Overactive Bladder SyndromeNCT06045728
Telerehabilitation for Overactive Bladder Syndrome in Obese Women
A study testing Pilates exercises and Mediterranean diet in people with Overactive Bladder Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
Overactive bladder syndrome(OAB) is a chronic medical condition which has a major influence on the quality of life in a significant amount of the population. The goal of this clinical trial study to identify the effect of telerehabilitation program on overactive bladder symptoms and metabolic health in obese women and… Read more about this study
- Who is it for?
- Ages 35 to 45 years, women only
- Conditions the study is for
- Overactive Bladder Syndrome
- What is being tested?
- Pilates exercises and Mediterranean diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2023to 30 Dec 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women aged 35-45 years old
- class I obesity(30-34.9kg/m2)
- women will be referred by urologist with Presence of overactive bladder symptoms confirmed by overactive bladder questionnaire
- waist circumference more than 88 cm
Who cannot join
- history of surgical treatment of urological disease
- infection of urinary tract
- oncological and neurological urinary tract disease,
- refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Online Video Programs With Patients Referred From Urologist ( Kasr Eleiny Hospital)
Giza
salma I alghitany, phd, 01229723881, fardreams@yahoo.com
About this study
Official title: Effect of Telerehabilitation on Overactive Bladder Symptoms and Metabolic Health in Obese Women
Overactive bladder syndrome(OAB) is a chronic medical condition which has a major influence on the quality of life in a significant amount of the population. The goal of this clinical trial study to identify the effect of telerehabilitation program on overactive bladder symptoms and metabolic health in obese women and to compare between the telerehabilitation group and the control group regarding overactive bladder symptoms and metabolic health in obese women.
Read the detailed description
overactive bladder syndrome occurs globally and affects both genders with studies indicating high prevalence in obese females. Obesity brings with it not only an increased risk of cardiovascular diseases, but also urological dysfunction including overactive bladder. Pilates exercise and diet can be used as ways for controlling overactive bladder symptoms and improving overall health of obese subjects. Integration of telerehabilitation in the clinical practice benefits both providers and patients as well decreasing healthcare costs, so the objective of this study to determine the effect of telerehabilitation on overactive bladder symptoms and metabolic health in obese women through Pilates exercise and Mediterranean diet .
- Conditions
- Overactive Bladder Syndrome
- Being tested
- Pilates exercises, Mediterranean diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates exercisesOther
Pilates is a group of low impact muscle exercises that strengthen abdominal muscles, back, hips and pelvic floor muscles. the exercise consists of 10 min warm up, 40 min exercise and 10 min cooling down. the exercises that will be included: spine twist, double leg stretch, double leg circles, side leg circle, curl up, shoulder bridges and pelvic curl.
Mediterranean dietBehavioural
it is a type of diet used for obesity management based on high vegetable intake, olive oil as a source of fat, the consumption of grains, legumes, and nuts with high amounts of pulp, low-medium consumption of fish, low consumption of red meat.
| Study group | Role | What they receive |
|---|---|---|
| group 1 telerehabilitation group | Active comparator | subjects in this group will receive telerehabilitation sessions through online video programs (including Pilates exercise and diet) 3 times per week for 12 weeks. Outcome measures will be evaluated at baseline and after 12 weeks Receives: Other: Pilates exercises; Behavioral: Mediterranean diet |
| group 2 control group | Other | subjects in this group will be informed about the importance of Pilates exercise and diet for one session only. subjects will be asked to apply the exercise at home 3 times per week for 12 weeks and diet. Outcome measures will be evaluated at baseline and after 12 weeks Receives: Other: Pilates exercises; Behavioral: Mediterranean diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
body mass index
it is calculated by dividing weight in kg on height in m square
Measured: at baseline and after 12 weeks of the intervention
waist circumference
it is an indicator of central obesity with waist circumference more than 88 cm is considered central obesity in females
Measured: at baseline and after 12 weeks of the intervention
overactive bladder questionnaire short form
is a questionnaire that is divided into two sections : symptoms and quality of life. In symptoms section, the higher the scores the more the symptoms that bother the patients. higher scores in quality of life section indicates better quality of life.
Measured: at baseline and after 12 weeks of the intervention
patient perception of intensity of urgency scale
a scale ranges from 0 to 4 that measures the degree of urgency with micturition with higher scores indicate higher perception of urgency
Measured: at baseline and after 12 weeks of the intervention
HOMA IR
The homeostatic model assessment (HOMA IR) is a method used to quantify insulin resistance . derived from the product of the insulin and glucose values divided by a constant.
Measured: at baseline and after 12 weeks of the intervention
Secondary outcomes (1)
telehealth usability questionnaire
a comprehensive questionnaire that covers all usability factors (i.e., usefulness, ease of use, effectiveness, reliability, and satisfaction). It is used with various types of telehealth systems, including the traditional videoconferencing systems, computer-based systems, and the mobile telehealth systems.
Measured: after 12 weeks of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start15 Sep 2023 (estimated)
- Primary completion15 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Ibrahim Abdelmohsen Alghitany, Cairo University
- Investigators
- salma I alghitany, PHD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045728
- Sponsor's protocol ID
- P.T.REC/012/004621
- Status last verified
- Sep 2023
- First submitted
- 13 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Telerehabilitation on Overactive Bladder Symptoms and Metabolic Health in Obese Women
- ClinicalTrials.gov ID
- NCT06045728
- Acronym / sponsor ID
- P.T.REC/012/004621
- Conditions
- Overactive Bladder Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Sep 2023 (estimated)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 21 Sep 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.
Overactive bladder syndrome(OAB) is a chronic medical condition which has a major influence on the quality of life in a significant amount of the population. The goal of this clinical trial study to identify the effect of telerehabilitation program on overactive bladder symptoms and metabolic health in obese women and to compare between the telerehabilitation group and the control group regarding overactive bladder symptoms and metabolic health in obese women.
Detailed description
overactive bladder syndrome occurs globally and affects both genders with studies indicating high prevalence in obese females. Obesity brings with it not only an increased risk of cardiovascular diseases, but also urological dysfunction including overactive bladder. Pilates exercise and diet can be used as ways for controlling overactive bladder symptoms and improving overall health of obese subjects. Integration of telerehabilitation in the clinical practice benefits both providers and patients as well decreasing healthcare costs, so the objective of this study to determine the effect of telerehabilitation on overactive bladder symptoms and metabolic health in obese women through Pilates exercise and Mediterranean diet .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 telerehabilitation group | Active comparator | Other: Pilates exercises, Behavioral: Mediterranean dietsubjects in this group will receive telerehabilitation sessions through online video programs (including Pilates exercise and diet) 3 times per week for 12 weeks. Outcome measures will be evaluated at baseline and after 12 weeks |
| group 2 control group | Other | Other: Pilates exercises, Behavioral: Mediterranean dietsubjects in this group will be informed about the importance of Pilates exercise and diet for one session only. subjects will be asked to apply the exercise at home 3 times per week for 12 weeks and diet. Outcome measures will be evaluated at baseline and after 12 weeks |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- women aged 35-45 years old
- class I obesity(30-34.9kg/m2)
- women will be referred by urologist with Presence of overactive bladder symptoms confirmed by overactive bladder questionnaire
- waist circumference more than 88 cm
Key exclusion criteria (4 listed)
- history of surgical treatment of urological disease
- infection of urinary tract
- oncological and neurological urinary tract disease,
- refusal to participate in the study
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 |
|---|---|---|
| Pilates exercisesPilates is a group of low impact muscle exercises that strengthen abdominal muscles, back, hips and pelvic floor muscles. the exercise consists of 10 min warm up, 40 min exercise and 10 min cooling down. the exercises that will be included: spine twist, double leg stretch, double leg circles, side leg circle, curl up, shoulder bridges and pelvic curl. | Other | group 1 telerehabilitation group, group 2 control group |
| Mediterranean dietit is a type of diet used for obesity management based on high vegetable intake, olive oil as a source of fat, the consumption of grains, legumes, and nuts with high amounts of pulp, low-medium consumption of fish, low consumption of red meat. | Behavioural | group 1 telerehabilitation group, group 2 control group |
Primary outcome
body mass index
Time frame: at baseline and after 12 weeks of the intervention
it is calculated by dividing weight in kg on height in m square
waist circumference
Time frame: at baseline and after 12 weeks of the intervention
it is an indicator of central obesity with waist circumference more than 88 cm is considered central obesity in females
overactive bladder questionnaire short form
Time frame: at baseline and after 12 weeks of the intervention
is a questionnaire that is divided into two sections : symptoms and quality of life. In symptoms section, the higher the scores the more the symptoms that bother the patients. higher scores in quality of life section indicates better quality of life.
patient perception of intensity of urgency scale
Time frame: at baseline and after 12 weeks of the intervention
a scale ranges from 0 to 4 that measures the degree of urgency with micturition with higher scores indicate higher perception of urgency
HOMA IR
Time frame: at baseline and after 12 weeks of the intervention
The homeostatic model assessment (HOMA IR) is a method used to quantify insulin resistance . derived from the product of the insulin and glucose values divided by a constant.
1 secondary outcome
telehealth usability questionnaire
Time frame: after 12 weeks of the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Relationship Between Central Obesity, General Obesity, Overactive Bladder Syndrome and Urinary Incontinence Among Male and Female Patients Seeking Care for Their Lower Urinary Tract SymptomsLink provided by the sponsor.
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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.
salma I alghitany, PHD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates exercises and Mediterranean diet in people with Overactive Bladder Syndrome, run by Cairo University 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 4 inclusion and 4 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 21 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact salma I alghitany, PHD (01229723881, fardreams@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body mass index (time frame: at baseline and after 12 weeks of the intervention). The study lists 5 primary outcomes in all. 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 21 Sep 2023.