Clinical trial NCT05824429: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lower Urinary Tract Symptoms
Keywords: Pelvic Floor
Urinary Incontinence
Connective Tissue
Lead sponsor: Yeditepe University
Sponsor class: OTHER
Collaborators: name: Tugtepe Pediatric Urology Clinic
First posted: 2023-04-21
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: EMG- Uroflowmetry
timeFrame: 8 weeks
measure: Pelvic Floor Muscle Activation Assestment
timeFrame: 8 weeks
measure: Bladder Diary
timeFrame: 8 weeks
measure: Dysfunctional Voiding and Incontinence Scoring System (DVISS)
timeFrame: 8 weeks
measure: Clinical Symtoms Information Form
timeFrame: 8 weeks
Secondary outcomes:
measure: Post-Voiding Residue (PVR)
timeFrame: 8 weeks
measure: Pediatric Incontinance Questionnaire (PinQ)
timeFrame: 8 weeks
measure: Connective Tissue Evaluation
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yeditepe University
Study officials:
affiliation: Tugtepe Pediatric Urology Center
name: Halil Tuğtepe, Prof Dr
role: STUDY_CHAIR
affiliation: Tugtepe Pediatric Urology Center
name: Melis Ünal, PT
role: STUDY_DIRECTOR
References: