]>
IRCT20221112056475N1 IRCT 2022-11-15 Khyber Medical University, Peshawar Effects of Transcutaneous electrical nerve stimulation at two frequencies on Urinary Incontinence in post stroke patients; A Randomized controlled trial Effects of Transcutaneous electrical nerve stimulation at two frequencies on Urinary Incontinence in post stroke patients; A Randomized controlled trial 2022-11-23 anticipated 98 Complete https://irct.ir/trial/66841 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Urinary Incontinence. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is To keep data confidential and not available for copying
public Mujeeb Ur Rahman
F1 Phase-6 Rd, Phase 5 Hayatabad, Peshawar, Khyber Pakhtunkhwa 25100
Peshawar Pakistan 25100 +92 91 9217703 mujeeb.rahman@kmu.edu.pk Khyber Medical University, Peshawar scientific Sarmad Saeed Khattak
5-B/2 Shaukat Khanum Rd, Phase 5 Hayatabad, Peshawar, Khyber Pakhtunkhwa 25000
Peshawar Pakistan 25000 +92 91 5838666 sarmad.saeed@rmi.edu.pk Rehman Medical Institute, Peshawar Pakistan 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 no limit 60 years Both 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) N39.4 Other specified urinary incontinence Treatment - Devices Treatment - Devices 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. 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. Overactive Bladder Symptom Score (OABSS). Timepoint: Pre intervention and after 4 weeks of intervention. Method of measurement: Questionnaire. Khyber Medical University, Peshawar Approved 2022-11-13 Advance Studies & Research Board (AS&RB) F1 Phase-6 Rd, Phase 5 Hayatabad, Peshawar, Khyber Pakhtunkhwa 25100 Peshawar Khyber Pakhtunkhwa Pakistan