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Connective Tissue Manipulation on Pelvic Floor Muscle Functions in Children

Primary Purpose

Lower Urinary Tract Symptoms

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Urotherapy
Diaphragmatic Breathing Exercises
PFM Exercises
Connective Tissue Manipulation
Sponsored by
Yeditepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Urinary Tract Symptoms focused on measuring Pelvic Floor, Urinary Incontinence, Connective Tissue

Eligibility Criteria

5 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Yeditepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Connective Tissue Manipulation Group

Control Group

Arm Description

Urotheraphy Diaphragmatic Breathing Exercises Pelvic Floor Muscle Exercise Connective Tissue Manipülation

Urotheraphy Diaphragmatic Breathing Exercises Pelvic Floor Muscle Exercise

Outcomes

Primary Outcome Measures

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.
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.
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
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 5, 2023
Last Updated
April 19, 2023
Sponsor
Yeditepe University
Collaborators
Tugtepe Pediatric Urology Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05824429
Brief Title
Connective Tissue Manipulation on Pelvic Floor Muscle Functions in Children
Official Title
Effects of Connective Tissue Manipulation on Clinical Symptoms and Pelvic Floor Muscle Functions in Children With Lower Urinary Tract Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 5, 2023 (Anticipated)
Primary Completion Date
July 5, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeditepe University
Collaborators
Tugtepe Pediatric Urology Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms
Keywords
Pelvic Floor, Urinary Incontinence, Connective Tissue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Connective Tissue Manipulation Group
Arm Type
Experimental
Arm Description
Urotheraphy Diaphragmatic Breathing Exercises Pelvic Floor Muscle Exercise Connective Tissue Manipülation
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Urotheraphy Diaphragmatic Breathing Exercises Pelvic Floor Muscle Exercise
Intervention Type
Other
Intervention Name(s)
Urotherapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Diaphragmatic Breathing Exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
PFM Exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Connective Tissue Manipulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
EMG- Uroflowmetry
Description
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.
Time Frame
8 weeks
Title
Pelvic Floor Muscle Activation Assestment
Description
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.
Time Frame
8 weeks
Title
Bladder Diary
Description
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
Time Frame
8 weeks
Title
Dysfunctional Voiding and Incontinence Scoring System (DVISS)
Description
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.
Time Frame
8 weeks
Title
Clinical Symtoms Information Form
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Post-Voiding Residue (PVR)
Description
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.
Time Frame
8 weeks
Title
Pediatric Incontinance Questionnaire (PinQ)
Description
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.
Time Frame
8 weeks
Title
Connective Tissue Evaluation
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Halil Tuğtepe, Prof Dr
Organizational Affiliation
Tugtepe Pediatric Urology Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Melis Ünal, PT
Organizational Affiliation
Tugtepe Pediatric Urology Center
Official's Role
Study Director
Facility Information:
Facility Name
Yeditepe University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Connective Tissue Manipulation on Pelvic Floor Muscle Functions in Children

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