Stress Urinary IncontinenceNCT04612205
Effect of TECAR in Treating Stress Urinary Incontinence
A study testing TECAR followed by pelvic floor exercises and pelvic floor exercises in people with Stress Urinary Incontinence, run by eman elhosary.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- TECAR followed by pelvic floor exercises and pelvic floor exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Those with neurological diseases, diabetic neuropathy, congenital urologic disease, bladder cancer and neurogenic bladder, detrusor hyperactivity and bladder or urethra previous surgery
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Stress Urinary Incontinence
- Being tested
- TECAR followed by pelvic floor exercises, pelvic floor exercises
- Keywords
- stress urinary incontinence, TECAR
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TECAR followed by pelvic floor exercisesDevice
The signal generator was an INDIBA® 448 kHz RF device (vagina/rectum) (INDIBA SA, Barcelona, Spain).
pelvic floor exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | females complain from SUI treated by TECAR and pelvic floor exercises Receives: Device: TECAR followed by pelvic floor exercises |
| group B | Active comparator | females treated by pelvic floor exercises only Receives: Other: pelvic floor exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
strength of pelvic floor
strength of pelvic floor muscles measured by perineometer before treatment and after 4 weeks
Measured: after 4 week
Secondary outcomes (1)
severity of SUI
measured by visual analogue scale
Measured: after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study startDec 2020 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- eman elhosary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, eman elhosary, Kafrelsheikh University
- Investigators
- eman elhosary, Principal investigator, kafr elshekh university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612205
- Sponsor's protocol ID
- tecar & stress incontinence
- Status last verified
- Oct 2020
- First submitted
- 27 Oct 2020
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elhosary EA, Ahmed Hamada H, Ali AlMubali F, Lopez Sanchez GF, Ahmed SM. Effect of monopolar capacitive resistive radiofrequency in treating stress urinary incontinence: A pilot randomized control trial. Front Psychol. 2023 Jan 5;13:1062363. doi: 10.3389/fpsyg.2022.1062363. eCollection 2022.
PubMed 36687887
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of TECAR in Treating Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT04612205
- Acronym / sponsor ID
- tecar & stress incontinence
- Conditions
- Stress Urinary Incontinence
- Keywords
- stress urinary incontinence, TECAR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- eman elhosaryUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 2 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Device: TECAR followed by pelvic floor exercisesfemales complain from SUI treated by TECAR and pelvic floor exercises |
| group B | Active comparator | Other: pelvic floor exercisesfemales treated by pelvic floor exercises only |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Those with neurological diseases, diabetic neuropathy, congenital urologic disease, bladder cancer and neurogenic bladder, detrusor hyperactivity and bladder or urethra previous surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TECAR followed by pelvic floor exercisesThe signal generator was an INDIBA® 448 kHz RF device (vagina/rectum) (INDIBA SA, Barcelona, Spain). | Device | group A |
| pelvic floor exercisesThe 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. | Other | group B |
Primary outcome
strength of pelvic floor
Time frame: after 4 week
strength of pelvic floor muscles measured by perineometer before treatment and after 4 weeks
1 secondary outcome
severity of SUI
Time frame: after 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Derived from this study: PubMed 36687887Elhosary EA, Ahmed Hamada H, Ali AlMubali F, Lopez Sanchez GF, Ahmed SM. Effect of monopolar capacitive resistive radiofrequency in treating stress urinary incontinence: A pilot randomized control trial. Front Psychol. 2023 Jan 5;13:1062363. doi: 10.3389/fpsyg.2022.1062363. eCollection 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
eman elhosary principal investigator
kafr elshekh university
Questions about this trial
What is this clinical trial studying?
A study testing TECAR followed by pelvic floor exercises and pelvic floor exercises in people with Stress Urinary Incontinence, run by eman elhosary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact eman elhosary (0021276754277, emanabdelfatah123@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
strength of pelvic floor (time frame: after 4 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04612205, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.