Stress Urinary IncontinenceNCT05944484
Effect of Visceral vs Total Body Fat Reduction in Obese Female With Stress Urinary Incontinence
A study testing low caloric diet, ultrasound cavitation,Kegel exercises in people with Stress Urinary Incontinence, run by Dina Mohamed Tarek Mansour El-kasrawy at 1 site in Egypt.
Trial summary
The aim of this study is to investigate the visceral fat reduction versus total body fat reduction on stress urinary incontinence in obese females. Read more about this study
- Who is it for?
- Ages 35 to 48 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- low caloric diet, ultrasound cavitation,Kegel exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Nov 2020to 5 Jun 2023
- 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 35 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- They will be diagnosed with stress urinary incontinence grade≥ 1
- Their age will range from 35-48 years old.
- Their body mass index will exceed 29.9 kg/m².
- Their hip waist ratio will be more than 0.85 cm.
- They will be multipara >1.
Who cannot join
- · Fecal incontinence, urge incontinence, overflow incontinence or functional incontinence or prolapse.
- Diabetes, asthma, cardiovascular, or renal diseases
- Taking medication for stress urinary incontinence or hormonal replacement therapy.
- Gynecological surgeries, or surgeries for obesity.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Visceral vs Total Body Fat Reduction in Obese Female With Stress Urinary Incontinence by EMG and Iciq Questionnaire
The aim of this study is to investigate the visceral fat reduction versus total body fat reduction on stress urinary incontinence in obese females.
Read the detailed description
compare the effect of visceral fat reduction versus total body fat reduction on stress urinary incontinence in obese females.
control group: consist of 20 obese women. They will receive Kegel exercises only 3 session/ week for 12 weeks.
Diet group: consist of 20 obese women. They will receive low caloric diet and Kegel exercises 3 session/week for 12 weeks.
Ultrasound cavitation group: consist of 20 obese women. They will receive Kegel exercises 3 session/week and ultrasound cavitation two sessions per week.
- Conditions
- Stress Urinary Incontinence
- Being tested
- low caloric diet, ultrasound cavitation,Kegel exercises
- Keywords
- Visceral fat, total body fat, obese female, stress urinary incontinence
- 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.
low caloric diet, ultrasound cavitation,Kegel exercisesBehavioural
- low caloric diet (800-1200) calories/day,). According to each patient, diet contained (carbohydrate protein, fats, minerals, vitamins). 50 to 55% of total calories are carbohydrates, 10 to 15% of total calories protein. Fat limited to less than about 28% of daily total calories .Women took 1200 calories in the first month, 1000 calories in the second month, and 800 calories in the third month. Every week, each woman allowed to change the types of food to avoid boarding.
- ultrasound cavitation emits low-frequency ultrasound 40 khz for 30 minutes on abdomen twice/ week with 3 days apart for 12 weeks. kegel exercise: Each woman in the study took the same Kegel exercise program performed the Kegel exercise for 12 weeks (3 sessions per week)
| Study group | Role | What they receive |
|---|---|---|
| kegel exercises | Active comparator | Kegel exercise program performed for 12 weeks( 3 sessions /week )
.• "The first step is external observation, with the patient in the lithotomy position.And describe for each woman how to feel her muscle when she stops mid-stream urine.
* "The second step is vaginal examination, performed gently with one finger." - The digital exam served a double purpose: first to assess the development of the puboccocygeus muscle and second to verify that the patient was able to identify the correct muscle
* The third stage main exercises quick flick : contract muscle as quickly as possible 10-20 times then relax then count 10 for relax then reapeat .( 50 repetitions) slow contraction: tighten the muscle as hard as you can for account of 10 -20 .relax for acount 10 then repeat ( 50 repetitions) sustained contraction: tighten the muscle halfway and hold 60 seconds .relax for account 20 then repeat (10 repetitions) Receives: Behavioral: low caloric diet, ultrasound cavitation,Kegel exercises |
| low caloric diet | Active comparator | low caloric diet (800-1200) calories/day . According to each patient, diet should contain (carbohydrate protein, fats, minerals, vitamins),1200 calories in the first month, 1000 calories in the second month, and 800 calories in the third month. Every week, each woman will be allowed to change the types of food to avoid boarding. Receives: Behavioral: low caloric diet, ultrasound cavitation,Kegel exercises |
| ultrasound cavitation | Active comparator | ultrasound cavitation, for 30 minutes on abdomen with continuous emission and frequency of 40 KHz, 3-6 W/cm2, 60W with 10cm2 active surface, twice/ week with 3 days apart for 12 weeks. Receives: Behavioral: low caloric diet, ultrasound cavitation,Kegel exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
stress urinary incontinence
evaluate stress urinary incontinence by The International Consultation on Incontinence Questionnaire ranged from (0-21)
Question items:
Frequency or urinary incontinence Amount of leakage Overall impact of urinary incontinence Self-diagnostic item. The ICIQ-UI Short form provides a score ranging from 0-21. With a higher score indicating greater severity of symptoms. The "self-diagnostic" portion of the questionnaire is not given a score
Measured: 12 weeks
Secondary outcomes (3)
waist circumference
measure waist circumference in centimeter
Measured: 12 weeks
Measure weight
Measure weight in kilogram
Measured: 12 weeks
Measure body mass index
weight and height will be combined to report BMI in kg/m^2
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start30 Nov 2020
- Primary completion5 May 2023
- Study completion5 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Visceral fat reduction vs total body fat reduction on obese female with stress urinary incontinence
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dina Mohamed Tarek Mansour El-kasrawy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dina Mohamed Tarek Mansour El-kasrawy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944484
- Sponsor's protocol ID
- Effect of fat on SUI
- Status last verified
- Jun 2023
- First submitted
- 11 Jun 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Visceral vs Total Body Fat Reduction in Obese Female With Stress Urinary Incontinence by EMG and Iciq Questionnaire
- ClinicalTrials.gov ID
- NCT05944484
- Acronym / sponsor ID
- Effect of fat on SUI
- Conditions
- Stress Urinary Incontinence
- Keywords
- Visceral fat, total body fat, obese female, stress urinary incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dina Mohamed Tarek Mansour El-kasrawyUniversity, hospital or other
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 5 Jun 2023 (actual)
- First posted
- 13 Jul 2023 (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.
The aim of this study is to investigate the visceral fat reduction versus total body fat reduction on stress urinary incontinence in obese females.
Detailed description
compare the effect of visceral fat reduction versus total body fat reduction on stress urinary incontinence in obese females.
control group: consist of 20 obese women. They will receive Kegel exercises only 3 session/ week for 12 weeks.
Diet group: consist of 20 obese women. They will receive low caloric diet and Kegel exercises 3 session/week for 12 weeks.
Ultrasound cavitation group: consist of 20 obese women. They will receive Kegel exercises 3 session/week and ultrasound cavitation two sessions per week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Visceral fat reduction vs total body fat reduction on obese female with stress urinary incontinence
| Arm | Type | Receives |
|---|---|---|
| kegel exercises | Active comparator | Behavioral: low caloric diet, ultrasound cavitation,Kegel exercisesKegel exercise program performed for 12 weeks( 3 sessions /week ) .• "The first step is external observation, with the patient in the lithotomy position.And describe for each woman how to feel her muscle when she stops mid-stream urine. * "The second step is vaginal examination, performed gently with one finger." - The digital exam served a double purpose: first to assess the development of the puboccocygeus muscle and second to verify that the patient was able to identify the correct muscle * The third stage main exercises quick flick : contract muscle as quickly as possible 10-20 times then relax then count 10 for relax then reapeat .( 50 repetitions) slow contraction: tighten the muscle as hard as you can for account of 10 -20 .relax for acount 10 then repeat ( 50 repetitions) sustained contraction: tighten the muscle halfway and hold 60 seconds .relax for account 20 then repeat (10 repetitions) |
| low caloric diet | Active comparator | Behavioral: low caloric diet, ultrasound cavitation,Kegel exerciseslow caloric diet (800-1200) calories/day . According to each patient, diet should contain (carbohydrate protein, fats, minerals, vitamins),1200 calories in the first month, 1000 calories in the second month, and 800 calories in the third month. Every week, each woman will be allowed to change the types of food to avoid boarding. |
| ultrasound cavitation | Active comparator | Behavioral: low caloric diet, ultrasound cavitation,Kegel exercisesultrasound cavitation, for 30 minutes on abdomen with continuous emission and frequency of 40 KHz, 3-6 W/cm2, 60W with 10cm2 active surface, twice/ week with 3 days apart for 12 weeks. |
Who may qualify
- Ages
- 35 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- They will be diagnosed with stress urinary incontinence grade≥ 1
- Their age will range from 35-48 years old.
- Their body mass index will exceed 29.9 kg/m².
- Their hip waist ratio will be more than 0.85 cm.
- They will be multipara >1.
Key exclusion criteria (5 listed)
- · Fecal incontinence, urge incontinence, overflow incontinence or functional incontinence or prolapse.
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 |
|---|---|---|
| low caloric diet, ultrasound cavitation,Kegel exercises* low caloric diet (800-1200) calories/day,). According to each patient, diet contained (carbohydrate protein, fats, minerals, vitamins). 50 to 55% of total calories are carbohydrates, 10 to 15% of total calories protein. Fat limited to less than about 28% of daily total calories .Women took 1200 calories in the first month, 1000 calories in the second month, and 800 calories in the third month. Every week, each woman allowed to change the types of food to avoid boarding. * ultrasound cavitation emits low-frequency ultrasound 40 khz for 30 minutes on abdomen twice/ week with 3 days apart for 12 weeks. kegel exercise: Each woman in the study took the same Kegel exercise program performed the Kegel exercise for 12 weeks (3 sessions per week) | Behavioural | kegel exercises, low caloric diet, ultrasound cavitation |
Primary outcome
stress urinary incontinence
Time frame: 12 weeks
evaluate stress urinary incontinence by The International Consultation on Incontinence Questionnaire ranged from (0-21) Question items: Frequency or urinary incontinence Amount of leakage Overall impact of urinary incontinence Self-diagnostic item. The ICIQ-UI Short form provides a score ranging from 0-21. With a higher score indicating greater severity of symptoms. The "self-diagnostic" portion of the questionnaire is not given a score
3 secondary outcomes
waist circumference
Time frame: 12 weeks
Measure weight
Time frame: 12 weeks
Measure body mass index
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low caloric diet, ultrasound cavitation,Kegel exercises in people with Stress Urinary Incontinence, run by Dina Mohamed Tarek Mansour El-kasrawy at 1 site in Egypt.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stress urinary incontinence (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2023.