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Effectiveness of EMS and TENS in Patients With Overactive Bladder

Primary Purpose

Overactive Bladder

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Electric Muscle Stimulation
Transcutaneous Electric Nerve Stimulation
Sponsored by
Isra University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Urinary Bladder, Overactive, Urinary Incontinence, Quality of Life, Transcutaneous Electric Nerve Stimulation

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sajid RashidRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control Group

EMS Group

TENS Group

Arm Description

Patients will be treated with conventional medical treatment for overactive bladder including anticholinergic drugs and pelvic floor muscle exercises

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)

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)

Outcomes

Primary Outcome Measures

Overactive Bladder Scoring System (Change is being assessed)
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

King's Health Questionnaire (Change is being assessed)
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).

Full Information

First Posted
April 23, 2020
Last Updated
April 25, 2020
Sponsor
Isra University
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1. Study Identification

Unique Protocol Identification Number
NCT04364438
Brief Title
Effectiveness of EMS and TENS in Patients With Overactive Bladder
Official Title
A Randomized Controlled Trial on Effectiveness of Electric Muscle Stimulation (EMS) and Transcutaneous Electric Nerve Stimulation (TENS) in Patients With Overactive Bladder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 3, 2020 (Actual)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isra University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Urinary Bladder, Overactive, Urinary Incontinence, Quality of Life, Transcutaneous Electric Nerve Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
315 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients will be treated with conventional medical treatment for overactive bladder including anticholinergic drugs and pelvic floor muscle exercises
Arm Title
EMS Group
Arm Type
Experimental
Arm Description
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)
Arm Title
TENS Group
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Electric Muscle Stimulation
Other Intervention Name(s)
EMS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Transcutaneous Electric Nerve Stimulation
Other Intervention Name(s)
TENS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overactive Bladder Scoring System (Change is being assessed)
Description
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
Time Frame
Baseline and week 12
Secondary Outcome Measure Information:
Title
King's Health Questionnaire (Change is being assessed)
Description
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).
Time Frame
Baseline and week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sajid Rashid, M.Phil
Phone
00923006309825
Email
sajidch71@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rehan Khan, M.Phil
Phone
00923343074756
Email
rehan99physio@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naveed Babur, Ph.D
Organizational Affiliation
Isra University, Islamabad
Official's Role
Study Chair
Facility Information:
Facility Name
Sajid Rashid
City
Multān
State/Province
Punjab
ZIP/Postal Code
60000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sajid Rashid, M.Phil
Phone
00923006309825
Email
sajidch71@hotmail.com
First Name & Middle Initial & Last Name & Degree
Sajid Rashid, M.Phil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19913821
Citation
MacDiarmid SA, Peters KM, Shobeiri SA, Wooldridge LS, Rovner ES, Leong FC, Siegel SW, Tate SB, Feagins BA. Long-term durability of percutaneous tibial nerve stimulation for the treatment of overactive bladder. J Urol. 2010 Jan;183(1):234-40. doi: 10.1016/j.juro.2009.08.160.
Results Reference
background
PubMed Identifier
26073262
Citation
Preyer O, Umek W, Laml T, Bjelic-Radisic V, Gabriel B, Mittlboeck M, Hanzal E. Percutaneous tibial nerve stimulation versus tolterodine for overactive bladder in women: a randomised controlled trial. Eur J Obstet Gynecol Reprod Biol. 2015 Aug;191:51-6. doi: 10.1016/j.ejogrb.2015.05.014. Epub 2015 Jun 3.
Results Reference
background
PubMed Identifier
23240797
Citation
Jokhio AH, Rizvi RM, Rizvi J, MacArthur C. Urinary incontinence in women in rural Pakistan: prevalence, severity, associated factors and impact on life. BJOG. 2013 Jan;120(2):180-186. doi: 10.1111/1471-0528.12074.
Results Reference
background
PubMed Identifier
27891403
Citation
Sharma N, Rekha K, Srinivasan KJ. Efficacy of Transcutaneous Electrical Nerve Stimulation in the Treatment of Overactive Bladder. J Clin Diagn Res. 2016 Oct;10(10):QC17-QC20. doi: 10.7860/JCDR/2016/21683.8729. Epub 2016 Oct 1.
Results Reference
background
PubMed Identifier
28615976
Citation
Janssen DA, Martens FM, de Wall LL, van Breda HM, Heesakkers JP. Clinical utility of neurostimulation devices in the treatment of overactive bladder: current perspectives. Med Devices (Auckl). 2017 Jun 1;10:109-122. doi: 10.2147/MDER.S115678. eCollection 2017.
Results Reference
background
PubMed Identifier
24353635
Citation
Sensoy N, Dogan N, Ozek B, Karaaslan L. Urinary incontinence in women: prevalence rates, risk factors and impact on quality of life. Pak J Med Sci. 2013 May;29(3):818-22. doi: 10.12669/pjms.293.3404.
Results Reference
background
PubMed Identifier
10900603
Citation
Badia Llach X, Castro Diaz D, Conejero Sugranes J. [Validity of the King's Health questionnaire in the assessment of quality of life of patients with urinary incontinence. The King's Group]. Med Clin (Barc). 2000 May 6;114(17):647-52. doi: 10.1016/s0025-7753(00)71390-x. Spanish.
Results Reference
background
Links:
URL
https://www.sid.ir/FileServer/JE/5074020171248.pdf
Description
The Effect of Electrical Nerve Stimulation in Management of
URL
https://patentimages.storage.googleapis.com/46/03/59/1de87a2e1f5ba6/US6836684.pdf
Description
Method to control an overactive bladder
URL
https://doi.org/10.1016/j.urology.2003.09.050
Description
Describing bladder storage function: overactive bladder syndrome and detrusor overactivity

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Effectiveness of EMS and TENS in Patients With Overactive Bladder

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