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Completed

NCT Number: NCT05824429

Connective Tissue Manipulation on Pelvic Floor Muscle Functions in Children

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.

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Key information

Conditions

Lower Urinary Tract Symptoms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yeditepe University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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

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.

Primary outcomes

  1. EMG- Uroflowmetry

    Time frame: 8 weeks

    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.

  2. Pelvic Floor Muscle Activation Assestment

    Time frame: 8 weeks

    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.

  3. Bladder Diary

    Time frame: 8 weeks

    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

  4. Dysfunctional Voiding and Incontinence Scoring System (DVISS)

    Time frame: 8 weeks

    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.

  5. Clinical Symtoms Information Form

    Time frame: 8 weeks

    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 outcomes

  1. Post-Voiding Residue (PVR)

    Time frame: 8 weeks

    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.

  2. Pediatric Incontinance Questionnaire (PinQ)

    Time frame: 8 weeks

    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.

  3. Connective Tissue Evaluation

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Yeditepe University

Other

Collaborators

  • Tugtepe Pediatric Urology Clinic

Registry information

Official study title

Effects of Connective Tissue Manipulation on Clinical Symptoms and Pelvic Floor Muscle Functions in Children With Lower Urinary Tract Dysfunction

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 21, 2023
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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