Connective Tissue Manipulation on Pelvic Floor Muscle Functions in Children

NCT05824429 | Completed

• 1 other identifier: MelisU
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Urinary Tract Symptoms

Keywords

Pelvic Floor; Urinary Incontinence; Connective Tissue

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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

  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.

  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.

  8 weeks

Secondary Outcomes (3)

• Post-Voiding Residue (PVR)

  8 weeks

• Pediatric Incontinance Questionnaire (PinQ)

  8 weeks

• Connective Tissue Evaluation

  8 weeks

Study Arms (2)

Connective Tissue Manipulation Group

EXPERIMENTAL

Urotheraphy Diaphragmatic Breathing Exercises Pelvic Floor Muscle Exercise Connective Tissue Manipülation

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

Other: Urotherapy; Other: Diaphragmatic Breathing Exercises; Other: PFM Exercises

Interventions

Urotherapy OTHER

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.

Connective Tissue Manipulation Group; Control Group

Diaphragmatic Breathing Exercises OTHER

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.

Connective Tissue Manipulation Group; Control Group

PFM Exercises OTHER

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 Manipulation Group; Control Group

Connective Tissue Manipulation OTHER

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.

Connective Tissue Manipulation Group

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yeditepe University: lead
• Tugtepe Pediatric Urology Clinic: collaborator

Study Sites (1)

Yeditepe University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Urinary Incontinence

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Halil Tuğtepe, Prof Dr

  Tugtepe Pediatric Urology Center

  STUDY CHAIR

• Melis Ünal, PT

  Tugtepe Pediatric Urology Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 21, 2023
• Study Start: May 5, 2023
• Primary Completion: July 5, 2023
• Study Completion: August 1, 2023
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)