Multiple SclerosisNCT04758468
Effects of Telerehabilitation-Based Pelvic Floor Muscle Training in People With Multiple Sclerosis
A study testing Telerehabilitation-based pelvic floor muscle training and Home-based pelvic floor muscle training in people with Multiple Sclerosis and Urinary Incontinence, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
The effectiveness of pelvic floor muscle training on urinary incontinence and sexual function has been known for many years. However, the evaluation of its effectiveness in people with Multiple Sclerosis (MS) has recently begun and the level of evidence is limited. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Urinary Incontinence
- What is being tested?
- Telerehabilitation-based pelvic floor muscle training and Home-based pelvic floor muscle training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Feb 2021to 15 Nov 2021
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having been diagnosed with MS according to McDonald diagnostic criteria
- Having urinary incontinence
- EDSS score less than 8
- Have the cognitive capacity to complete the assessment and treatment protocol
Who cannot join
- Pregnancy
- Pelvic surgery history
- A history of cesarean or vaginal delivery within 6 months prior to the study
- Progressive disability (1 point increase in EDSS) or attacks in the last 3 months
- Having received pelvic floor muscle training in the last 6 months
- Have had or are receiving treatment for pelvic organ prolapse Patients receiving pharmacological therapy for incontinence whose dose has not changed over the past 3 months will be included, but will be excluded if the dose changes during the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dokuz Eylul University Hospital, MS Outpatient Clinic
Izmir, Inciralti, 35340
About this study
Official title: Effects of Telerehabilitation-Based Pelvic Floor Muscle Training on Urinary Incontinence, Sexual Function and Quality of Life in People With Multiple Sclerosis
The effectiveness of pelvic floor muscle training on urinary incontinence and sexual function has been known for many years. However, the evaluation of its effectiveness in people with Multiple Sclerosis (MS) has recently begun and the level of evidence is limited. In addition, the applicability of pelvic floor muscle training based on telerehabilitation in the presence of a physiotherapist has not been investigated before.
The aims of this study;
Read more
- The main aim of this study is to evaluate the feasibility and acceptability of telerehabilitation-based pelvic floor muscle training under the guidance of a physiotherapist, which will be applied for the first time.
- Another aim is to compare this method with the effects of not receiving treatment other than usual treatment or receiving home-based pelvic floor muscle training on urinary incontinence, sexual dysfunction and psychosocial outcomes.
The participants will randomly be allocated into three groups: (1) Telerehabilitation-based pelvic floor muscle training, (2) Home-based pelvic floor muscle training, and (3) Control group Telerehabilitation-based pelvic floor muscle training group will individually receive telerehabilitation-based pelvic floor muscle training under the guidance of a physiotherapist 2 sessions per week for 8 weeks. Participants will do their exercises themselves 2 times on the days where sessions are held with a physiotherapist. Participants will continue to exercise 3 times a day in the remaining days. The home-based pelvic floor muscle training group will do their individual exercises 3 times a day for 8 weeks. The control group will receive no specific training
Read the detailed description
Both intervention groups will follow the same pelvic floor muscle training protocol for 8 weeks, but the home-based group will follow the exercise protocol individually while the telerehabilitation-based group will follow the telerehabilitation-based under the guidance of the physiotherapist.
Exercises will be applied 3 times a day according to the specified protocol. An information leaflet will be distributed to the home exercise group. The telerehabilitation-based group will receive telerehabilitation-based pelvic floor muscle training under the guidance of a physiotherapist individually for 2 sessions a week, the patient will do the exercises twice a day in the days of the sessions with the physiotherapist, and the remaining days will continue to do it 3 times a day like a home exercise group. The control group will not receive treatment other than their routine treatment, and the patients will be informed that they will be treated if they wish at the end of the study.
The progression in Pelvic Floor Muscle Training will be achieved by increasing the exercise volume and diversifying the positions. The assessments will be applied at baseline, 4, 8, and 12 weeks.
- Conditions
- Multiple Sclerosis, Urinary Incontinence
- Being tested
- Telerehabilitation-based pelvic floor muscle training, Home-based pelvic floor muscle training
- Keywords
- Multiple Sclerosis, Urinary Incontinence, Pelvic Floor Muscle Training, Sexual Function
- Medical subject headings
- Multiple Sclerosis, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation-based pelvic floor muscle trainingBehavioural
Telerehabilitation-based pelvic floor muscle training group will individually receive telerehabilitation-based pelvic floor muscle training under the guidance of a physiotherapist 2 sessions per week for 8 weeks. Participants will do their exercises themselves 2 times on the days where sessions are held with a physiotherapist. Participants will continue to exercise 3 times a day in the remaining days.
Both intervention groups will follow the same pelvic floor muscle training protocol for 8 weeks.
Home-based pelvic floor muscle trainingBehavioural
The home-based pelvic floor muscle training group will do their individual exercises 3 times a day for 8 weeks.
Both intervention groups will follow the same pelvic floor muscle training protocol for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation-based pelvic floor muscle training | Experimental | Not described Receives: Behavioral: Telerehabilitation-based pelvic floor muscle training |
| Home-based pelvic floor muscle training | Active comparator | Not described Receives: Behavioral: Home-based pelvic floor muscle training |
| Control (no specific intervention) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the methods-minimum recruitment rate
A minimum recruitment rate of 10 participants per month will be accepted as feasible.
Measured: Through Study Completion, an Average of 8 Weeks
Feasibility of the methods-minimum retention rate
A target retention rate of 80% will be accepted as feasible.
Measured: Through Study Completion, an Average of 8 Weeks
Feasibility of the methods-minimum adherence rate
A target minimum adherence rate of 70% of the overall practice sessions will be accepted as feasible.
Measured: Through Study Completion, an Average of 8 Weeks
Feasibility of the methods-adverse events
A record sheet was prepared for possible adverse events during the tests and intervention. It includes information about seriousness, expectedness, severity, causality, time, duration of the event and clinical action taken. The numbers of adverse events will be reported.
Measured: Through Study Completion, an Average of 8 Weeks
Change in Leakage Episodes
The bladder diary is a form that is used to objectively evaluate the frequency and severity of urinary incontinence. It will be used to determine the leakage episodes. It will be filled in three days by the patients. The amount of fluid taken in the diary, the amount of urine, the number of incontinence and pad change are recorded.
Measured: The assessments will be applied at baseline, 4, 8, and 12 weeks.
Secondary outcomes (12)
Expanded Disability Status Scale (EDSS)
EDSS is the most frequently used scale in evaluating the disability of individuals with MS. Scoring based on neurological examination findings takes a value between 0-10. While 0 shows normal neurological findings, 10 means death due to MS. In this scale in which pyramidal, cerebral, cerebellar, visual, sensory, brainstem, bladder and bowel functions are scored, the best performance of the patient without any special effort is evaluated.
Measured: The assessment will be applied at baseline.
Change in Patient-Determined Disease Steps Scale (PDDS) Score
PDDS was designed in 1995 as a self-reported outcome measure to enable neurologists without EDSS evaluator certification to measure the level of disability of people with MS. It consists of one question. In PDDS, the patient is asked to choose one of the 9 items that best describes his current walking ability.
Measured: The assessments will be applied at baseline and 8 weeks.
Change in Brief International Cognitive Assessment for MS-Symbol Digit Modalities Test Score
Brief International Cognitive Assessment for MS (BICAMS) has been proposed by an expert panel as a tool for brief cognitive monitoring of individuals with MS in clinical settings.
Processing speed will be assessed with the Symbol Digit Modalities Test, a subsection of BICAMS.
Measured: The assessments will be applied at baseline and 8 weeks.
Change in Brief International Cognitive Assessment for MS-California Verbal Learning Test-Second Edition Score
Brief International Cognitive Assessment for MS (BICAMS) has been proposed by an expert panel as a tool for brief cognitive monitoring of individuals with MS in clinical settings.
Verbal learning and memory will be assessed with the California Verbal Learning Test-Second Edition, a subsection of BICAMS.
Measured: The assessments will be applied at baseline and 8 weeks.
Change in Brief International Cognitive Assessment for MS-Brief Visuospatial Memory Test-Revised Score
Brief International Cognitive Assessment for MS (BICAMS) has been proposed by an expert panel as a tool for brief cognitive monitoring of individuals with MS in clinical settings.
Visual-spatial learning and memory will be assessed with the Brief Visuospatial Memory Test-Revised, a subsection of BICAMS.
Measured: The assessments will be applied at baseline and 8 weeks.
Change in Pad Usage
The bladder diary is a form that is used to objectively evaluate the frequency and severity of urinary incontinence. It will be used to determine the pad usage. It will be filled in three days by the patients. The amount of fluid taken in the diary, the amount of urine, the number of incontinence and pad change are recorded.
Measured: The assessments will be applied at baseline, 4, 8, and 12 weeks.
Change in International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form Score
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form was developed to evaluate the effect of urinary incontinence and urinary incontinence on quality of life. The scale has four dimensions. The first dimension questions the frequency of urinary incontinence, the second dimension questions the amount of incontinence, the third dimension questions the effect of urinary incontinence on daily life, and the fourth dimension questions the conditions that cause urinary incontinence. In the evaluation, the first three dimensions are scored. Responses to the fourth dimension are used to determine the type of urinary incontinence based on the individual's complaints. The scores that can be obtained from the scale range from 0-21; a low score indicates that urinary incontinence affects the quality of lifeless, while a high score indicates that it affects a lot.
Measured: The assessments will be applied at baseline, 4, 8, and 12 weeks.
Change in Overactive Bladder-Validated 8-Question (OAB-V8) Score
The OAB-V8 is a screening and awareness test that is used to evaluate the symptoms of urgency, urination, frequent urination and feeling of urine at night and waking up in the overactive bladder. The scale consists of 8 items and answers are scored on a 6-level Likert scale. A maximum score of 40 can be obtained from the scale, and a score below 8 eliminates overactive bladder.
Measured: The assessments will be applied at baseline, 4, 8, and 12 weeks.
Change in EuroQOL 5-Dimension 3-Level Questionnaire Score
EuroQOL 5-Dimension 3-Level is a self-report scale developed to evaluate the quality of life and consists of two parts. The first part contains five dimensions. These dimensions are mobility, self-care, usual daily activities, pain/discomfort, and anxiety/depression. These five dimensions are evaluated with one question each. Answers to each dimension; It is scored between 1 and 3. The second part includes a visual analog scale in which the respondents evaluate their current health status between 0 and 100.
Measured: The assessments will be applied at baseline, 4, 8, and 12 weeks.
Change in Multiple Sclerosis Intimacy and Sexuality Questionnaire-19 (MSISQ-19) Score
MSISQ-19 is a test that standardizes primary (direct result of demyelinating lesions), secondary (consequence of other symptoms) and tertiary (related to psychological, emotional, social and cultural factors) sexual dysfunction in the MS population in the last 6 months. It consists of 19 questions and is based on self-assessment in sexual activity and satisfaction. It is scored between 1 and 5.
Measured: The assessments will be applied at baseline, 4, 8, and 12 weeks.
Change in Hospital Anxiety and Depression Scale (HADS) Score
HADS is used to determine the risk of anxiety and depression in the patient and to measure its level and severity. It is a self-report scale consisting of 7 anxiety and 7 depression related questions in total and two subscales. Items are scored with a 3-level Likert-type scale. Higher scores indicate more symptoms.
Measured: The assessments will be applied at baseline, 4, 8, and 12 weeks.
Change in the number of falls due to a sense of urgency
The number of falls will be questioned because of the sensing of impingement in the last three months.
Measured: The assessments will be applied at baseline and 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start18 Feb 2021
- Primary completion15 Nov 2021
- Study completion15 Nov 2021
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 Multiple SclerosisStudies 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Collaborators
- Izmir Katip Celebi University
- Responsible party
- Principal investigator, Turhan Kahraman, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758468
- Sponsor's protocol ID
- 5742-GOA
- Status last verified
- Mar 2022
- First submitted
- 11 Feb 2021
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yavas I, Kahraman T, Sagici O, Ozdogar AT, Yigit P, Baba C, Ozakbas S. Feasibility of Telerehabilitation-Based Pelvic Floor Muscle Training for Urinary Incontinence in People With Multiple Sclerosis: A Randomized, Controlled, Assessor-Blinded Study. J Neurol Phys Ther. 2023 Oct 1;47(4):217-226. doi: 10.1097/NPT.0000000000000448. Epub 2023 Jun 12.
PubMed 37306430
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Telerehabilitation-Based Pelvic Floor Muscle Training on Urinary Incontinence, Sexual Function and Quality of Life in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04758468
- Acronym / sponsor ID
- 5742-GOA
- Conditions
- Multiple Sclerosis, Urinary Incontinence
- Keywords
- Multiple Sclerosis, Urinary Incontinence, Pelvic Floor Muscle Training, Sexual Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Collaborators
- Izmir Katip Celebi University
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 17 Feb 2021 (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.
The effectiveness of pelvic floor muscle training on urinary incontinence and sexual function has been known for many years. However, the evaluation of its effectiveness in people with Multiple Sclerosis (MS) has recently begun and the level of evidence is limited. In addition, the applicability of pelvic floor muscle training based on telerehabilitation in the presence of a physiotherapist has not been investigated before.
The aims of this study;
- The main aim of this study is to evaluate the feasibility and acceptability of telerehabilitation-based pelvic floor muscle training under the guidance of a physiotherapist, which will be applied for the first time.
- Another aim is to compare this method with the effects of not receiving treatment other than usual treatment or receiving home-based pelvic floor muscle training on urinary incontinence, sexual dysfunction and psychosocial outcomes.
The participants will randomly be allocated into three groups: (1) Telerehabilitation-based pelvic floor muscle training, (2) Home-based pelvic floor muscle training, and (3) Control group Telerehabilitation-based pelvic floor muscle training group will individually receive telerehabilitation-based pelvic floor muscle training under the guidance of a physiotherapist 2 sessions per week for 8 weeks. Participants will do their exercises themselves 2 times on the days where sessions are held with a physiotherapist. Participants will continue to exercise 3 times a day in the remaining days. The home-based pelvic floor muscle training group will do their individual exercises 3 times a day for 8 weeks. The control group will receive no specific training
Detailed description
Both intervention groups will follow the same pelvic floor muscle training protocol for 8 weeks, but the home-based group will follow the exercise protocol individually while the telerehabilitation-based group will follow the telerehabilitation-based under the guidance of the physiotherapist.
Exercises will be applied 3 times a day according to the specified protocol. An information leaflet will be distributed to the home exercise group. The telerehabilitation-based group will receive telerehabilitation-based pelvic floor muscle training under the guidance of a physiotherapist individually for 2 sessions a week, the patient will do the exercises twice a day in the days of the sessions with the physiotherapist, and the remaining days will continue to do it 3 times a day like a home exercise group. The control group will not receive treatment other than their routine treatment, and the patients will be informed that they will be treated if they wish at the end of the study.
The progression in Pelvic Floor Muscle Training will be achieved by increasing the exercise volume and diversifying the positions. The assessments will be applied at baseline, 4, 8, and 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation-based pelvic floor muscle training | Experimental | Behavioral: Telerehabilitation-based pelvic floor muscle training |
| Home-based pelvic floor muscle training | Active comparator | Behavioral: Home-based pelvic floor muscle training |
| Control (no specific intervention) | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having been diagnosed with MS according to McDonald diagnostic criteria
- Having urinary incontinence
- EDSS score less than 8
- Have the cognitive capacity to complete the assessment and treatment protocol
Key exclusion criteria (6 listed)
- Pregnancy
- Pelvic surgery history
- A history of cesarean or vaginal delivery within 6 months prior to the study
- Progressive disability (1 point increase in EDSS) or attacks in the last 3 months
- Having received pelvic floor muscle training in the last 6 months
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 |
|---|---|---|
| Telerehabilitation-based pelvic floor muscle trainingTelerehabilitation-based pelvic floor muscle training group will individually receive telerehabilitation-based pelvic floor muscle training under the guidance of a physiotherapist 2 sessions per week for 8 weeks. Participants will do their exercises themselves 2 times on the days where sessions are held with a physiotherapist. Participants will continue to exercise 3 times a day in the remaining days. Both intervention groups will follow the same pelvic floor muscle training protocol for 8 weeks. | Behavioural | Telerehabilitation-based pelvic floor muscle training |
| Home-based pelvic floor muscle trainingThe home-based pelvic floor muscle training group will do their individual exercises 3 times a day for 8 weeks. Both intervention groups will follow the same pelvic floor muscle training protocol for 8 weeks. | Behavioural | Home-based pelvic floor muscle training |
Primary outcome
Feasibility of the methods-minimum recruitment rate
Time frame: Through Study Completion, an Average of 8 Weeks
A minimum recruitment rate of 10 participants per month will be accepted as feasible.
Feasibility of the methods-minimum retention rate
Time frame: Through Study Completion, an Average of 8 Weeks
A target retention rate of 80% will be accepted as feasible.
Feasibility of the methods-minimum adherence rate
Time frame: Through Study Completion, an Average of 8 Weeks
A target minimum adherence rate of 70% of the overall practice sessions will be accepted as feasible.
Feasibility of the methods-adverse events
Time frame: Through Study Completion, an Average of 8 Weeks
A record sheet was prepared for possible adverse events during the tests and intervention. It includes information about seriousness, expectedness, severity, causality, time, duration of the event and clinical action taken. The numbers of adverse events will be reported.
Change in Leakage Episodes
Time frame: The assessments will be applied at baseline, 4, 8, and 12 weeks.
The bladder diary is a form that is used to objectively evaluate the frequency and severity of urinary incontinence. It will be used to determine the leakage episodes. It will be filled in three days by the patients. The amount of fluid taken in the diary, the amount of urine, the number of incontinence and pad change are recorded.
12 secondary outcomes
Expanded Disability Status Scale (EDSS)
Time frame: The assessment will be applied at baseline.
Change in Patient-Determined Disease Steps Scale (PDDS) Score
Time frame: The assessments will be applied at baseline and 8 weeks.
Change in Brief International Cognitive Assessment for MS-Symbol Digit Modalities Test Score
Time frame: The assessments will be applied at baseline and 8 weeks.
Change in Brief International Cognitive Assessment for MS-California Verbal Learning Test-Second Edition Score
Time frame: The assessments will be applied at baseline and 8 weeks.
Change in Brief International Cognitive Assessment for MS-Brief Visuospatial Memory Test-Revised Score
Time frame: The assessments will be applied at baseline and 8 weeks.
Change in Pad Usage
Time frame: The assessments will be applied at baseline, 4, 8, and 12 weeks.
Change in International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form Score
Time frame: The assessments will be applied at baseline, 4, 8, and 12 weeks.
Change in Overactive Bladder-Validated 8-Question (OAB-V8) Score
Time frame: The assessments will be applied at baseline, 4, 8, and 12 weeks.
Change in EuroQOL 5-Dimension 3-Level Questionnaire Score
Time frame: The assessments will be applied at baseline, 4, 8, and 12 weeks.
Change in Multiple Sclerosis Intimacy and Sexuality Questionnaire-19 (MSISQ-19) Score
Time frame: The assessments will be applied at baseline, 4, 8, and 12 weeks.
Change in Hospital Anxiety and Depression Scale (HADS) Score
Time frame: The assessments will be applied at baseline, 4, 8, and 12 weeks.
Change in the number of falls due to a sense of urgency
Time frame: The assessments will be applied at baseline and 8 weeks.
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 29 Mar 2022.
- Derived from this study: PubMed 37306430Yavas I, Kahraman T, Sagici O, Ozdogar AT, Yigit P, Baba C, Ozakbas S. Feasibility of Telerehabilitation-Based Pelvic Floor Muscle Training for Urinary Incontinence in People With Multiple Sclerosis: A Randomized, Controlled, Assessor-Blinded Study. J Neurol Phys Ther. 2023 Oct 1;47(4):217-226. doi: 10.1097/NPT.0000000000000448. Epub 2023 Jun 12.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation-based pelvic floor muscle training and Home-based pelvic floor muscle training in people with Multiple Sclerosis and Urinary Incontinence, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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 29 Mar 2022. 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 Turkey (Türkiye). 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?
Feasibility of the methods-minimum recruitment rate (time frame: Through Study Completion, an Average of 8 Weeks). The study lists 5 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 NCT04758468, 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 29 Mar 2022.