Effect of TECAR in Treating Stress Urinary Incontinence

Stress urinary incontinence (SUI) is the defined as a leakage of urine with physical exertion, most commonly from coughing, laughing, or sneezing. It has a profound psychosocial impact not only to patients but also on their families and caregivers, resulting in loss of self stem, sexual dysfunction.Because of the higher incidence of stress urinary incontinence that reach 30% of women during childbearing period, 50% in elderly women, and its social embarrassing condition causing socio-psychological problems, disability and dependency with higher economic impact and based on TECAR therapy had better recovery of muscle strength and function in addition to there is no study has evaluated the impact of TECAR treatment on stress urinary incontinence, our study aim to assess the effectiveness of TECAR in treatment of such cases to decrease time of treatment and provide good results to patients.

Study Overview

• Status: Unknown
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: TECAR followed by pelvic floor exercises; Other: pelvic floor exercises

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:Participants aged between30 to 50 year and BMI not exceed 30 kg/cm2. All subjects complain from mild SUI due to hypermobility of bladder neck and weakness of pelvic floor exercise

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Exclusion Criteria:

• Those with neurological diseases, diabetic neuropathy, congenital urologic disease, bladder cancer and neurogenic bladder, detrusor hyperactivity and bladder or urethra previous surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A; females complain from SUI treated by TECAR and pelvic floor exercises	Device: TECAR followed by pelvic floor exercises; The signal generator was an INDIBA® 448 kHz RF device (vagina/rectum) (INDIBA SA, Barcelona, Spain).
Active Comparator: group B; females treated by pelvic floor exercises only	Other: pelvic floor exercises; The patients will instructed to contract their pelvic floor muscles without contracting adjacent muscles, such as the abdomen, glutei and hip adductors muscles twenty repletion consisted of contraction and squeezing of the muscle ten seconds followed by relaxation for twenty second then rested for two minutes. The exercises program lasted for lasting 45 min. divided into 5 min. warming up, 35 min. actual treatment and 5 min. cooling down, three times a week for eight consecutive weeks. The patient will teach to contract their pelvic floor muscles before coughing or sneezing thus to prevent leakage. Home exercises through continuing practicing these contractions as frequent as possible according to her ability, at early morning before getting from bed from crock lying position, at afternoon from sitting and standing positions, at evening from sitting and standing positions and finally at night at bed time from crock lying position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
strength of pelvic floor	strength of pelvic floor muscles measured by perineometer before treatment and after 4 weeks	after 4 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
severity of SUI	measured by visual analogue scale	after 4 weeks

Collaborators and Investigators

• Sponsor: eman elhosary
• Investigators: Principal Investigator: eman elhosary, Kafr Elshekh university

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2020
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: October 27, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): November 2, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: stress urinary incontinence, TECAR
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: tecar & stress incontinence

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No