Effectiveness of EMS and TENS in Patients With Overactive Bladder

NCT04364438 | Unknown DMC

• 1 other identifier: 1502-PhD-007
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder

Keywords

Urinary Bladder, Overactive; Urinary Incontinence; Quality of Life; Transcutaneous Electric Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline and week 12

Secondary Outcomes (1)

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

  Baseline and week 12

Study Arms (3)

Control Group

NO INTERVENTION

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

EMS Group

EXPERIMENTAL

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

TENS Group

EXPERIMENTAL

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

Interventions

Electric Muscle Stimulation DEVICE

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.

Also known as: EMS

EMS Group

Transcutaneous Electric Nerve Stimulation DEVICE

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.

Also known as: TENS

TENS Group

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Isra University: lead

Study Sites (1)

Sajid Rashid

Multan Khurd, Punjab Province, 60000, Pakistan

RECRUITING

Related Publications (7)

• 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.

  PMID: 19913821 BACKGROUND

• 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.

  PMID: 26073262 BACKGROUND

• 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.

  PMID: 23240797 BACKGROUND

• 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.

  PMID: 27891403 BACKGROUND

• 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.

  PMID: 28615976 BACKGROUND

• 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.

  PMID: 24353635 BACKGROUND

• 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.

  PMID: 10900603 BACKGROUND

Related Links

• The Effect of Electrical Nerve Stimulation in Management of
• Method to control an overactive bladder
• Describing bladder storage function: overactive bladder syndrome and detrusor overactivity

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; 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; Urination Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Naveed Babur, Ph.D

  Isra University, Islamabad

  STUDY CHAIR

Central Study Contacts

Sajid Rashid, M.Phil

CONTACT

00923006309825; sajidch71@hotmail.com

Rehan Khan, M.Phil

CONTACT

00923343074756; rehan99physio@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 28, 2020
• Study Start: March 3, 2020
• Primary Completion: April 1, 2021
• Study Completion: September 1, 2021
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)