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NCT Number: NCT07075692

Physiotherapy Applications in Children With Bladder and Bowel Symptoms After Anorectal Malformation Surgery

The aim of our study was to investigate the effects of physiotherapy applications in children with bladder and bowel symptoms after anorectal malformation surgery.

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Key information

Conditions

Anorectal Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Anorectal malformation (ARM) is a congenital anomaly in which the rectum and anus of the developing fetus fail to form normally before birth. The main treatment for ARM is surgery. However, various complications may occur in these children after surgery due to disruption of the muscular structure, nerve damage and weakness of the sphincters. These complications include fecal incontinence, chronic constipation, difficulty in defecation and abdominal pain. Constipation and fecal incontinence can be seen quite frequently in these individuals. Sometimes these symptoms may be accompanied by additional bladder problems (urinary incontinence etc.). Bowel training, dietary recommendations, toilet training, enemas, medications and physiotherapy applications can be used in the management of fecal incontinence and constipation. In the literature, there are limited number of studies evaluating physiotherapy applications in the management of postoperative bladder bowel symptoms in children with ARM.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children aged 5-18 years with bladder bowel symptoms after anorectal malformation surgery
  • Volunteering to participate in the study

Exclusion criteria

  • Presence of a congenital and/or chronic disease
  • Having a history of any additional neurological, orthopedic or psychiatric disease that will affect the evaluation parameters
  • Mental retardation
  • Having received physiotherapy within the last 1 year

Treatment and study plan

Physiotherapy

Other

Physiotherapy program will include patient education, lifestyle recommendations (fluid intake, diet, correct urination/defecation position, weight control, etc.), breathing exercises, pelvic floor muscle training, and stabilization exercises. The treatment program will last for a total of 8 weeks

Primary outcomes

  1. Bladder and Bowel Dysfunction Symptoms

    Time frame: before and after treatment (8-week change)

    Bladder and bowel symptoms will be assessed with the Bladder and Bowel Dysfunction Score. The scale consists of 14 questions. The total score ranges from 0-52 and an increase in score means an increase in symptom severity.

Secondary outcomes

  1. Bowel Function

    Time frame: before and after treatment (8-week change)

    Bowel function will be evaluated with a bowel diary. They will be asked to keep a bowel diary for 1 week, including the number and type of daily stools and the number of incontinent stools.

  2. Bladder function

    Time frame: before and after treatment (8-week change)

    Bladder function will be evaluated with bladder diaries including voiding frequency, voiding volüme and number of incontinence In the bladder diary, they will be asked to fill in a 3-day bladder diary.

  3. Constipation

    Time frame: before and after treatment (8-week change)

    Children's constipation will be evaluated with the Rome IV criteria. These criteria include; two or less defecation per week, fecal incontinence at least once a week, history of holding/ delaying the large toilet, painful and difficult bowel movements, presence of large feces in the rectum, presence of a history of large feces that can block the toilet

  4. Pelvic floor muscle function

    Time frame: before and after treatment (8-week change)

    Pelvic floor muscle function will be evaluated with palpation form anus. The presence of correct contraction and relaxation of the pelvic floor muscle will be determined.

  5. Life quality

    Time frame: before and after treatment (8-week change)

    Quality of life will be assessed with the Pediatric Quality of Life Inventory (PedsQL). The PedsQL consists of 23 items. It are scored between 0-100. The higher the total score of the quality of life, the better health-related quality of life is perceived.

  6. Perception of improvement

    Time frame: after treatment (8-week change)

    Subjective perception of improvement will be assessed as -1 (worse), 0 (no change) and 1 (better).

  7. Compliance with recommendations

    Time frame: After treatment (8-week change)

    Compliance with post-treatment recommendations will be assessed with the Visual Analog Scale (VAS). The VAS is a horizontal line with "0" at one end as "never compliance" and '10' at the other end as "always compliance".

Study contacts

Contact information is provided by the study sponsor or research team.

Seyda Toprak Celenay

CONTACT

[email protected]

+90 312 906 1000

Sponsors and collaborators

Lead sponsor

Ankara Yildirim Beyazıt University

Other

Registry information

Official study title

Effects of Physiotherapy Applications in Children With Bladder and Bowel Symptoms After Anorectal Malformation Surgery

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 20, 2025
Registry last updated
Jul 20, 2025

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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