Effect of TECAR in Treating Stress Urinary Incontinence
Primary Purpose
Stress Urinary Incontinence
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TECAR followed by pelvic floor exercises
pelvic floor exercises
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring stress urinary incontinence, TECAR
Eligibility Criteria
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
-
Exclusion Criteria:
- Those with neurological diseases, diabetic neuropathy, congenital urologic disease, bladder cancer and neurogenic bladder, detrusor hyperactivity and bladder or urethra previous surgery
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
group A
group B
Arm Description
females complain from SUI treated by TECAR and pelvic floor exercises
females treated by pelvic floor exercises only
Outcomes
Primary Outcome Measures
strength of pelvic floor
strength of pelvic floor muscles measured by perineometer before treatment and after 4 weeks
Secondary Outcome Measures
severity of SUI
measured by visual analogue scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04612205
Brief Title
Effect of TECAR in Treating Stress Urinary Incontinence
Official Title
Effect of TECAR in Treating Stress Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 2020 (Anticipated)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
eman elhosary
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
stress urinary incontinence, TECAR
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Experimental
Arm Description
females complain from SUI treated by TECAR and pelvic floor exercises
Arm Title
group B
Arm Type
Active Comparator
Arm Description
females treated by pelvic floor exercises only
Intervention Type
Device
Intervention Name(s)
TECAR followed by pelvic floor exercises
Intervention Description
The signal generator was an INDIBA® 448 kHz RF device (vagina/rectum) (INDIBA SA, Barcelona, Spain).
Intervention Type
Other
Intervention Name(s)
pelvic floor exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
strength of pelvic floor
Description
strength of pelvic floor muscles measured by perineometer before treatment and after 4 weeks
Time Frame
after 4 week
Secondary Outcome Measure Information:
Title
severity of SUI
Description
measured by visual analogue scale
Time Frame
after 4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
-
Exclusion Criteria:
Those with neurological diseases, diabetic neuropathy, congenital urologic disease, bladder cancer and neurogenic bladder, detrusor hyperactivity and bladder or urethra previous surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
eman elhosary
Phone
0021276754277
Email
emanabdelfatah123@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
eman elhosary
Organizational Affiliation
kafr elshekh university
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of TECAR in Treating Stress Urinary Incontinence
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