Lower Urinary Tract SymptomsNCT05824429
Connective Tissue Manipulation on Pelvic Floor Muscle Functions in Children
A study testing Urotherapy, Diaphragmatic Breathing Exercises and PFM Exercises in people with Lower Urinary Tract Symptoms, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
Lower urinary tract dysfunction (LUTD) is a disease group with subgroups that make up 40% of the patients were admitted to the pediatric urology clinic. The treatment of LUTD includes pharmacological, surgical treatment, neuromodulation, urotherapy, and pelvic floor muscle training. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Lower Urinary Tract Symptoms
- What is being tested?
- Urotherapy, Diaphragmatic Breathing Exercises and PFM Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2023to 1 Aug 2023
- 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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Be in the age range of 5-15 years
- Diagnosed with LUTD by a pediatric urologist according to the criteria set by the ICCS
- Volunteering by parent and child to participate in the study
Who cannot join
- Having any problems of neurogenic origin
- Any condition that affects the ability of the parent or child to respond to the scales to be used (mental retardation, cognitive problems, etc.)
- Malformations or anatomical differences in the urinary system
- Participants who discontinued treatment
- Presence of a urological surgery history
- Being on medication
- Having constipation and/or fecal incontinence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Connective Tissue Manipulation on Clinical Symptoms and Pelvic Floor Muscle Functions in Children With Lower Urinary Tract Dysfunction
Lower urinary tract dysfunction (LUTD) is a disease group with subgroups that make up 40% of the patients were admitted to the pediatric urology clinic. The treatment of LUTD includes pharmacological, surgical treatment, neuromodulation, urotherapy, and pelvic floor muscle training. Conservative methods include bladder training, changing lifestyle and eating habits, pharmacological treatment, and physiotherapy approaches.
Physiotherapy approaches used in the treatment of LUTD are; biofeedback, electrical stimulation applications, diaphragm breathing exercises, and manual therapy methods.
The aim of our study is to compare the effects of Connective Tissue Manipülation (CTM) , which will be applied in addition to Pelvic Floor Muscle Rehabilitation (PFMR) for 8 weeks, on LUTD symptoms, pelvic floor muscle functions, uroflowmetry values and quality of life compared to PTMR applied alone for 8 weeks in children with LUTD.
Read the detailed description
LUTD is clinical without any neuropathy; It refers to conditions that occur with symptoms such as urinary incontinence, urgency, increased or decreased urination during the day, dysuria, difficulty in starting to void, and the feeling of not being able to empty the bladder adequately.
Pelvic floor muscles (PFM) are known to be involved in the pathophysiology of LUTD. PFM needs to function normally during both the storage and voiding phase. In the literature, there are studies with positive results using PFM exercises in the treatment of symptoms in children with LUTD.
Connective Tissue Manipulation (CTM) can also be used within the scope of physiotherapy approaches that can be applied in children with LUTD. CTM is a reflex treatment technique that is applied manually by physiotherapists to the skin area and acts on some cells and connective tissue by making short and long pulls. Although the mechanism of action of CTM has not been fully elucidated, it is known to reduce organ dysfunctions by maintaining the balance between the parasympathetic and sympathetic components of the autonomic nervous system through segmental and supra-segmental cutaneous reflex pathways.
We think that CTM applied in addition to PFMR in the pediatric population can reduce LUTD symptoms by restoring the autonomic nervous system balance and increasing vascularity in the bladder. Therefore, the aim of our study is to compare the effects of CTM, which will be applied in addition to PFMR in children with LUTD, on LUTD symptoms, pelvic floor muscle functions, uroflowmetry values, and quality of life compared to PTCR applied alone.
- Conditions
- Lower Urinary Tract Symptoms
- Being tested
- Urotherapy, Diaphragmatic Breathing Exercises, PFM Exercises, Connective Tissue Manipulation
- Keywords
- Pelvic Floor, Urinary Incontinence, Connective Tissue
- Medical subject headings
- Lower Urinary Tract Symptoms, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UrotherapyOther
Urotherapy is an umbrella term that includes components such as information about bladder function and problem, lifestyle changes including the regulation of voiding and fluid intake times, correct toilet positions, information about bladder irritants, and motivation. All participants included in our study will be given urotherapy training before starting PFM exercises and CTM with their families.
Diaphragmatic Breathing ExercisesOther
In our research, diaphragm breathing exercises will be applied to both groups before starting PFM exercises in sessions for 8 weeks, 3 days a week.
PFM ExercisesOther
PFM exercises will be started after children learn to contract and relax their PFM in isolation without the use of auxiliary muscles. In the exercises, fast and slow contractions targeting type 1 and type 2 muscle fibers will be taught to increase both strength and endurance of PFM.
Connective Tissue ManipulationOther
CTM is a reflex treatment technique that is applied manually by physiotherapists to the skin area and acts on some cells and connective tissue by making short and long pulls (. In our study, CTM will be applied to our study group, where CTM and PFMR will be applied together, 3 days a week, for a total of 8 weeks.
The application will be made to the basic region (sacral), lower thoracic, abdominal and anterior pelvic region.
| Study group | Role | What they receive |
|---|---|---|
| Connective Tissue Manipulation Group | Experimental | Urotheraphy Diaphragmatic Breathing Exercises Pelvic Floor Muscle Exercise Connective Tissue Manipülation Receives: Other: Urotherapy; Other: Diaphragmatic Breathing Exercises; Other: PFM Exercises; Other: Connective Tissue Manipulation |
| Control Group | Active comparator | Urotheraphy Diaphragmatic Breathing Exercises Pelvic Floor Muscle Exercise Receives: Other: Urotherapy; Other: Diaphragmatic Breathing Exercises; Other: PFM Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
EMG- Uroflowmetry
In the uroflowmetry evaluation to be applied in our study, in case the patient's urge to urinate occurs, urination will be requested into the AYMED® brand EMG uroflowmetry container with a sensor system.
Measured: 8 weeks
Pelvic Floor Muscle Activation Assestment
In our study, the PTM activation values of the participants will be measured by the physiotherapist before and after the treatment using the NeuroTrac Myoplus4 Pro device.
Measured: 8 weeks
Bladder Diary
Thanks to the diary, parameters such as the child's daytime voiding frequency and volume, the amount and type of fluid taken, the duration of voiding, the presence of a sense of urgency, and the degree of urinary incontinence can be evaluated.In our study, the parents of the children will be trained by the physiotherapist to fill the bladder diary correctly, and they will be asked to fill in the 48-day voiding chart
Measured: 8 weeks
Dysfunctional Voiding and Incontinence Scoring System (DVISS)
It is a questionnaire that evaluates the severity of lower urinary tract dysfunctions and is completed by parents. DVISS questions for all participants before and after the treatment will be filled by the physiotherapist by reading each question to the parents one by one.
Measured: 8 weeks
Clinical Symtoms Information Form
Clinical symptoms will be recorded by the pediatric urologist by asking questions to the families and children and taking a detailed history during the face-to-face interview.
Measured: 8 weeks
Secondary outcomes (3)
Post-Voiding Residue (PVR)
With pelvic ultrasound, the bladder volume, the amount of urine in the bladder before voiding and the amount of urine remaining in the bladder after voiding can be evaluated.
Measured: 8 weeks
Pediatric Incontinance Questionnaire (PinQ)
Bower et al. developed the PinQ scale in 2005 for use in children with urinary incontinence.In our study, the PinQ scale will be filled in by the physiotherapist before and after the treatment by reading each question to the children one by one.
Measured: 8 weeks
Connective Tissue Evaluation
In our study, the responses of connective tissue inspection,palpation and circulation will be evaluated by examining both before and after treatment in the group in which PFMR will be applied only with CTM.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start5 May 2023
- Primary completion5 Jul 2023
- Study completion1 Aug 2023
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
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Tugtepe Pediatric Urology Clinic
- Responsible party
- Principal investigator, Melis ünal, Yeditepe University
- Investigators
- Halil Tuğtepe, Prof Dr, Study chair, Tugtepe Pediatric Urology CenterMelis Ünal, PT, Study director, Tugtepe Pediatric Urology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824429
- Sponsor's protocol ID
- MelisU
- Status last verified
- Mar 2024
- First submitted
- 5 Apr 2023
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- 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 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Connective Tissue Manipulation on Clinical Symptoms and Pelvic Floor Muscle Functions in Children With Lower Urinary Tract Dysfunction
- ClinicalTrials.gov ID
- NCT05824429
- Acronym / sponsor ID
- MelisU
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- Pelvic Floor, Urinary Incontinence, Connective Tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Collaborators
- Tugtepe Pediatric Urology Clinic
- Study start
- 5 May 2023 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 21 Apr 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.
Lower urinary tract dysfunction (LUTD) is a disease group with subgroups that make up 40% of the patients were admitted to the pediatric urology clinic. The treatment of LUTD includes pharmacological, surgical treatment, neuromodulation, urotherapy, and pelvic floor muscle training. Conservative methods include bladder training, changing lifestyle and eating habits, pharmacological treatment, and physiotherapy approaches.
Physiotherapy approaches used in the treatment of LUTD are; biofeedback, electrical stimulation applications, diaphragm breathing exercises, and manual therapy methods.
The aim of our study is to compare the effects of Connective Tissue Manipülation (CTM) , which will be applied in addition to Pelvic Floor Muscle Rehabilitation (PFMR) for 8 weeks, on LUTD symptoms, pelvic floor muscle functions, uroflowmetry values and quality of life compared to PTMR applied alone for 8 weeks in children with LUTD.
Detailed description
LUTD is clinical without any neuropathy; It refers to conditions that occur with symptoms such as urinary incontinence, urgency, increased or decreased urination during the day, dysuria, difficulty in starting to void, and the feeling of not being able to empty the bladder adequately.
Pelvic floor muscles (PFM) are known to be involved in the pathophysiology of LUTD. PFM needs to function normally during both the storage and voiding phase. In the literature, there are studies with positive results using PFM exercises in the treatment of symptoms in children with LUTD.
Connective Tissue Manipulation (CTM) can also be used within the scope of physiotherapy approaches that can be applied in children with LUTD. CTM is a reflex treatment technique that is applied manually by physiotherapists to the skin area and acts on some cells and connective tissue by making short and long pulls. Although the mechanism of action of CTM has not been fully elucidated, it is known to reduce organ dysfunctions by maintaining the balance between the parasympathetic and sympathetic components of the autonomic nervous system through segmental and supra-segmental cutaneous reflex pathways.
We think that CTM applied in addition to PFMR in the pediatric population can reduce LUTD symptoms by restoring the autonomic nervous system balance and increasing vascularity in the bladder. Therefore, the aim of our study is to compare the effects of CTM, which will be applied in addition to PFMR in children with LUTD, on LUTD symptoms, pelvic floor muscle functions, uroflowmetry values, and quality of life compared to PTCR applied alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connective Tissue Manipulation Group | Experimental | Other: Urotherapy, Other: Diaphragmatic Breathing Exercises, Other: PFM Exercises, Other: Connective Tissue ManipulationUrotheraphy Diaphragmatic Breathing Exercises Pelvic Floor Muscle Exercise Connective Tissue Manipülation |
| Control Group | Active comparator | Other: Urotherapy, Other: Diaphragmatic Breathing Exercises, Other: PFM ExercisesUrotheraphy Diaphragmatic Breathing Exercises Pelvic Floor Muscle Exercise |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Be in the age range of 5-15 years
- Diagnosed with LUTD by a pediatric urologist according to the criteria set by the ICCS
- Volunteering by parent and child to participate in the study
Key exclusion criteria (7 listed)
- Having any problems of neurogenic origin
- Any condition that affects the ability of the parent or child to respond to the scales to be used (mental retardation, cognitive problems, etc.)
- Malformations or anatomical differences in the urinary system
- Participants who discontinued treatment
- Presence of a urological surgery history
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 |
|---|---|---|
| UrotherapyUrotherapy is an umbrella term that includes components such as information about bladder function and problem, lifestyle changes including the regulation of voiding and fluid intake times, correct toilet positions, information about bladder irritants, and motivation. All participants included in our study will be given urotherapy training before starting PFM exercises and CTM with their families. | Other | Connective Tissue Manipulation Group, Control Group |
| Diaphragmatic Breathing ExercisesIn our research, diaphragm breathing exercises will be applied to both groups before starting PFM exercises in sessions for 8 weeks, 3 days a week. | Other | Connective Tissue Manipulation Group, Control Group |
| PFM ExercisesPFM exercises will be started after children learn to contract and relax their PFM in isolation without the use of auxiliary muscles. In the exercises, fast and slow contractions targeting type 1 and type 2 muscle fibers will be taught to increase both strength and endurance of PFM. | Other | Connective Tissue Manipulation Group, Control Group |
| Connective Tissue ManipulationCTM is a reflex treatment technique that is applied manually by physiotherapists to the skin area and acts on some cells and connective tissue by making short and long pulls (. In our study, CTM will be applied to our study group, where CTM and PFMR will be applied together, 3 days a week, for a total of 8 weeks. The application will be made to the basic region (sacral), lower thoracic, abdominal and anterior pelvic region. | Other | Connective Tissue Manipulation Group |
Primary outcome
EMG- Uroflowmetry
Time frame: 8 weeks
In the uroflowmetry evaluation to be applied in our study, in case the patient's urge to urinate occurs, urination will be requested into the AYMED® brand EMG uroflowmetry container with a sensor system.
Pelvic Floor Muscle Activation Assestment
Time frame: 8 weeks
In our study, the PTM activation values of the participants will be measured by the physiotherapist before and after the treatment using the NeuroTrac Myoplus4 Pro device.
Bladder Diary
Time frame: 8 weeks
Thanks to the diary, parameters such as the child's daytime voiding frequency and volume, the amount and type of fluid taken, the duration of voiding, the presence of a sense of urgency, and the degree of urinary incontinence can be evaluated.In our study, the parents of the children will be trained by the physiotherapist to fill the bladder diary correctly, and they will be asked to fill in the 48-day voiding chart
Dysfunctional Voiding and Incontinence Scoring System (DVISS)
Time frame: 8 weeks
It is a questionnaire that evaluates the severity of lower urinary tract dysfunctions and is completed by parents. DVISS questions for all participants before and after the treatment will be filled by the physiotherapist by reading each question to the parents one by one.
Clinical Symtoms Information Form
Time frame: 8 weeks
Clinical symptoms will be recorded by the pediatric urologist by asking questions to the families and children and taking a detailed history during the face-to-face interview.
3 secondary outcomes
Post-Voiding Residue (PVR)
Time frame: 8 weeks
Pediatric Incontinance Questionnaire (PinQ)
Time frame: 8 weeks
Connective Tissue Evaluation
Time frame: 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 2024.
- 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.
Halil Tuğtepe, Prof Dr study chair
Tugtepe Pediatric Urology Center
Melis Ünal, PT study director
Tugtepe Pediatric Urology Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urotherapy, Diaphragmatic Breathing Exercises and PFM Exercises in people with Lower Urinary Tract Symptoms, run by Yeditepe 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 3 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: finished, as of the sponsor's last update on 29 Mar 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 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?
EMG- Uroflowmetry (time frame: 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?
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 2024.