Lower Urinary Tract SymptomsNCT04759391
Effects of Digital Pelvic Floor Muscle Training in Patients With Multiple Sclerosis Having Lower Urinary Tract Symptoms
A study testing Exercise and Lifestyle recommendations in people with Lower Urinary Tract Symptoms, run by Ataturk Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effects of digital pelvic floor muscle training and lifestyle recommendations in patients with Multiple Sclerosis having lower urinary tract symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lower Urinary Tract Symptoms
- What is being tested?
- Exercise and Lifestyle recommendations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2021to Jul 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 a diagnosis of MS and having at least two of the lower urinary symptoms
- Not having an attack in the last 1 month,
- No change in medical treatment in the last 3 months
- "Expanded disability status scale-EDSS" score is less than 6.5
- Not having any cognitive problems that would hinder cooperation and understanding
- Those who use digital devices such as computers, laptops, smartphones and tablets
- Volunteering to participate in the study
Who cannot join
- Pregnancy status
- Active urinary tract infection
- Another neurological disease that can cause incontinence
- A history of malignancy
- Prostate surgery
- Those with missing evaluation parameters
- Those who do not regularly participate in treatment programs
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yildirim Beyazit University
Ankara
Seyda Toprak Celenay
About this study
Official title: Effects of Digital Pelvic Floor Muscle Training and Lifestyle Recommendations in Patients With Multiple Sclerosis Having Lower Urinary Tract Symptoms
The aim of this study was to investigate the effects of digital pelvic floor muscle training and lifestyle recommendations in patients with Multiple Sclerosis having lower urinary tract symptoms.
Read the detailed description
Multiple sclerosis (MS) is an autoimmune, neurodegenerative disease of the central nervous system. Lower urinary tract symptoms (LUTS) are very common in MS. Pelvic floor muscle training (PFMT) is one of the first-line choices for the conservative treatment of LUTS.
According to our knowledge, no study has investigated the effects of digital pelvic floor muscle training and lifestyle recommendations in MS having LUTS, yet.
- Conditions
- Lower Urinary Tract Symptoms
- Being tested
- Exercise, Lifestyle recommendations
- Keywords
- Lower Urinary Tract Symptoms, Multiple Sclerosis, Pelvic Floor Muscle Training
- Medical subject headings
- Lower Urinary Tract Symptoms, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Pelvic floor muscle training program planned under the supervision of a physiotherapist was applied and followed to the exercise group, using the digital application.
Lifestyle recommendationsOther
Information was given within the scope of lifestyle recommendations (fluid intake, diet, constipation, weight control, smoking related to lower urinary system symptoms
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Lifestyle recommendations as well as digital pelvic floor muscle training to the exercise group Receives: Other: Exercise; Other: Lifestyle recommendations |
| Control group | Active comparator | Lifestyle recommendations will be given to the control group Receives: Other: Lifestyle recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incontinence symtoms
Urinary incontinence symptoms will be evaluated with The International Consultation of Incontinence Questionnaire - Short Form
Measured: change from baseline at 8 weeks
Overactive bladder symptoms
Overactive bladder symptoms will be evaluated with Overactive Bladder Questionnaire-Version8
Measured: change from baseline at 8 weeks
Secondary outcomes (4)
bladder functions
bladder functions will be evaluated with voiding diary
Measured: change from baseline at 8 weeks
Quality of life level
Quality of life will be evaluated with King's Health Questionnaire
Measured: change from baseline at 8 weeks
subjective perception of improvement
subjective perception of improvement will be evaluated with a 4-item Likert-type scale
Measured: after treatment (8th week)
patient satisfaction
patient satisfaction will be evaluated with a 5-item Likert-type scale
Measured: after treatment (8th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study startFeb 2021 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies 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
- Participants will be randomly divided into two groups (control and exercise) for treatment.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyda TOPRAK CELENAY, Ataturk Training and Research Hospital
- Investigators
- Seyda Toprak Celenay, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759391
- Sponsor's protocol ID
- 2021/02/15
- Status last verified
- Feb 2021
- First submitted
- 15 Feb 2021
- Last updated
- 18 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Digital Pelvic Floor Muscle Training and Lifestyle Recommendations in Patients With Multiple Sclerosis Having Lower Urinary Tract Symptoms
- ClinicalTrials.gov ID
- NCT04759391
- Acronym / sponsor ID
- 2021/02/15
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- Lower Urinary Tract Symptoms, Multiple Sclerosis, Pelvic Floor Muscle Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ataturk Training and Research HospitalUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 18 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 aim of this study was to investigate the effects of digital pelvic floor muscle training and lifestyle recommendations in patients with Multiple Sclerosis having lower urinary tract symptoms.
Detailed description
Multiple sclerosis (MS) is an autoimmune, neurodegenerative disease of the central nervous system. Lower urinary tract symptoms (LUTS) are very common in MS. Pelvic floor muscle training (PFMT) is one of the first-line choices for the conservative treatment of LUTS.
According to our knowledge, no study has investigated the effects of digital pelvic floor muscle training and lifestyle recommendations in MS having LUTS, yet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly divided into two groups (control and exercise) for treatment.
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Exercise, Other: Lifestyle recommendationsLifestyle recommendations as well as digital pelvic floor muscle training to the exercise group |
| Control group | Active comparator | Other: Lifestyle recommendationsLifestyle recommendations will be given to the control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Having a diagnosis of MS and having at least two of the lower urinary symptoms
- Not having an attack in the last 1 month,
- No change in medical treatment in the last 3 months
- "Expanded disability status scale-EDSS" score is less than 6.5
- Not having any cognitive problems that would hinder cooperation and understanding
Key exclusion criteria (7 listed)
- Pregnancy status
- Active urinary tract infection
- Another neurological disease that can cause incontinence
- A history of malignancy
- Prostate 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 |
|---|---|---|
| ExercisePelvic floor muscle training program planned under the supervision of a physiotherapist was applied and followed to the exercise group, using the digital application. | Other | Exercise group |
| Lifestyle recommendationsInformation was given within the scope of lifestyle recommendations (fluid intake, diet, constipation, weight control, smoking related to lower urinary system symptoms | Other | Control group, Exercise group |
Primary outcome
Incontinence symtoms
Time frame: change from baseline at 8 weeks
Urinary incontinence symptoms will be evaluated with The International Consultation of Incontinence Questionnaire - Short Form
Overactive bladder symptoms
Time frame: change from baseline at 8 weeks
Overactive bladder symptoms will be evaluated with Overactive Bladder Questionnaire-Version8
4 secondary outcomes
bladder functions
Time frame: change from baseline at 8 weeks
Quality of life level
Time frame: change from baseline at 8 weeks
subjective perception of improvement
Time frame: after treatment (8th week)
patient satisfaction
Time frame: after treatment (8th week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- 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.
Seyda Toprak Celenay principal investigator
Ankara Yildirim Beyazıt 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 Exercise and Lifestyle recommendations in people with Lower Urinary Tract Symptoms, run by Ataturk Training and Research Hospital 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seyda Toprak Celenay (+90312 906 1000, sydtoprak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incontinence symtoms (time frame: change from baseline at 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2021.