Standard Urotherapy With or Without Biofeedback-Based Pel... | NCT07149532

Studies
Standard Urotherapy With or Without Biofeedback-Based Pelvic Floor Muscle Training for Dysfunctional Voiding in Children

NCT07149532

Sponsor

Tanta University

Status

Recruiting

Last Update Posted

Mar 5, 2026Actual

Enrollment

124Estimated

Phase

Not Applicable

Conditions

Biofeedback
Medical Treatment
Dysfunctional Voiding
Children

Interventions

Biofeedback-based pelvic floor muscle training
Biofeedback-based pelvic floor muscle training (PFMT) with medical treatment

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 26, 2025Actual

Primary Completion Date

Apr 1, 2026Estimated

Completion Date

Apr 1, 2026Estimated

First Submitted Date

Aug 24, 2025

First Submission Date that Met QC Criteria

Aug 24, 2025

First Posted Date

Sep 2, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2026

Last Update Posted Date

Mar 5, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohamed Ibrahim Ahmed Elmaadawy, Lecturer of Urology, Faculty of Medicine, Tanta University, Tanta, Egypt., Tanta UniversityPrincipal Investigator

Lead Sponsor

Tanta UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to compare the efficiency of biofeedback therapy alone versus biofeedback therapy with medical treatment for dysfunctional voiding in children.

Detailed Description

Dysfunctional voiding (DV) in children may result in lower urinary tract symptoms (LUTS), such as urgency, frequency, urinary incontinence, and difficulty in urination.

Noninvasive assessments and biofeedback-based pelvic floor muscle training (PFMT) can effectively improve LUTS and protect upper urinary tract function in children, in addition to medical treatment.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

124Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Active Comparator	Patients will receive the biofeedback-based pelvic floor muscle training (PFMT) alone.	Other: Biofeedback-based pelvic floor muscle training
Group 2	Experimental	Patients will receive the biofeedback-based pelvic floor muscle training (PFMT) with medical treatment.	Other: Biofeedback-based pelvic floor muscle training (PFMT) with medical treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biofeedback-based pelvic floor muscle training	Other	Patients will receive the biofeedback-based pelvic floor muscle training (PFMT) alone.	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall response rate	Overall response rate will be recorded.	6 months post-procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children less than 18 years old.
Both sexes.
Children with dysfunctional voiding.

Exclusion Criteria:

Patients with cognitive function impairment.
Patients who received any care for dysfunctional voiding.
Children with known anatomical anomalies of the urinary tract.
Children with known neurological anomalies (spinal dysraphism, multiple sclerosis, lumbar or spinal neuritis……… etc).
Children with a history of back or lower urinary tract trauma.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohamed I Elmaadawy, MD	Contact	00201060245430		Mohamed.elmaadawy@med.tanta.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tanta University	Recruiting	Tanta	El-Gharbia	31527	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Types

Study Protocol

Time Frame

After the end of study for one year.

Access Criteria

The data will be available upon a reasonable request from the corresponding author.

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.