Effects of Transcutaneous electrical nerve stimulation at two frequencies on Urinary Incontinence in post stroke patients; A Randomized controlled trial
In order to investigate the effect of different frequencies of TENS in urinary incontinence the current study was planned as no such study was done in not only Pakistan but Asia. The study will investigates the effect of TENS at two frequencies among patients post-stroke urinary symptoms.
Design
Randomised, superiority, parallel group trial with blinded outcome assessment. Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site
Settings and conduct
Rehman Medical Institute, Peshawar
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1. Patients of age <60 years
2. Patients of both genders
Exclusion Criteria:
1. Patients with urinary retention,
2. Patients with a history of UI for various reasons (Parkinson’s disease, spinal cord disease, dementia, urinary tract tumours, urolithiasis, unhealed urinary tract infections, or a history of urinary tract surgery),
Intervention groups
Experimental Group (Group A): The patients in group 1 will receive therapy with TENS for 30 mins once daily for 4 weeks in the hospital (as inpatients or outpatients). The TENS currents will be biphasic square waves with pulse durations of 150 μsecs and pulse frequencies of 75 Hz.
Control Group (Group B): The patients in group 2 will receive therapy with TENS for 30 mins once daily for 4 weeks in the hospital (as inpatients or outpatients). The TENS currents will be biphasic square waves with pulse durations of 150 μsecs and pulse frequencies of 20 Hz.
Main outcome variables
Tools to be used are Overactive Bladder Symptom Score (OABSS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221112056475N1
Registration date:2022-11-15, 1401/08/24
Registration timing:prospective
Last update:2022-11-15, 1401/08/24
Update count:0
Registration date
2022-11-15, 1401/08/24
Registrant information
Name
Sarmad Saeed Khattak
Name of organization / entity
Rehman Medical Institute, Peshawar
Country
Pakistan
Phone
+92 91 5838666
Email address
sarmad.saeed@rmi.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-23, 1401/09/02
Expected recruitment end date
2023-02-23, 1401/12/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Transcutaneous electrical nerve stimulation at two frequencies on Urinary Incontinence in post stroke patients; A Randomized controlled trial
Public title
Effects of Transcutaneous electrical nerve stimulation at two frequencies on Urinary Incontinence in post stroke patients; A Randomized controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with UI after stroke
Patients who were stable, cooperative, and could effectively communicate (to participate in therapy
Patients who could complete the survey on urination both before and after treatment
Exclusion criteria:
Patients with urinary retention
Patients with a history of UI for various reasons (Parkinson’s disease, spinal cord disease, dementia, urinary tract tumours, urolithiasis, unhealed urinary tract infections, or a history of urinary tract surgery)
Patients who needed significant fluid infusions or drugs that affected urination
Patients with concurrent serious organic diseases
Patients with severe cognitive functioning disorders (Mini-Mental State Examination10 score <22 points)
Age
To 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
Following the selection of patients and the assessment of baseline similarities, the included participants will be randomly assigned to the control and experimental groups using the sealed envelops method.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the nature of the study, blinding the researcher/therapist and subjects will not be feasible. However, the assessor, who will compare pre and post scores will be blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Advance Studies & Research Board (AS&RB)
Street address
F1 Phase-6 Rd, Phase 5 Hayatabad, Peshawar, Khyber Pakhtunkhwa 25100
City
Peshawar
Postal code
25100
Approval date
2022-11-13, 1401/08/22
Ethics committee reference number
KMU/IPMR/MSPT/007
Health conditions studied
1
Description of health condition studied
Urinary Incontinence
ICD-10 code
N39.4
ICD-10 code description
Other specified urinary incontinence
Primary outcomes
1
Description
Overactive Bladder Symptom Score (OABSS)
Timepoint
Pre intervention and after 4 weeks of intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patients in group 1 will receive therapy with TENS (model EN-Stim 4; ENRAF-NONIUS Company Ltd, Rotterdam, the Netherlands) for 30 mins once daily for 4 weeks in the hospital (as inpatients or outpatients). The TENS device will use a four-channel stimulator with fully independent channels and four sets of moist pads for rubber electrodes (6 × 8 cm). This process will make it possible to treat major muscle groups simultaneously or to perform bilateral treatments simultaneously. The TENS currents will be biphasic square waves with pulse durations of 150 μsecs and pulse frequencies of 75 Hz.
Category
Treatment - Devices
2
Description
Control group: The patients in group 2 will receive therapy with TENS (model EN-Stim 4; ENRAF-NONIUS Company Ltd, Rotterdam, the Netherlands) for 30 mins once daily for 4 weeks in the hospital (as inpatients or outpatients). The TENS device will use a four-channel stimulator with fully independent channels and four sets of moist pads for rubber electrodes (6 × 8 cm). This process will make it possible to treat major muscle groups simultaneously or to perform bilateral treatments simultaneously. The TENS currents will be biphasic square waves with pulse durations of 150 μsecs and pulse frequencies of 20 Hz.