Bladder and Bowel Dysfunction, Femoral AnteversionNCT05182671
Relationship Between Pelvic Angle, Femoral Anteversion, and Hip Muscle Strength Ratios in Bladder-bowel Dysfunction
An observational study of Bladder and Bowel Dysfunction, Femoral Anteversion and Bladder and Bowel Dysfunction, Hip Strength Ratios, run by Halil Tugtepe at 1 site in Turkey (Türkiye).
Trial summary
Bladder and bowel dysfunction is a combination of lower urinary tract and bowel dysfunction seen in children over 5 years of age without identifiable or discernible neurological abnormalities. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Bladder and Bowel Dysfunction, Femoral Anteversion, Bladder and Bowel Dysfunction, Hip Strength Ratios, Bladder and Bowel Dysfunction, Pelvic Angle
- What is being tested?
- Scales and measurements for bladder and bowel dysfunction, pelvic angle, proximal hip strength, femoral hip anteversion
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2022to 9 Feb 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children who are between 5-12 years old, diagnosed with bladder bowel dysfunction.
Who may be able to join
- To be between the ages of 5-12
- To be diagnosed with bladder- bowel dysfunction
Who cannot join
- To be younger than 5 years old
- To have an orthopedic disease that would prevent the evaluation
- To have anatomical changes in the urinary system
- To have having a neurological disorder
- To have cognitive impairment and mental retardation
- To have an orthopedic surgery that can change pelvis and lower extremity biomechanics
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Private Tugtepe Pediatric Urology Clinic
Istanbul, 34353
About this study
Official title: Relationship Between Pelvic Angle, Femoral Anteversion, and Hip Muscle Strength Ratios in Children With Bladder-bowel Dysfunction
Bladder and bowel dysfunction is a combination of lower urinary tract and bowel dysfunction seen in children over 5 years of age without identifiable or discernible neurological abnormalities. The proper functioning of the bladder, bowel, nerves, pelvic floor muscles and related anatomical structures provides the bowel and lower urinary tract function. Dysfunction of any structure of the pelvic floor can potentially cause to bladder and bowel dysfunction. The ability of the pelvic floor muscles to perform the correct contraction and relaxation function is also closely related to the position of the pelvis, muscle strength of the hip muscles, and femoral anteversion. Disruption of one of the links forming the chain causes a change in the mobility and stability of all mechanically related structures and may affect the optimal force that the pelvic floor muscles can produce.
As far as investigators know, there is no study in the literature examining the relationship between BBD and pelvic angle, femoral anteversion angle, femoral internal/external rotation angle ratio and hip muscle strength ratios in children with bladder-bowel dysfunction. Considering the close relationship between pelvis position, hip muscle strength, and femoral anteversion with the pelvic floor, investigators think that this relationship should be evaluated in children with BBD and will contribute to the literature.
Read the detailed description
Bladder and bowel dysfunction (BBD) is a combination of lower urinary tract (LUT) and bowel dysfunction seen in children over 5 years of age without identifiable or discernible neurological abnormalities. Constipation and fecal incontinence are common bowel dysfunctions. Common lower urinary tract dysfunction (LUTD) symptoms of BBD include dysuria, urgency, urinary frequency, difficulty in initiating urine, daytime incontinence, enuresis, straining, delayed voiding, and urinary retention. Urological conditions such as overactive bladder, underactive bladder and dysfunctional voiding can also be part of BBD.
The proper functioning of the bladder, bowel, nerves, pelvic floor muscles and related anatomical structures provides the bowel and LUT function. The pelvic floor is a structure located at the base of the pelvis, consisting of smooth and striated muscle sphincters, endopelvic fascia, connective tissue and ligaments, mucosal and vascular tissues, levator ani and more superficial perineal muscles. It actively supports the pelvic organs (bladder, bowel, uterus) and provides continence. Dysfunction of any structure of the pelvic floor can potentially cause to bladder and bowel dysfunction.
The ability of the pelvic floor muscles to perform the correct contraction and relaxation function is also closely related to the position of the pelvis, muscle strength of the hip muscles, and femoral anteversion. The pelvis and lower extremity consist of interconnected closed chain structures. The movement of any link in the chain depends on the movement of the other links. For this reason, disruption of one of the links forming the chain causes a change in the mobility and stability of all mechanically related structures and may affect the optimal force that the pelvic floor muscles can produce.
As far as investigators know, there is no study in the literature examining the relationship between BBD and pelvic angle, femoral anteversion angle, femoral internal/external rotation angle ratio and hip muscle strength ratios in children with bladder-bowel dysfunction. Considering the close relationship between pelvis position, hip muscle strength, and femoral anteversion with the pelvic floor, investigators think that this relationship should be evaluated in children with BBD and will contribute to the literature.
- Conditions
- Bladder and Bowel Dysfunction, Femoral Anteversion, Bladder and Bowel Dysfunction, Hip Strength Ratios, Bladder and Bowel Dysfunction, Pelvic Angle
- Being tested
- Scales and measurements for bladder and bowel dysfunction, pelvic angle, proximal hip strength, femoral hip anteversion
- Medical subject headings
- Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scales and measurements for bladder and bowel dysfunction, pelvic angle, proximal hip strength, femoral hip anteversionOther
Assessments Children whose physical examination has been completed and diagnosed with BBD will be evaluated with following assessments.
Demographic Data Form Questionnaire Forms Dysfunctional Voiding and Incontinence Scoring System Bladder Diary Bowel Diary EMG-uroflowmetry Ultrasonography
Post Voiding Residual Measurement:
Bladder wall thickness
Pelvic Floor Muscle Activation Measurement:
Pelvic Floor Muscle Strength Assessment:
Hip agonist-antagonist muscle ratios Pelvic angle measurement Femoral anteversiyon angle measurement
Femoral internal and external rotation angle:
| Study group | Role | What they receive |
|---|---|---|
| Children diagnosed with bowel and bladder dysfunction | Children who are between the ages of 5-12 and diagnosed with bladder- bowel dysfunction by pediatric urologist. Receives: Other: Scales and measurements for bladder and bowel dysfunction, pelvic angle, proximal hip strength, femoral hip anteversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Femoral anteversion angle measurement
Hip anteversion was measured using the Craig test with the subject in the prone position and the knee flexed to 90°. The examiner passively rotates the hip, palpating the trochanter major, until the most prominent part of the trochanter reaches its most lateral position. The angle between the true vertical and the shaft of the tibia was measured to the nearest degree, using a Accurate Compass smartphone inclinometer.
Measured: Baseline
Pelvic angle measurement
The inferior prominence of the anterior superior iliac spine (ASIS) and the most prominent aspect of the posterior superior iliac spine (PSIS) were identified with palpation, and pelvic angle was measured as the angle formed between the horizontal plane and a line from ASIS and PSIS landmarks using an inclinometer (Performance Attainment Associates, St Paul, MN). A positive value reflected an anterior pelvic tilt (ASIS sitting lower than the PSIS).
Measured: Baseline
Hip agonist-antagonist muscle ratios
In the isometric muscle strength measurement procedure, each test position was evaluated with 2 repetitions of submaximal force for familiarization and 3 evaluations were taken with maximal force. Each test lasted 5 seconds, with 30-second breaks between trials. A 1-minute break was given between different measurements. MicroFET(Draper, UT) hand dynamometer was used for muscle strength measurement. The order of strength testing was randomized. The dynamometer is fixed to the leg with the help of a strap. Force values are measured in kilograms and normalized to body mass using the following formula:(kg power/kg body mass)x100. The intrarater reliability study will be completed before participants' measurements begin to be taken. Hip abductor, adductor, flexor, extensor, internal rotation, external rotation muscle strength is measured. Hip adductor/abductor, medial/lateral rotator, and flexor/extensor strength ratios muscle strength ratios will be evaluated.
Measured: Baseline
Secondary outcomes (6)
Dysfunctional Voiding and Incontinence Scoring System
Dysfunctional Voiding and Incontinence Scoring System (DVISS) is a 13-item questionnaire. Parents are the target audience. DVISS scores are based on the estimated odds ratio for each question between cases and controls. For example, 1 point is awarded if the odds ratio value is between 2 and 10, and 5 points if it is greater than 50. The total score can range from 0 to 35. A cut-off value of 8.5 shows 90% specificity and sensitivity in detecting BBD.
Measured: Baseline
EMG-uroflowmetry
In the uroflowmetry evaluation, when the patient's urge to urinate occurs, urination will be requested into the AYMED® brand EMG uroflowmetry pot with a sensor system. Stool support will be provided to ensure suitable toilet position in children whose feet do not touch the ground during the test measurement. In order to minimize the external factors that will affect the voiding pattern, there will be no one other than the patient in the uroflowmetry room. The parameters obtained as a result of the measurement will enable us to interpret the bladder's emptying phase.
Measured: Baseline
Ultrasonography - Post Voiding Residual Measurement, Bladder thickness
Telemed® brand transabdominal ultrasound device will be used, and measurements will be made from the suprapubic region. During the measurement, the patient will be positioned in the supine position and the knees will be slightly flexed and supported with a towel under the knee. The volume values in mm3 calculated by the probe in the coronal and sagittal regions will be automatically multiplied by the ultrasound system and the residual urine remaining in the bladder will be calculated in cc. The standard method should be used for pelvic voiding residual measurements.
Measured: Baseline
Pelvic Floor Muscle Activation Measurement:
The pelvic floor physiotherapist positions the participant in the butterfly position with support under the legs while lying on their back. Before EMG evaluation, all participants are taught to perform isolated contraction and relaxation of the pelvic floor muscles without the use of accessory muscles by anus palpation. Two superficial electrodes (30 mm diameter (VS30)) are then placed bilaterally adjacent to the mucocutaneous line of the anus at 2 and 7 o'clock to prevent cross-talking (electrodes interference and artifact formation). The reference surface electrode is placed on the inside of the right thigh.
After proper placement of the electrodes, pelvic floor muscle activity will be measured with the NeuroTrac Myoplus4 Pro device.
Measured: Baseline
Pelvic Floor Muscle Strength Assessment:
Manual muscle testing is a subjective assessment method. First, the child is taught to contract the pelvic floor muscles in the litotomy position (supine, butterfly position). The therapist places the index finger on the anus (perceiving contraction of the external anal sphincter), asking child's to contract the pelvic floor muscles as if she were holding child's stool or urine. The therapist then asks the child to contract the pelvic floor muscles as the muscles teach the correct contraction.
With the manual muscle test, the strength, fatigue time and endurance of the pelvic floor muscles are evaluated. Evaluation of pelvic floor muscles in children is evaluated by palpation over the external anal sphincter, and the following grading method is used.
Modified Oxford Scale 0= no contraction
1= vibration 2 = weak contraction 2+= contraction without movement 3 = contraction with movement 3+= strong contraction
Measured: Baseline
Femoral internal and external rotation angle
Passive hip internal rotation and external rotation were measured with a standard goniometer, with the child lying face down on the table in the prone position. The thigh was carefully positioned to 0° hip abduction or adduction and the contralateral leg to approximately 20° abduction. Pelvis is stabilized by another physiotherapist and examiner measured range of motion by bringing the leg to a firm end point of both IR and ER. The measurement was made by passively bringing the leg to its end point in both internal and external rotation, without lifting the pelvis from the ground. Angle measurement will be made with Accurate Compass smartphone inclinometer.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start15 Jan 2022
- Primary completion1 Sep 2023
- Study completion9 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder and Bowel Dysfunction, Femoral AnteversionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Halil Tugtepe
- Sponsor type
- University, hospital or other
- Collaborators
- Bahçeşehir University
- Responsible party
- Sponsor-investigator, Halil Tugtepe, Tugtepe Pediatric Urology Clinic
- Investigators
- Aygül Köseoğlu, PT, MSc, Principal investigator, Tuğtepe Pediatric Urology ClinicHalil Tuğtepe, MD, Prof Dr,, Study chair, Tuğtepe Pediatric Urology ClinicPelin Pişirici, PT, PhD, Study director, Bahçeşehir University Faculty of Health SciencesTuğçe Atalay, PT, Study chair, Tuğtepe Pediatric Urology ClinicEce Zeynep Saatçi, PT, Study chair, Tuğtepe Pediatric Urology ClinicMelis Ünal, PT, Study chair, Tuğtepe Pediatric Urology Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182671
- Sponsor's protocol ID
- TUGTEPEPUC
- Status last verified
- Feb 2024
- First submitted
- 21 Nov 2021
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Pelvic Angle, Femoral Anteversion, and Hip Muscle Strength Ratios in Children With Bladder-bowel Dysfunction
- ClinicalTrials.gov ID
- NCT05182671
- Acronym / sponsor ID
- TUGTEPEPUC
- Conditions
- Bladder and Bowel Dysfunction, Femoral Anteversion, Bladder and Bowel Dysfunction, Hip Strength Ratios, Bladder and Bowel Dysfunction, Pelvic Angle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Halil TugtepeUniversity, hospital or other
- Collaborators
- Bahçeşehir University
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 9 Feb 2024 (actual)
- First posted
- 10 Jan 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.
Bladder and bowel dysfunction is a combination of lower urinary tract and bowel dysfunction seen in children over 5 years of age without identifiable or discernible neurological abnormalities. The proper functioning of the bladder, bowel, nerves, pelvic floor muscles and related anatomical structures provides the bowel and lower urinary tract function. Dysfunction of any structure of the pelvic floor can potentially cause to bladder and bowel dysfunction. The ability of the pelvic floor muscles to perform the correct contraction and relaxation function is also closely related to the position of the pelvis, muscle strength of the hip muscles, and femoral anteversion. Disruption of one of the links forming the chain causes a change in the mobility and stability of all mechanically related structures and may affect the optimal force that the pelvic floor muscles can produce.
As far as investigators know, there is no study in the literature examining the relationship between BBD and pelvic angle, femoral anteversion angle, femoral internal/external rotation angle ratio and hip muscle strength ratios in children with bladder-bowel dysfunction. Considering the close relationship between pelvis position, hip muscle strength, and femoral anteversion with the pelvic floor, investigators think that this relationship should be evaluated in children with BBD and will contribute to the literature.
Detailed description
Bladder and bowel dysfunction (BBD) is a combination of lower urinary tract (LUT) and bowel dysfunction seen in children over 5 years of age without identifiable or discernible neurological abnormalities. Constipation and fecal incontinence are common bowel dysfunctions. Common lower urinary tract dysfunction (LUTD) symptoms of BBD include dysuria, urgency, urinary frequency, difficulty in initiating urine, daytime incontinence, enuresis, straining, delayed voiding, and urinary retention. Urological conditions such as overactive bladder, underactive bladder and dysfunctional voiding can also be part of BBD.
The proper functioning of the bladder, bowel, nerves, pelvic floor muscles and related anatomical structures provides the bowel and LUT function. The pelvic floor is a structure located at the base of the pelvis, consisting of smooth and striated muscle sphincters, endopelvic fascia, connective tissue and ligaments, mucosal and vascular tissues, levator ani and more superficial perineal muscles. It actively supports the pelvic organs (bladder, bowel, uterus) and provides continence. Dysfunction of any structure of the pelvic floor can potentially cause to bladder and bowel dysfunction.
The ability of the pelvic floor muscles to perform the correct contraction and relaxation function is also closely related to the position of the pelvis, muscle strength of the hip muscles, and femoral anteversion. The pelvis and lower extremity consist of interconnected closed chain structures. The movement of any link in the chain depends on the movement of the other links. For this reason, disruption of one of the links forming the chain causes a change in the mobility and stability of all mechanically related structures and may affect the optimal force that the pelvic floor muscles can produce.
As far as investigators know, there is no study in the literature examining the relationship between BBD and pelvic angle, femoral anteversion angle, femoral internal/external rotation angle ratio and hip muscle strength ratios in children with bladder-bowel dysfunction. Considering the close relationship between pelvis position, hip muscle strength, and femoral anteversion with the pelvic floor, investigators think that this relationship should be evaluated in children with BBD and will contribute to the literature.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children diagnosed with bowel and bladder dysfunction | – | Other: Scales and measurements for bladder and bowel dysfunction, pelvic angle, proximal hip strength, femoral hip anteversionChildren who are between the ages of 5-12 and diagnosed with bladder- bowel dysfunction by pediatric urologist. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children who are between 5-12 years old, diagnosed with bladder bowel dysfunction.
Key inclusion criteria (2 listed)
- To be between the ages of 5-12
- To be diagnosed with bladder- bowel dysfunction
Key exclusion criteria (6 listed)
- To be younger than 5 years old
- To have an orthopedic disease that would prevent the evaluation
- To have anatomical changes in the urinary system
- To have having a neurological disorder
- To have cognitive impairment and mental retardation
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 |
|---|---|---|
| Scales and measurements for bladder and bowel dysfunction, pelvic angle, proximal hip strength, femoral hip anteversionAssessments Children whose physical examination has been completed and diagnosed with BBD will be evaluated with following assessments. Demographic Data Form Questionnaire Forms Dysfunctional Voiding and Incontinence Scoring System Bladder Diary Bowel Diary EMG-uroflowmetry Ultrasonography Post Voiding Residual Measurement: Bladder wall thickness Pelvic Floor Muscle Activation Measurement: Pelvic Floor Muscle Strength Assessment: Hip agonist-antagonist muscle ratios Pelvic angle measurement Femoral anteversiyon angle measurement Femoral internal and external rotation angle: | Other | Children diagnosed with bowel and bladder dysfunction |
Primary outcome
Femoral anteversion angle measurement
Time frame: Baseline
Hip anteversion was measured using the Craig test with the subject in the prone position and the knee flexed to 90°. The examiner passively rotates the hip, palpating the trochanter major, until the most prominent part of the trochanter reaches its most lateral position. The angle between the true vertical and the shaft of the tibia was measured to the nearest degree, using a Accurate Compass smartphone inclinometer.
Pelvic angle measurement
Time frame: Baseline
The inferior prominence of the anterior superior iliac spine (ASIS) and the most prominent aspect of the posterior superior iliac spine (PSIS) were identified with palpation, and pelvic angle was measured as the angle formed between the horizontal plane and a line from ASIS and PSIS landmarks using an inclinometer (Performance Attainment Associates, St Paul, MN). A positive value reflected an anterior pelvic tilt (ASIS sitting lower than the PSIS).
Hip agonist-antagonist muscle ratios
Time frame: Baseline
In the isometric muscle strength measurement procedure, each test position was evaluated with 2 repetitions of submaximal force for familiarization and 3 evaluations were taken with maximal force. Each test lasted 5 seconds, with 30-second breaks between trials. A 1-minute break was given between different measurements. MicroFET(Draper, UT) hand dynamometer was used for muscle strength measurement. The order of strength testing was randomized. The dynamometer is fixed to the leg with the help of a strap. Force values are measured in kilograms and normalized to body mass using the following formula:(kg power/kg body mass)x100. The intrarater reliability study will be completed before participants' measurements begin to be taken. Hip abductor, adductor, flexor, extensor, internal rotation, external rotation muscle strength is measured. Hip adductor/abductor, medial/lateral rotator, and flexor/extensor strength ratios muscle strength ratios will be evaluated.
6 secondary outcomes
Dysfunctional Voiding and Incontinence Scoring System
Time frame: Baseline
EMG-uroflowmetry
Time frame: Baseline
Ultrasonography - Post Voiding Residual Measurement, Bladder thickness
Time frame: Baseline
Pelvic Floor Muscle Activation Measurement:
Time frame: Baseline
Pelvic Floor Muscle Strength Assessment:
Time frame: Baseline
Femoral internal and external rotation angle
Time frame: Baseline
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 12 Feb 2024.
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.
Aygül Köseoğlu, PT, MSc principal investigator
Tuğtepe Pediatric Urology Clinic
Halil Tuğtepe, MD, Prof Dr, study chair
Tuğtepe Pediatric Urology Clinic
Pelin Pişirici, PT, PhD study director
Bahçeşehir University Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder and Bowel Dysfunction, Femoral Anteversion and Bladder and Bowel Dysfunction, Hip Strength Ratios, run by Halil Tugtepe 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 2 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 12 Feb 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?
Femoral anteversion angle measurement (time frame: Baseline). The study lists 3 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 12 Feb 2024.