Bladder DysfunctionNCT05351138
Comparison of Transcutaneous Electrical Nerve Stimulation and Manual Therapy in Children With Cerebral Palsy
A study testing TENS and Massage in people with Bladder Dysfunction and Bowel Dysfunction, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
There are many studies in the literature on healthy children with lower urinary tract dysfunction (LUTD), but there are limited number of studies in children with cerebral palsy (CP) with LUTD. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Bladder Dysfunction, Bowel Dysfunction, Cerebral Palsy
- What is being tested?
- TENS and Massage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2023to 1 Nov 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Being between the ages of 5-18
- Diagnosed with Cerebral Palsy
- Having one of the Gross Motor Function Classification System I, II, III and IV grades
- Having a complaint of urinary incontinence
Who cannot join
- Being younger than 5 years old
- Being level V according to Gross Motor Function Classification System
- Having uncontrolled epileptic seizures
- Anatomical changes in the urinary system
- Having cognitive disability
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pelin Pişirici
Istanbul, Besiktas/Istanbul, 34353
About this study
Official title: Comparison the Efficiency of Transcutaneous Electrical Nerve Stimulation and Manual Therapy in Children With Cerebral Palsy With Lower Urinary System Dysfunction
There are many studies in the literature on healthy children with lower urinary tract dysfunction (LUTD), but there are limited number of studies in children with cerebral palsy (CP) with LUTD.
This study aim to contribute to the literature by examining the effectiveness of transcutaneous electrical nerve stimulation (TENS) and abdominal massage in the treatment of children with CP with LUTD and comparing the superiority of the two treatment methods to each other.
Read the detailed description
CP represents a group of chronic, non-progressive motor disorders characterized by impaired voluntary movement resulting from prenatal developmental abnormalities or perinatal or postnatal central nervous system damage.
The location and extent of neurological damage are important in determining motor and mental disabilities and the severity of the disease. Children with CP can also be affected by other medical disorders such as seizures, mental retardation, hearing, vision and communication problems. The prevalence of CP is approximately 2-3 per 1000 live births. Dysfunctional bowel and urinary dysfunction problems can often accompany CP due to motor, mental, cognitive, sensory and other neurological disorders. Severe motor disorders and/or additional cognitive deficits lead to the development of neurogenic lower urinary tract symptoms. Accoring the data obtained during the outpatient clinic visits, it was determined that most of the children with CP had LUTD complaints such as incontinence, sense of urgency, difficulty urinating, urinary retention and urinary tract infections. These urological problems affect approximately one-third of children with CP, and the prevalence of dysfunctional voiding symptoms such as pollakisuria, incontinence or urinary tract infections is estimated to be more than 30% in the population.
TENS therapy is classified as a neuromodulation therapy. In the last few years, it has been shown in the literature TENS gives positive results in the treatment of urinary symptoms.
Abdominal massage, which is one of the manual therapy techniques; the anterior abdominal wall reduces abdominal muscle tension, increases local circulation, facilitates digestion and stimulates gastric acid secretion, stimulates colonic movements by providing peristaltic stimulation. It is a classical massage method that includes clockwise manual movements over the area where the colon is located. In abdominal massage, by manually applying pressure from the anterior abdominal wall, the digestive organs are compressed between the fingers and the posterior abdominal wall and peristaltic stimulation is created. Hence, stool is pushed from the colon into the rectum. In addition, abdominal massage reduces the severity of constipation symptoms by reducing abdominal bloating and treating trigger points in the abdominal muscles.
This study aim to contribute to the literature by examining the effectiveness of TENS and abdominal massage in the treatment of children with CP with LUTD and comparing the superiority of the two treatment methods to each other.
- Conditions
- Bladder Dysfunction, Bowel Dysfunction, Cerebral Palsy, Neurogenic Bladder, Neurogenic Bowel
- Being tested
- TENS, Massage
- Keywords
- Neuromodulation therapy, Urinary incontinence, Constipation, Voiding disorder, Abdominal massage
- Medical subject headings
- Intestinal Diseases, Cerebral Palsy, Urinary Bladder, Neurogenic, Neurogenic Bowel, Urinary Incontinence, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
In the study, CE certified tens device with Biolito brand, which is used specifically for incontinence treatment, will be used. The electrodes used during the intervention will be placed to the parasacral region (S2-S4). While the current is given, the power of the device will be gradually increased in 1 mA intervals. The lower value of the stimulation will be 10 mA and the upper value will be 25 mA, and the treatment will be continued with any value that the child can tolerate in this range.
MassageOther
The massage will be applied to the abdominal area between the subcostal lower border and the anterior superior of the spina iliaca. Massage techniques are as follows: Abdominal patting, colon patting, colon kneading, colon patting again, abdominal patting again. It will be advanced with deep abdominal strokes, then the starting point will be returned with transverse superficial strokes for the transversus abdominis muscle and oblique superficial strokes for the rectus abdominis muscle, and these strokes will be repeated 3 times each, a total of 6 times. Afterwards, 3 times column brushing, 3 times column kneading and 3 times column plastering will be done, respectively. At the end, a total of 6 abdominal strokes will be performed for both the transversus abdominis and oblique abdominal muscles as in the beginning.
| Study group | Role | What they receive |
|---|---|---|
| TENS Group | Experimental | Transcutaneus electric nerve stimulation intervention will be done for a total of 12 weeks, 2 sessions of 20 minutes per week. Receives: Device: TENS |
| Masaj Group | Experimental | Massage intervention will be done in the form of massage practise to the abdominal region, 2 sessions of 20 minutes per week. Receives: Other: Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voiding Disorders Symptom Scoring
Voiding Disorders Symptom Scoring was developed in 2005 and includes 13 questions about symptoms and 1 question about quality of life .
The scale is for parents and scoring is done according to the answers from the parents. The total score is between 0-35 points. As the score obtained from the scale increases, the severity of the patient's symptoms also increases.
Measured: Change from Baseline at 12th week
Secondary outcomes (4)
Bladder Diary
The bladder diary is a simple and non-invasive method of assessing people with lower urinary tract symptoms. The International Children's Continence Society has proposed a chart to assess lower urinary tract dysfunction, showing 48-hour daytime voiding frequency, voiding volume, voiding duration, presence of urgency, type and amount of fluid intake, and degree of urinary incontinence.
Measured: Change from Baseline at 12th week
Pediatric Incontinence Quality of Life Scale
Pediatric Incontinence Quality of Life Scale is the first continence quality of life scale developed in the pediatric population. It is a continence-specific quality of life scale developed for children and adolescents in 2006. The Turkish validity and reliability study was performed in 2011.
In the initial development stages of the PINQ scale, it was developed as 28 questions including 7 dimensions that evaluate children's social relations with their peers, self-esteem, family and home relations, body image, independence, mental health and treatment. In the following studies, these dimensions were grouped into two as Extrinsic (extrinsic) and Intrinsic (intrinsic), and finally the number of questions was arranged as 20. Each question is given a score of 0 (no), 1 (almost never), 2 (sometimes), 3 (often), 4 (always), and a total score (0-80) is calculated. An increase in the total score indicates that the patient's quality of life worsens .
Measured: Change from Baseline at 12th week
Rome IV Criteria
Rome IV criteria allow to detect the presence of constipation in toilet trained or untrained children. Abdominal pain that recurs at least once a week in the last 3 months; If defecation is associated with at least two of the symptoms of a change in the frequency of pooping and a change in the form of poop, constipation is present according to the Rome 4 criteria.
Measured: Change from Baseline at 12th week
Bristol Stool Scale
The Bristol Stool Scale (BSS) was developed by Lewis and Heaton at the University of Bristol in 1990 and classifies human faeces into 7 groups. The shape of the stool changes according to the time it stays in the colon. The BSS is a fast and reliable indicator of transit time. There are 7 different poop forms on the Bristol stool scale. Types 3 and 4 correspond to the normal poop form. Types 1 and 2 show that the person has symptoms of constipation. Tip 5,6,7 corresponds to (in order) lack of fiber, mild diarrhea and severe diarrhea.
Measured: Change from Baseline at 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start30 Jan 2023
- Primary completion1 Sep 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder DysfunctionStudies 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
- Children between the ages of 5-18, diagnosed with CP with LUTD who met the inclusion criteria will be included in the study. Sample size of the study is calculated as 54. All evaluations of the participants will be done by the specialist physiotherapist who made the evaluations would not know which treatment method was applied to the participants and would be a blind evaluator.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Collaborators
- Tugtepe Pediatric Urology Clinic
- Responsible party
- Principal investigator, Pelin Pişirici, Bahçeşehir University
- Investigators
- Betül Ünal, PT, Principal investigator, Bahçeşehir University, Graduate Education Institute, Physical Therapy and RehabilitationPelin Pişirici, PT, PHD, Study director, Bahçeşehir University, Health Sciences Faculty, Physiotherapy and Rehabilitation DepartmentHalil Tuğtepe, MD, Prof., Study chair, Private Tuğtepe Pediatric Urology and Surgery ClinicAygül Köseoğlu, PT, Msc, Study chair, Private Tuğtepe Pediatric Urology and Surgery Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351138
- Sponsor's protocol ID
- BBD-TUGTEPE-130422
- Status last verified
- Jan 2024
- First submitted
- 13 Apr 2022
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison the Efficiency of Transcutaneous Electrical Nerve Stimulation and Manual Therapy in Children With Cerebral Palsy With Lower Urinary System Dysfunction
- ClinicalTrials.gov ID
- NCT05351138
- Acronym / sponsor ID
- BBD-TUGTEPE-130422
- Conditions
- Bladder Dysfunction, Bowel Dysfunction, Cerebral Palsy, Neurogenic Bladder, Neurogenic Bowel
- Keywords
- Neuromodulation therapy, Urinary incontinence, Constipation, Voiding disorder, Abdominal massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Collaborators
- Tugtepe Pediatric Urology Clinic
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 28 Apr 2022 (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.
There are many studies in the literature on healthy children with lower urinary tract dysfunction (LUTD), but there are limited number of studies in children with cerebral palsy (CP) with LUTD.
This study aim to contribute to the literature by examining the effectiveness of transcutaneous electrical nerve stimulation (TENS) and abdominal massage in the treatment of children with CP with LUTD and comparing the superiority of the two treatment methods to each other.
Detailed description
CP represents a group of chronic, non-progressive motor disorders characterized by impaired voluntary movement resulting from prenatal developmental abnormalities or perinatal or postnatal central nervous system damage.
The location and extent of neurological damage are important in determining motor and mental disabilities and the severity of the disease. Children with CP can also be affected by other medical disorders such as seizures, mental retardation, hearing, vision and communication problems. The prevalence of CP is approximately 2-3 per 1000 live births. Dysfunctional bowel and urinary dysfunction problems can often accompany CP due to motor, mental, cognitive, sensory and other neurological disorders. Severe motor disorders and/or additional cognitive deficits lead to the development of neurogenic lower urinary tract symptoms. Accoring the data obtained during the outpatient clinic visits, it was determined that most of the children with CP had LUTD complaints such as incontinence, sense of urgency, difficulty urinating, urinary retention and urinary tract infections. These urological problems affect approximately one-third of children with CP, and the prevalence of dysfunctional voiding symptoms such as pollakisuria, incontinence or urinary tract infections is estimated to be more than 30% in the population.
TENS therapy is classified as a neuromodulation therapy. In the last few years, it has been shown in the literature TENS gives positive results in the treatment of urinary symptoms.
Abdominal massage, which is one of the manual therapy techniques; the anterior abdominal wall reduces abdominal muscle tension, increases local circulation, facilitates digestion and stimulates gastric acid secretion, stimulates colonic movements by providing peristaltic stimulation. It is a classical massage method that includes clockwise manual movements over the area where the colon is located. In abdominal massage, by manually applying pressure from the anterior abdominal wall, the digestive organs are compressed between the fingers and the posterior abdominal wall and peristaltic stimulation is created. Hence, stool is pushed from the colon into the rectum. In addition, abdominal massage reduces the severity of constipation symptoms by reducing abdominal bloating and treating trigger points in the abdominal muscles.
This study aim to contribute to the literature by examining the effectiveness of TENS and abdominal massage in the treatment of children with CP with LUTD and comparing the superiority of the two treatment methods to each other.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Children between the ages of 5-18, diagnosed with CP with LUTD who met the inclusion criteria will be included in the study. Sample size of the study is calculated as 54. All evaluations of the participants will be done by the specialist physiotherapist who made the evaluations would not know which treatment method was applied to the participants and would be a blind evaluator.
| Arm | Type | Receives |
|---|---|---|
| TENS Group | Experimental | Device: TENSTranscutaneus electric nerve stimulation intervention will be done for a total of 12 weeks, 2 sessions of 20 minutes per week. |
| Masaj Group | Experimental | Other: MassageMassage intervention will be done in the form of massage practise to the abdominal region, 2 sessions of 20 minutes per week. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Being between the ages of 5-18
- Diagnosed with Cerebral Palsy
- Having one of the Gross Motor Function Classification System I, II, III and IV grades
- Having a complaint of urinary incontinence
Key exclusion criteria (5 listed)
- Being younger than 5 years old
- Being level V according to Gross Motor Function Classification System
- Having uncontrolled epileptic seizures
- Anatomical changes in the urinary system
- Having cognitive disability
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 |
|---|---|---|
| TENSIn the study, CE certified tens device with Biolito brand, which is used specifically for incontinence treatment, will be used. The electrodes used during the intervention will be placed to the parasacral region (S2-S4). While the current is given, the power of the device will be gradually increased in 1 mA intervals. The lower value of the stimulation will be 10 mA and the upper value will be 25 mA, and the treatment will be continued with any value that the child can tolerate in this range. | Device | TENS Group |
| MassageThe massage will be applied to the abdominal area between the subcostal lower border and the anterior superior of the spina iliaca. Massage techniques are as follows: Abdominal patting, colon patting, colon kneading, colon patting again, abdominal patting again. It will be advanced with deep abdominal strokes, then the starting point will be returned with transverse superficial strokes for the transversus abdominis muscle and oblique superficial strokes for the rectus abdominis muscle, and these strokes will be repeated 3 times each, a total of 6 times. Afterwards, 3 times column brushing, 3 times column kneading and 3 times column plastering will be done, respectively. At the end, a total of 6 abdominal strokes will be performed for both the transversus abdominis and oblique abdominal muscles as in the beginning. | Other | Masaj Group |
Primary outcome
Voiding Disorders Symptom Scoring
Time frame: Change from Baseline at 12th week
Voiding Disorders Symptom Scoring was developed in 2005 and includes 13 questions about symptoms and 1 question about quality of life . The scale is for parents and scoring is done according to the answers from the parents. The total score is between 0-35 points. As the score obtained from the scale increases, the severity of the patient's symptoms also increases.
4 secondary outcomes
Bladder Diary
Time frame: Change from Baseline at 12th week
Pediatric Incontinence Quality of Life Scale
Time frame: Change from Baseline at 12th week
Rome IV Criteria
Time frame: Change from Baseline at 12th week
Bristol Stool Scale
Time frame: Change from Baseline at 12th week
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 Jan 2024.
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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.
Betül Ünal, PT principal investigator
Bahçeşehir University, Graduate Education Institute, Physical Therapy and Rehabilitation
Pelin Pişirici, PT, PHD study director
Bahçeşehir University, Health Sciences Faculty, Physiotherapy and Rehabilitation Department
Halil Tuğtepe, MD, Prof. study chair
Private Tuğtepe Pediatric Urology and Surgery Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS and Massage in people with Bladder Dysfunction and Bowel Dysfunction, run by Bahçeşehir 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 5 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 Jan 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?
Voiding Disorders Symptom Scoring (time frame: Change from Baseline at 12th week). 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 Jan 2024.