Anorectal DiseasesNCT07075692
Physiotherapy Applications in Children With Bladder and Bowel Symptoms After Anorectal Malformation Surgery
A study testing Physiotherapy in people with Anorectal Diseases, run by Ankara Yildirim Beyazıt University.
Trial summary
The aim of our study was to investigate the effects of physiotherapy applications in children with bladder and bowel symptoms after anorectal malformation surgery. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Anorectal Diseases
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2025to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged 5-18 years with bladder bowel symptoms after anorectal malformation surgery
- Volunteering to participate in the study
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of 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.
Read the detailed description
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.
- Conditions
- Anorectal Diseases
- Being tested
- Physiotherapy
- Medical subject headings
- Rectal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy group | Experimental | Physiotherapy program will be performed Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder and Bowel Dysfunction Symptoms
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.
Measured: before and after treatment (8-week change)
Secondary outcomes (7)
Bowel Function
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.
Measured: before and after treatment (8-week change)
Bladder function
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.
Measured: before and after treatment (8-week change)
Constipation
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
Measured: before and after treatment (8-week change)
Pelvic floor muscle function
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.
Measured: before and after treatment (8-week change)
Life quality
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.
Measured: before and after treatment (8-week change)
Perception of improvement
Subjective perception of improvement will be assessed as -1 (worse), 0 (no change) and 1 (better).
Measured: after treatment (8-week change)
Compliance with recommendations
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".
Measured: After treatment (8-week change)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start20 Jul 2025 (estimated)
- Primary completion20 Sep 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorectal DiseasesStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seyda toprak celenay, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075692
- Sponsor's protocol ID
- 1328
- Status last verified
- Jul 2025
- First submitted
- 11 Jul 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physiotherapy Applications in Children With Bladder and Bowel Symptoms After Anorectal Malformation Surgery
- ClinicalTrials.gov ID
- NCT07075692
- Acronym / sponsor ID
- 1328
- Conditions
- Anorectal Diseases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 20 Jul 2025 (estimated)
- Primary completion
- 20 Sep 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of our study was to investigate the effects of physiotherapy applications in children with bladder and bowel symptoms after anorectal malformation surgery.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy group | Experimental | Other: PhysiotherapyPhysiotherapy program will be performed |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children aged 5-18 years with bladder bowel symptoms after anorectal malformation surgery
- Volunteering to participate in the study
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhysiotherapyPhysiotherapy 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 | Other | Physiotherapy group |
Primary outcome
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.
7 secondary outcomes
Bowel Function
Time frame: before and after treatment (8-week change)
Bladder function
Time frame: before and after treatment (8-week change)
Constipation
Time frame: before and after treatment (8-week change)
Pelvic floor muscle function
Time frame: before and after treatment (8-week change)
Life quality
Time frame: before and after treatment (8-week change)
Perception of improvement
Time frame: after treatment (8-week change)
Compliance with recommendations
Time frame: After treatment (8-week change)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Anorectal Diseases, run by Ankara Yildirim Beyazıt University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seyda Toprak Celenay (+90 312 906 1000, sydtoprak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder and Bowel Dysfunction Symptoms (time frame: before and after treatment (8-week change)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.