Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of EMS and TENS in Patients With Overactive Bladder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04364438
Recruitment Status : Recruiting
First Posted : April 28, 2020
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Sajid rashid, Isra University

Brief Summary:
Overactive bladder (OAB) syndrome is a well-recognized set of symptoms which patient experience during the storage phase of the micturition cycle. It is characterized by urgency (a sudden compelling desire to pass urine which is difficult to defer) which, in almost all patients, is accompanied by increased frequency and nocturia and, particularly in female patients, by urgency incontinence.

Condition or disease Intervention/treatment Phase
Overactive Bladder Device: Electric Muscle Stimulation Device: Transcutaneous Electric Nerve Stimulation Not Applicable

Detailed Description:

Leaking urine is called "incontinence". Stress urinary incontinence (SUI), is another common bladder problem. It's different from OAB. People with SUI leak urine while sneezing, laughing or doing other physical activities. If you have an overactive bladder, you may feel embarrassed, isolate yourself, or limit your work and social life.

Overactive bladder (OAB) is a very common clinical condition, with an overall prevalence estimated at 11.5% in the general population of Pakistan.

In traditional medicine and recent years, nerve stimulation has been introduced as a replacement therapy for managing several disorders such as overactive bladder. However, there is still controversy in this regard. Therefore, the present study is aimed to find out the effectiveness of Electric Muscle Stimulation and Transcutaneous Electric Nerve Stimulation in treatment of overactive bladder.To overcome this controversy we need to do this study in Pakistan and find out whether there is any role of EMS and TENS in the management of OAB.

OAB is one of the important conditions that lead to the limitation in activity and participation due to dribbling, urgency and frequency of urination. According to literature review there is a strong linkage between OAB rehabilitation and improvement of patient symptoms. The Neuromodulation plays a significant role in the management of OAB. The proper task specific rehabilitation not only improves the functional status of a person rather it enhances the quality of life and their active role in community. In routine rehabilitation main focus is always on the role of pelvic floor exercises but Neuromodulation is still neglected in treatment regimen of OAB in Pakistan. The patients will profit in better help of manifestations if Neuromodulation intervention is applied that is upheld by proof for the treatment of OAB. The consequences of the investigation will be useful for the Physical Therapists in planning and picking best treatment approach for the treatment of OAB.

TENS is based on the gate control theory of abolishing the local micturition reflex arc. It is a non-pharmacological method of inhibiting the presynaptic afferent neurons carrying impulses from bladder by stimulating the nerves of peripheral segmental dermatome (gate control theory of electro modulation by stimulating the peripheral nerves corresponding to the visceral organ). It acts at the level of primitive voiding reflex coordinating the bladder, sphincter and the pelvic floor. Detrusor hyperreflexia can be inhibited by direct inhibition of impulses in the preganglionic afferent neuron or by inhibition of bladder preganglionic neurons of the efferent limb of micturition reflex.

EMS is also believed to produce some inhibition of the bladder, allowing the bladder to reach a greater volume. This is believed to occur because electrical stimulation also stimulates nerves in the pelvic floor. In most people, bladder voiding is inhibited when the skin of the pelvis is touched or otherwise manipulated. This inhibition is via a reflex in the spinal cord that may have evolved to inhibit voiding during sexual contact. The pelvic floor nerves are responsible for transmitting the sensation of touch from the pelvis to the spinal cord. Electrical stimulation of these nerves thus activates sensory fibers that cause inhibition of bladder voiding via a reflex mechanism in the spinal cord. This may explain EMS is an effective treatment for people with incontinence.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 315 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The total sample will be divided into three groups i.e., Control group and two experimental groups. Control group will be treated with conventional medical treatment including anticholinergics and pelvic floor muscle exercises while 1st experimental group will be treated with conventional treatment and EMS and the 2nd experimental group will be treated with conventional treatment and TENS.

initial results will be measured by Overactive Bladder Scoring System and King's Health Questionnaire. A follow up chart will be maintained after every 03 weeks regarding the symptoms of the patients and Quality of Life. After 12 weeks( completion of treatment) the patient will be re evaluated for their symptoms and graded by using Overactive Bladder Scoring System and King's Health Questionnaire.

A comparison will be made among data obtained from 03 groups to check the effectiveness of intervention by using statistical analysis

Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial on Effectiveness of Electric Muscle Stimulation (EMS) and Transcutaneous Electric Nerve Stimulation (TENS) in Patients With Overactive Bladder
Actual Study Start Date : March 3, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control Group
Patients will be treated with conventional medical treatment for overactive bladder including anticholinergic drugs and pelvic floor muscle exercises
Experimental: EMS Group
Patients will be treated with conventional medical treatment for overactive bladder including anticholinergic drugs and pelvic floor muscle exercises along with Electric Muscle Stimulation (EMS)
Device: Electric Muscle Stimulation
EMS is believed to produce some inhibition of the bladder, allowing the bladder to reach a greater volume. This is believed to occur because electrical stimulation also stimulates nerves in the pelvic floor. In most people, bladder voiding is inhibited when the skin of the pelvis is touched or otherwise manipulated. This inhibition is via a reflex in the spinal cord that may have evolved to inhibit voiding during sexual contact. The pelvic floor nerves are responsible for transmitting the sensation of touch from the pelvis to the spinal cord. Electrical stimulation of these nerves thus activates sensory fibers that cause inhibition of bladder voiding via a reflex mechanism in the spinal cord. This may explain EMS is an effective treatment for people with incontinence.
Other Name: EMS

Experimental: TENS Group
Patients will be treated with conventional medical treatment for overactive bladder including anticholinergic drugs and pelvic floor muscle exercises along with Transcutaneous Electric Nerve Stimulation (TENS)
Device: Transcutaneous Electric Nerve Stimulation
TENS is based on the gate control theory of abolishing the local micturition reflex arc. It is a non-pharmacological method of inhibiting the presynaptic afferent neurons carrying impulses from bladder by stimulating the nerves of peripheral segmental dermatome (gate control theory of electro modulation by stimulating the peripheral nerves corresponding to the visceral organ). It acts at the level of primitive voiding reflex coordinating the bladder, sphincter and the pelvic floor. Detrusor hyperreflexia can be inhibited by direct inhibition of impulses in the preganglionic afferent neuron or by inhibition of bladder preganglionic neurons of the efferent limb of micturition reflex.
Other Name: TENS




Primary Outcome Measures :
  1. Overactive Bladder Scoring System (Change is being assessed) [ Time Frame: Baseline and week 12 ]
    The Overactive Bladder Scoring System is a symptom assessment questionnaire designed to quantify OAB symptoms into a single score. The questionnaire consists of 4 questions on OAB symptoms with maximum scores ranging from 2 to 5: daytime frequency (2 points), night-time frequency (3 points), urgency (5 points), and UUI (5 points). The total score ranges from 0 to 15 points, with higher scores indicating higher symptom severity. Initial results will be measured by using overactive bladder scoring system. After 12 weeks ( Completion of Treatment) patients will be re evaluated for their symptoms and graded again by using overactive bladder scoring system. A comparison will be made among data obtained from 03 groups to check the effectiveness of intervention


Secondary Outcome Measures :
  1. King's Health Questionnaire (Change is being assessed) [ Time Frame: Baseline and week 12 ]
    The King's Health Questionnaire (KHQ) is a disease-specific health-related quality-of-life (HRQoL) instrument to measure HRQoL of patients with urinary incontinence. Since its development the KHQ has been widely used in clinical studies as a valid, reliable and clinically sensitive endpoint. The individual items in the domains are scaled from 0 ( Best) to 100 ( Worst).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Both Male and Female patients ≥35years to 60 years with OAB symptoms of urgency, frequency, nocturia and urgency urinary incontinence (UUI).8
  • Those who have symptoms of urinary frequency and urgency lasting more than 3 months.
  • Those who have an average urinary frequency of more than eight times per day and urgency defined by the urgency rating scale (URS) on the bladder diary of more than 2 points. 9

Exclusion Criteria:

  • Diagnosed with Urinary Tract Infection by urine examination.
  • Stress urinary incontinence without symptoms of OAB.
  • History of cystocele, uterine prolapse or similar condition.
  • History of obstructive uropathy such as urinary stones and urinary tumors.
  • Prostate
  • Malignancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04364438


Contacts
Layout table for location contacts
Contact: Sajid Rashid, M.Phil 00923006309825 sajidch71@hotmail.com
Contact: Rehan Khan, M.Phil 00923343074756 rehan99physio@gmail.com

Locations
Layout table for location information
Pakistan
Sajid Rashid Recruiting
Multān, Punjab, Pakistan, 60000
Contact: Sajid Rashid, M.Phil    00923006309825    sajidch71@hotmail.com   
Principal Investigator: Sajid Rashid, M.Phil         
Sponsors and Collaborators
Isra University
Investigators
Layout table for investigator information
Study Chair: Naveed Babur, Ph.D Isra University, Islamabad
Additional Information:
Publications:

Layout table for additonal information
Responsible Party: Sajid rashid, Principal Investigator, Isra University
ClinicalTrials.gov Identifier: NCT04364438    
Other Study ID Numbers: 1502-PhD-007
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sajid rashid, Isra University:
Urinary Bladder, Overactive
Urinary Incontinence
Quality of Life
Transcutaneous Electric Nerve Stimulation
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations