Biofeedback and Osteopathic Procedures for Daytime Urinary Incontinence

NCT05957263 | Unknown DMC

• 1 other identifier: F.P.T 2307001
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urinary Incontinence

Keywords

Biofeedback training; Osteopathic procedures; 24-hour pad test; functional daytime urinary incontinence

Outcome Measures

Primary Outcomes (1)

• The 24-hour pad test

  The pad is weighed at the beginning and end of the test to determine the amount of urine leakage, which is used to estimate the severity of the condition and evaluate the effectiveness of the treatment. Several studies have been used to assess the test-retest reliability of the 24-hour pad test and found it to be a reliable tool for the diagnosis and monitoring of urinary incontinence

  10 weeks

Secondary Outcomes (2)

• Pediatric Lower Urinary Tract Symptom Score

  10 weeks

• Assessment of the frequency of daytime urinary incontinence

  10 weeks

Study Arms (3)

Biofeedback training and Osteopathy procedure

EXPERIMENTAL

the biofeedback training lasts 10 weeks and involves 3 sessions per week, with each session lasting for 15 minutes. During biofeedback-assisted pelvic floor muscle exercises, the child was asked to contract the pelvic floor muscles as if stopping peeing, after which the biofeedback device helps them understand how to better control their muscles. The osteopathy techniques involved a combination of myofascial, visceral, and articular techniques aimed at restoring and rebalancing internal tensions and improving visceral mobility.

Other: Biofeedback training and Osteopathy procedure; Other: Biofeedback training; Other: Osteopathy procedure

Biofeedback training

ACTIVE COMPARATOR

he biofeedback training lasts 10 weeks and involves 3 sessions per week, with each session lasting for 15 minutes. During biofeedback-assisted pelvic floor muscle exercises, the child was asked to contract the pelvic floor muscles as if stopping peeing, after which the biofeedback device helps them understand how to better control their muscles.

Other: Biofeedback training

Osteopathy procedure

ACTIVE COMPARATOR

The osteopathy techniques involved a combination of myofascial, visceral, and articular techniques aimed at restoring and rebalancing internal tensions and improving visceral mobility.

Other: Osteopathy procedure

Interventions

Biofeedback training and Osteopathy procedure OTHER

the biofeedback training lasts 10 weeks and involves 3 sessions per week, with each session lasting for 15 minutes. the child was asked to contract the pelvic floor muscles as if stopping peeing, after which the biofeedback device helps them understand how to better control their muscle. muscle inhibition for the psoas muscle, deep massages in the obturator foramen, stretching for the greater omentum, and abdominal maneuvers. a high velocity, low amplitude manipulation performed for the sacroiliac joint and T10-L2 region. The treatments were implemented in phases, with multiple sessions for each phase over a 10-week period. Each osteopathy session typically lasted 30 minutes, with the myofascial, visceral, and articular techniques performed twice a week for 15 minutes each session for 10 weeks, and the high velocity, l

Also known as: BTOP

Biofeedback training and Osteopathy procedure

Biofeedback training OTHER

the biofeedback training lasts 10 weeks and involves 3 sessions per week, with each session lasting for 15 minutes. During biofeedback-assisted pelvic floor muscle exercises, the child was asked to contract the pelvic floor muscles as if stopping peeing, after which the biofeedback device helps them understand how to better control their muscles.

Also known as: BIOFB

Biofeedback training; Biofeedback training and Osteopathy procedure

Osteopathy procedure OTHER

specific techniques included muscle inhibition for the psoas muscle, deep massages in the obturator foramen, stretching for the greater omentum, and abdominal maneuvers. In addition, there was a high velocity, low amplitude manipulation performed for the sacroiliac joint and T10-L2 region. The treatments were implemented in phases, with multiple sessions for each phase over a 10-week period. Each osteopathy session typically lasted 30 minutes, with the myofascial, visceral, and articular techniques performed twice a week for 15 minutes each session for 10 weeks, and the high velocity, low amplitude manipulation performed three times a week for 15 minutes each session for 10 weeks.

Also known as: OSP

Biofeedback training and Osteopathy procedure; Osteopathy procedure

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Hany Mohamed Elgohary

Cairo, 11432, Egypt

RECRUITING

Related Publications (1)

• Elgohary HM, Al Jaouni SK, Selim SA. Effect of ultrasound-enhanced Nigella sativa seeds oil on wound healing: An animal model. J Taibah Univ Med Sci. 2018 Jun 27;13(5):438-443. doi: 10.1016/j.jtumed.2018.02.008. eCollection 2018 Oct.

  PMID: 31435359 RESULT

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hany M Elgohary, PHD

CONTACT

00201093182291; gohary75pt@hotmail.com

Yossef M Elbaalawy, PHD

CONTACT

00201002776512; Youssef.mohamed@pt.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: both participants and assessors will be blind for the treatment procedures
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: controlled, double-blinded, and randomized clinical trial

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 24, 2023
• Study Start: July 20, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 20, 2023
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)