values at 12 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Dec 2023
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuan-Yin Lin, National Taiwan University
- Investigators
- Kuan-Yin Lin, Ph.D., Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970796
- Sponsor's protocol ID
- NSTC 112-2314-B-002-315-
- Status last verified
- Nov 2024
- First submitted
- 21 Jul 2023
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lin KY, Chen CY, Wu PC, Huang MH, Ou YC, Kao YL, Lin KH. The feasibility and effects of a telehealth-delivered physical therapy program for postmenopausal women with urinary incontinence: A pilot mixed-methods study. Maturitas. 2025 Jun;197:108376. doi: 10.1016/j.maturitas.2025.108376. Epub 2025 Apr 23.
PubMed 40286562Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.
PubMed 39704322
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Effects of a Telehealth-delivered Physical Therapy Program for Postmenopausal Women with Urinary Incontinence
- ClinicalTrials.gov ID
- NCT05970796
- Acronym / sponsor ID
- NSTC 112-2314-B-002-315-
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- National Taiwan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 1 Aug 2023 (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.
Postmenopausal women frequently report physical (hot flushes, night sweat, insomnia, vaginal dryness, sexual dysfunction, urinary incontinence, reduced fitness level, osteoporotic symptoms, sarcopenia, decreased fat free mass, etc.) and psychological (depression, anxiety, cognitive decline, etc.) symptoms. Among these symptoms, urinary incontinence is one of the most common manifestations of pelvic floor dysfunction and may significantly impact on women's quality of life. Urinary incontinence is highly prevalent (30%) in postmenopausal women and is primarily attributed to the decreased level of estrogen. Other potential risk factors for urinary incontinence after menopause include age, parity, genetic factors, pregnancy, overweight/obesity, low physical activity levels, diabetes, urinary tract infection, etc. International guidelines recommend lifestyle and behavioral change, pelvic floor muscle training and bladder training as first-line treatments for urinary incontinence in postmenopausal women. During the COVID-19 pandemic, access to and utilization of healthcare services is reduced. As travel distance has been reported as one of the strong barriers to healthcare among patients with incontinence, research has been conducted to investigate the applications and effects of telehealth. While telehealth rehabilitation may improve urinary incontinence symptoms, the field is still emerging and more studies are needed to elucidate how physical therapists can perform telehealth pelvic floor muscle training for urinary incontinence.
The objectives of this three-year study are:
- to investigate the feasibility of a telehealth-delivered physical therapy program for postmenopausal women with urinary incontinence
- to explore the effects of a telehealth-delivered physical therapy program on urinary incontinence symptoms, pelvic floor muscle function and quality of life in postmenopausal women with urinary incontinence
- to compare the effectiveness of telehealth physical therapy program with face-to-face physical therapy in this population
- to compare body composition, physical activity levels, functional capacity, grip strength, urinary incontinence symptoms, and pelvic floor muscles function in women at early versus late stage of post-menopause
- to evaluate the relationships between duration after menopause and body composition, physical activity levels, functional capacity, grip strength, urinary incontinence symptoms, and pelvic floor muscles function
Detailed description
This is a non-inferiority randomized controlled trial with a nested cross-sectional study and a nested qualitative interview study. Sixty community-dwelling postmenopausal women with urinary incontinence, aged >40 years, will be recruited and randomly allocated to two groups, telehealth group or face-to-face group. All groups will receive a 12-week pelvic floor muscle training. The face-to-face group will be supervised by a female physical therapist who will provide pelvic floor muscle training twice a week. The training will be adjusted according to the performance of the participant. The telehealth group will receive eight sessions of individualized pelvic floor muscle training provided by a physical therapist via telehealth in addition to a weekly telephone coaching. The baseline, post-intervention, and 3-month follow-up assessments will include feasibility outcomes, measurements of anthropometry, body composition (body composition monitor), hand grip strength (dynamometer), functional exercise capacity (six minute walk test), and pelvic floor muscle function (vaginal manometry, transperineal ultrasound and digital palpation) and two questionnaires about symptom severity of urinary incontinence and physical activity levels. This study will provide evidence of effectiveness of different delivery modes of physical therapy program for postmenopausal women with urinary incontinence and health-care professionals working with this population in clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telehealth group | Experimental | Behavioral: Pelvic floor muscle trainingThe telehealth group will receive eight sessions of individualized pelvic floor muscle training provided by a physical therapist via telehealth in 12 weeks. |
| Face-to-face group | Active comparator | Behavioral: Pelvic floor muscle trainingThe face-to-face group will be supervised by a female physical therapist who will provide pelvic floor muscle training twice a week for 12 weeks. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- women aged over 40 years
- postmenopausal women: amenorrhea for longer than 12 months
- having symptomatic UI (defined as having the Questionnaire for Urinary Incontinence Diagnosis score > 0 point)
- being able to answer the questionnaire correctly (no language barrier or cognitive problems)
- having no other physical or psychological problem that would interfere participation in the study
Key exclusion criteria (4 listed)
- women aged over 85 years old
- receiving hormone therapy
- having neurological conditions, malignancy for pelvic organ, overflow incontinence or voiding dysfunction
- had received radical surgery for pelvis, sling or prolapse surgery
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 |
|---|---|---|
| Pelvic floor muscle trainingThe pelvic floor muscle training program will be provided via an intra-vaginal biofeedback device - Smart Kegel Trainer, which will be connected to the product application installed on the mobile phone or tablet so the participants can monitor their pelvic floor contractions in real time and directly in the application. Participants will be asked to complete three sets of 8 to 12 maximal pelvic floor muscle contractions and three to ten fast contractions per training session. The home program will be tailored to each participant and include "pelvic floor safe" exercises recommended by the Continence Foundation of Australia. | Behavioural | Face-to-face group, Telehealth group |
Primary outcome
Number of participants consented to participate
Time frame: absolute values at baseline
Consent rate: number of participants enrolled will be divided by number of eligible patients approached
Number of intervention sessions attended
Time frame: absolute values at 12 weeks
Attendance rate: number of sessions attended will be divided by the total number of expected sessions within each treatment arm
Number of participants who remain in the study 3 months after baseline assessment
Time frame: absolute values at 3 months
Retention rate: number of participants who remain in the study at 3-month follow-up as a proportion of the total number of participants recruited at the baseline assessment
Number of participants who withdrew from the trial
Time frame: absolute values at 12 weeks and 3 months
Withdrawal rate: number of participants who withdraw from the trial after consenting divided by the number of participants who initially consent to the trial
Number of completed training sessions in relation to the scheduled sessions
Time frame: absolute values at 12 weeks
Adherence rate: the total number of exercise sessions completed as a proportion of that prescribed each week from baseline to 12 week.
Number of participants with intervention-related adverse events as assessed by CTCAE v4.0
Time frame: absolute values at 12 weeks
Adverse events: the number of adverse or serious adverse events throughout the 12-week intervention period. Participants will be asked about any symptoms (such as pain, bleeding or itching) at each training session.
Satisfaction scale
Time frame: absolute values at 12 weeks
Satisfaction will be was assessed using a five-point Likert-scale ranging from '1 = very dissatisfied' to '5 = very satisfied'.
Acceptability scale
Time frame: absolute values at 12 weeks
Acceptability will be was assessed using a five-point Likert-scale ranging from '1 = very dissatisfied' to '5 = very satisfied'.
14 secondary outcomes
Weight
Time frame: absolute values at 12 weeks and 3 months
Height
Time frame: absolute values at 12 weeks and 3 months
Body mass index
Time frame: absolute values at 12 weeks and 3 months
Body fat percentage
Time frame: absolute values at 12 weeks and 3 months
Visceral fat level
Time frame: absolute values at 12 weeks and 3 months
Skeletal muscle percentage
Time frame: absolute values at 12 weeks and 3 months
Handgrip strength
Time frame: absolute values at 12 weeks and 3 months
Functional exercise capacity
Time frame: absolute values at 12 weeks and 3 months
Pelvic floor muscle strength
Time frame: absolute values at 12 weeks and 3 months
Bladder neck descent
Time frame: absolute values at 12 weeks and 3 months
Anteroposterior diameter of the urogenital levator hiatus
Time frame: absolute values at 12 weeks and 3 months
Anorectal angle
Time frame: absolute values at 12 weeks and 3 months
Severity of urinary incontinence
Time frame: absolute values at 12 weeks and 3 months
Physical activity levels
Time frame: absolute values at 12 weeks and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Derived from this study: PubMed 40286562Lin KY, Chen CY, Wu PC, Huang MH, Ou YC, Kao YL, Lin KH. The feasibility and effects of a telehealth-delivered physical therapy program for postmenopausal women with urinary incontinence: A pilot mixed-methods study. Maturitas. 2025 Jun;197:108376. doi: 10.1016/j.maturitas.2025.108376. Epub 2025 Apr 23.
- Derived from this study: PubMed 39704322Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.
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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.
Kuan-Yin Lin, Ph.D. principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor muscle training in people with Urinary Incontinence, run by National Taiwan University at 1 site in Taiwan.
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 6 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: finished, as of the sponsor's last update on 14 Nov 2024. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants consented to participate (time frame: absolute values at baseline). The study lists 8 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 NCT05970796, which also lists 2 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 14 Nov 2024.