Biofeedback and Osteopathic Procedures for Daytime Urinary Incontinence

Last updated: July 14, 2023
Sponsor: Cairo University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urinary Incontinence

Enuresis

Treatment

Osteopathy procedure

Biofeedback training and Osteopathy procedure

Biofeedback training

Clinical Study ID

NCT05957263
F.P.T 2307001
  • Ages 6-16
  • All Genders

Study Summary

The study will enroll 113 participants, randomly will be assigned to one of three groups will receive either group A will receive combined therapy of biofeedback training and osteopathy techniques, group B will receive biofeedback training, group C will receive osteopathy technique only over a period of 10 weeks, followed by an 8-week follow-up period. Outcome measures will include the 24-hour pad test, Pediatric Lower Urinary Tract Symptom Score (PLUTSS), and the bladder diary.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • between 6 and 16 years old
  • have functional daytime urinary incontinence for at least six months
  • at least three episodes per week

Exclusion

Exclusion Criteria:

  • neurological disorders,
  • previous operations on the urinary or bowel system
  • current use of certain medications that could interfere with study results
  • pose a risk to the participant's health
  • severe cognitive impairment or dementia

Study Design

Total Participants: 117
Treatment Group(s): 3
Primary Treatment: Osteopathy procedure
Phase:
Study Start date:
July 20, 2023
Estimated Completion Date:
December 20, 2023

Study Description

Children (male and female) with functional daytime urinary incontinence, typically the urge type, who were referred for physical therapy by a urologist were recruited from Mansoura Urology and Nephrology Hospital at Mansoura University. To participate in the study, participants had to be between 6 and 16 years old and have had functional daytime urinary incontinence for at least six months, with at least three episodes per week and a total of at least 60 ml of urine loss per week. Certain exclusion criteria were applied, including not having other types of urinary incontinence, neurological disorders, previous operations on the urinary or bowel system, current use of certain medications that could interfere with study results or pose a risk to the participant's health, severe cognitive impairment or dementia, recent participation in another clinical trial, active urinary tract infection (UTI), not having vascular disorders in the urinary system, and parental refusal to sign the written consent form.

Connect with a study center

  • Hany Mohamed Elgohary

    Cairo, 11432
    Egypt

    Active - Recruiting

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