CClinicalTrials.gg
Status unknownNCT04612205Updated Nov 2, 2020

Effect of TECAR in Treating Stress Urinary Incontinence

An interventional study of TECAR followed by pelvic floor exercises and pelvic floor exercises in Stress Urinary Incontinence, sponsored by eman elhosary. Status unknown. Open to female participants aged 30 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-11-02.

Sponsored by eman elhosary · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
30 Years to 50 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Stress Urinary Incontinence

Keywords

  • stress urinary incontinence, TECAR
03

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's planned enrollment of 40 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

This is the only study on the registry with eman elhosary as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
Female
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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    group A

    females complain from SUI treated by TECAR and pelvic floor exercises

    Device: TECAR followed by pelvic floor exercises

  • Active comparator
    group B

    females treated by pelvic floor exercises only

    Other: pelvic floor exercises

Interventions

  • DeviceTECAR followed by pelvic floor exercises

    The signal generator was an INDIBA® 448 kHz RF device (vagina/rectum) (INDIBA SA, Barcelona, Spain).

  • Otherpelvic 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.

06

What researchers measure

Primary outcomes

  1. strength of pelvic floor

    strength of pelvic floor muscles measured by perineometer before treatment and after 4 weeks

    Time frame: after 4 week

Secondary outcomes

  1. severity of SUI

    measured by visual analogue scale

    Time frame: after 4 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04612205
Lead sponsor
eman elhosary
Responsible party
eman elhosary (assist .Prof.of women health department, Kafrelsheikh University) — Sponsor-investigator
First posted
Nov 2, 2020
Start date
Dec 2020 (estimated)
Primary completion
Apr 2021 (estimated)
Completion
Jun 2021 (estimated)
Last update
Nov 2, 2020

Study contacts

eman elhosary
Contact
emanabdelfatah123@yahoo.com
0021276754277
eman elhosary
principal investigator · kafr elshekh university

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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