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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
eman elhosary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring stress urinary incontinence, TECAR

Eligibility Criteria

30 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    October 27, 2020
    Last Updated
    October 27, 2020
    Sponsor
    eman elhosary
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    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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