Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202306754593717 Date of Approval: 15/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Urodynamic impact of pulsed electromagnetic field therapy (PEMFT) on the neurogenic overactive bladder after partial spinal cord injury: a randomized controlled study
Official scientific title Urodynamic impact of pulsed electromagnetic field therapy (PEMFT) on the neurogenic overactive bladder after partial spinal cord injury: a randomized controlled study
Brief summary describing the background and objectives of the trial Individuals with Overactive Bladder Syndrome (OAB) have symptoms such as urine urgency, excessive urinary frequency, or urge incontinence. These symptoms are not dangerous, but they might cause embarrassment. The most troublesome symptom is incontinence. The consequence of spinal cord transaction (for example, in a paraplegic patient) involves the first stage of spinal cord shock, in which the bladder gets overfilled and intermittent voiding occurs (overflow incontinence). The voiding reflex gradually returns, but there is no purposeful contraction. Bladder capacity is frequently decreased, and reflex hyperactivity may result in a condition known as spastic neurogenic bladder. The bladder cannot empty, resulting in leftover urine. The term "neurogenic bladder" refers to bladder dysfunction caused by injury or illness to the central nervous system (CNS) , As a result, it is a broad diagnosis that includes any neurological damage to the CNS that causes bladder dysfunction. Neurogenic bladder dysfunction is present in all people who have had a spinal cord injury (SCI), who have chronic neurological impairments, as well as in 70% of ambulatory SCI patients. Bladder dysfunction is common in spina bifida, which affects around one out of every 1000 live babies. Magnetic field stimulation (MFS) is a revolutionary non-invasive approach for stimulating the nervous system that may stimulate deep brain regions via generated electric currents without causing pain or discomfort. Furthermore, MFS of the pelvic floor and sacral roots has been demonstrated in numerous clinical trials, including placebo-controlled ones, to be helpful for overactive bladder (OAB). MFS similarly suppresses detrusor overactivity as electrical stimulation, but with far greater therapeutic effects. MFS of the sacral nerve roots has the potential to be a successful OAB alternative treatment. Aim: This study was applied to evaluate the urodynamic effect of pulsed electromagnetic field therapy (PEMFT) in the neurogenic overactive bladder following partial spinal cord injury
Type of trial RCT
Acronym (If the trial has an acronym then please provide) repeated evaluation
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 03/11/2022
Actual trial start date 22/12/2022
Anticipated date of last follow up 12/08/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Central randomisation by phone/fax Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group pulsed electromagnetic field therapy the low-frequency pulsed electromagnetic field (15 Hz, 50% intensity output for 5 s/min for 20 minutes) and pelvic floor muscle training 3 times/ week for 6 weeks, 6 weeks • low-frequency PEMFT: A magnetotherapy device was used for the PEMFT (PMT Qs; ASALASER, Arcugnano, VI, Italy (15 Hz, 50% intensity output for 5 s/min for 20 min) three times each week for 18 sessions. The patients were placed in a prone posture for repeated stimulation of the sacral roots and pelvic floor muscle exercises, and this group was also treated with pelvic floor muscle exercises for 15 minutes three times per week for 18 sessions. • pelvic floor muscle training(three times each week for 18 sessions)Aim to be able to do 10 long squeezes, holding each squeeze for 10 seconds, followed by 10 short squeezesas follows: [10] 1- long squeezes: - • tighten your pelvic floor muscles, hold them tight, then release and let them fully relax. • record the time patient can hold the contraction. • repeat the squeeze and hold until the pelvic floor muscle tire and record the times of repetition. 2- Short squeeze: • Quickly tighten your pelvic floor muscles, then immediately let them go again. • Record times of repetitions. • Always let the muscles fully relax after each squeeze. 20
Control Group pelvic floor exercises pelvic floor muscle training 3 times/ week for 6 weeks. 6 weeks • pelvic floor muscle training(three times each week for 18 sessions)Aim to be able to do 10 long squeezes, holding each squeeze for 10 seconds, followed by 10 short squeezesas follows: [10] 1- long squeezes: - • tighten your pelvic floor muscles, hold them tight, then release and let them fully relax. • record the time patient can hold the contraction. • repeat the squeeze and hold until the pelvic floor muscle tire and record the times of repetition. 2- Short squeeze: • Quickly tighten your pelvic floor muscles, then immediately let them go again. • Record times of repetitions. • Always let the muscles fully relax after each squeeze. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
neurogenic overactive bladder due to a partial lesion of the spinal cord above T12 from more than 6 months based on both clinical assessment and radiological investigations of the spine including Computed Tomography (C.T scan) and/or Magnetic Resonance Imaging (MRI) 1) overactive bladder due to other neurological disorders as sensory manifestations of the bladder in polyneuropathic and diabetic patients 2) a history of bladder trauma or surgery as fracture pelvis, orthopedic disorders of the pelvis as a chronic pelvic syndrome 3) Spinal cord lesion below T12 and overactive bladder associated with stress urinary incontinence (mixed incontinence) 4) Patients with partial spinal cord lesions above T12 and overactive bladder and take medication were excluded from the study. Adult: 19 Year-44 Year 20 Year(s) 40 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/12/2022 research ethics review committee
Ethics Committee Address
Street address City Postal code Country
faculty of physical therapy south valley university Qena 83523 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Urodynamic and flowmetry test: • Urodynamic Dantic 5000/5500. The urodynamic investigation system and voiding cytometry were used to carry out the urodynamic examination. • The urodynamic machine is a trolley-mounted equipment with an integrated printer and display. • A transportable patient unit that includes built-in H2O and CO2 pumps, a standard-mounted uroflow transducer, and a standard-mounted puller mechanism. pre an post 6 weks of treatrment
Secondary Outcome Revised Urinary Incontinence Scale (RUIS). • The revised urinary incontinence scale includes both questions from the incontinence severity index. The revised urinary incontinence scale is a valid and reliable scale used to assess the severity of incontinence pre and post 6 weeks of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
physical therapy and rehablitation center faculty of physical therapy south valley university south valley university Qena 83523 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self south valley university Qena Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor south valley university south valley university Qena 83523 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmoud Elshazly mahmoud.elshazly311@svu.edu.eg 001019833732 south valley university
City Postal code Country Position/Affiliation
Qena 83523 Egypt assisstance professor of physical therapy for surgery
Role Name Email Phone Street address
Scientific Enquiries abdelrzak ahmed dr_abdelrzak_pt@yahoo.com 001063267068 south valley university
City Postal code Country Position/Affiliation
Qena 83523 Egypt lectutrer of physical therapy for neurolgical disease
Role Name Email Phone Street address
Public Enquiries sallam ali sallam sallampt@svu.edu.eg 001000693632 south valley university
City Postal code Country Position/Affiliation
Qena 83523 Egypt lecturer of physical therapy baisc science department
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Study Protocol Beginning 9 months and ending 36 months following article publication. Investigators whose proposed use of the data has been approved by and independent review committee (“learned intermediary”) identified for this purpose.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information