NCT07075692

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 20, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

July 20, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

2 months

First QC Date

July 11, 2025

Last Update Submit

July 11, 2025

Conditions

Outcome Measures

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.

    before and after treatment (8-week change)

Secondary Outcomes (7)

  • Bowel Function

    before and after treatment (8-week change)

  • Bladder function

    before and after treatment (8-week change)

  • Constipation

    before and after treatment (8-week change)

  • Pelvic floor muscle function

    before and after treatment (8-week change)

  • Life quality

    before and after treatment (8-week change)

  • +2 more secondary outcomes

Study Arms (1)

Physiotherapy group

EXPERIMENTAL

Physiotherapy program will be performed

Other: Physiotherapy

Interventions

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

Physiotherapy group

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rectal Diseases

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Central Study Contacts

Seyda Toprak Celenay

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 11, 2025

First Posted

July 20, 2025

Study Start

July 20, 2025

Primary Completion

September 20, 2025

Study Completion

December 20, 2025

Last Updated

July 20, 2025

Record last verified: 2025-07