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Not yet recruitingNCT07075692Updated Jul 20, 2025

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

An interventional study of Physiotherapy in Anorectal Diseases, sponsored by Ankara Yildirim Beyazıt University. Not yet recruiting. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-07-20.

Sponsored by Ankara Yildirim Beyazıt University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
5 Years to 18 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Anorectal Diseases

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03

In context

Rectal Diseases

87 studies on the registry are indexed under Rectal Diseases; 14 are open to participants now.

This study's planned enrollment of 20 is below the median of 114 across 59 interventional studies indexed under Rectal Diseases.

Browse Rectal Diseases studies →

Lead sponsor

Ankara Yildirim Beyazıt University is the lead sponsor of 241 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Physiotherapy group

    Physiotherapy program will be performed

    Other: Physiotherapy

Interventions

  • OtherPhysiotherapy

    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

06

What researchers measure

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. 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.

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

  2. 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.

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

  3. 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

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

  4. 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.

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

  5. 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.

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

  6. Perception of improvement

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

    Time frame: after treatment (8-week change)

  7. 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".

    Time frame: After treatment (8-week change)

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2025; primary completion for Sep 2025, 2 months later.

Of 16 interventional studies with no phase under Rectal Diseases, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 57. This study's planned 2 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 11, 2025
First posted
Jul 20, 2025
StartEst.
Jul 20, 2025
Primary completionEst.
Sep 20, 2025
CompletionEst.
Dec 20, 2025
Last update
Jul 20, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07075692
Responsible party
seyda toprak celenay (Professor, Ankara Yildirim Beyazıt University) — Principal investigator
First posted
Jul 20, 2025
Start date
Jul 20, 2025 (estimated)
Primary completion
Sep 20, 2025 (estimated)
Completion
Dec 20, 2025 (estimated)
Last update
Jul 20, 2025

Study contacts

Seyda Toprak Celenay
Contact
sydtoprak@hotmail.com
+90 312 906 1000

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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