Stress Urinary IncontinenceNCT06189443
Abdominal-Kegel Exercise and the Effect of Telemedicine in Stress Urinary Incontinence
A study testing Group administered to individual telemedicine in people with Stress Urinary Incontinence, run by Eskisehir Osmangazi University at 2 sites in Turkey (Türkiye).
Trial summary
Urinary incontinence is a very common health problem that reduces the quality of life mostly in women. Behavioral therapy (lifestyle changes, abdominal-Kegel exercises) is recommended as the first choice in the treatment of the disease. It is known that surgical and medical treatment cannot give a definite result. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Group administered to individual telemedicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 30 Jul 2024
- 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 20 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- having symptoms of UI for at least the last 6 months,
- QUID stress score is ≥ 4,
- diagnosed with SUI as a result of the evaluation made by a specialist physician, have minimal skills in using new technologies
- Those who have the opportunity to access the web page to be prepared can participate in the research.
Who cannot join
- History of using medical therapy for UI,
- existing urinary infection,
- diabetes mellitus,
- nervous system disease (such as multiple sclerosis, cerebrovascular disease),
- psychiatric illness or dementia,
- genitourinary malignancy,
- having limited range of motion in the foot or pelvic region,
- pregnant
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Eskisehir Osmangazi University Faculty of Medicine
Eskişehir, Tepebaşı, 26000
Eskişehir Osmangazi Üniversitesi Tıp Fakültesi
Eskişehir
About this study
Official title: Abdominal-Kegel Exercise in Patients With Stress Urinary Incontinence and the Effect of Telemedicine Applications on Adaptation to Lifestyle Changes: A Randomized Controlled Study
Urinary incontinence is a very common health problem that reduces the quality of life mostly in women. Behavioral therapy (lifestyle changes, abdominal-Kegel exercises) is recommended as the first choice in the treatment of the disease. It is known that surgical and medical treatment cannot give a definite result. The application of behavioral therapy with telemedicine has advantages such as reducing the cost and increasing the treatment rate. In this study, it is aimed to evaluate the effect of telemedicine practices on compliance with multi-module behavioral therapy in women with stress urinary incontinence.
Read the detailed description
The study is a randomized controlled study to be conducted in female patients between the ages of 20-65 who applied to the Eskişehir City Hospital urology outpatient clinic and diagnosed with stress urinary incontinence.
When type 1 (α) error was 5%, type 2 error (1-β) was 95%, and the effect size was accepted as 0.5, it was calculated that there should be at least 47 people in the groups.
Stratified and block randomization will be used to recruit patients into study groups.
The patients will be evaluated with the QUID test, risk assessment questionnaire in patients with stress urinary incontinence, incontinence short test, bladder diary, daily urinary incontinence, a notebook to record the duration of the exercises to be performed, quality of life scale and lifestyle changes questioning form.
The intervention group will be re-evaluated as a result of the intervention with measurement tools.
Intervention group: Brochure about incontinence will be given, web-based training will be applied, SMS will be sent every day according to the risks.
Control group: Only brochure will be given.
It is expected that a low-cost application to be developed after the study will reduce the complaints of the patients, increase their quality of life and have a positive effect on women's health.
It is difficult for physicians to allocate sufficient time to convey lifestyle changes and exercises to patients with stress urinary incontinence during their busy work hours in the clinic. After the success to be achieved, the usage rate of the website to be prepared will be increased through various scientific platforms and associations.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Group administered to individual telemedicine
- Keywords
- stress urinary incontinence, Kegel exercises, Randomization, Telemedicine
- 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.
Group administered to individual telemedicineOther
Also called Kegel and abdominal egsercises with telemedicine
A brochure containing incontinence patient information will be prepared and given, web-based training will be implemented, and informative/reminder messages will be sent via short messages every day.
| Study group | Role | What they receive |
|---|---|---|
| Traditional lifestyle changes and kegel exercise recommended group | No intervention | Patients with stress urinary incontinence will be given a brochure that will be prepared similar to the brochure given to the Intervention group. |
| Group administered to individual telemedicine | Active comparator | A brochure containing incontinence patient information will be prepared and given, web-based training will be implemented, and informative/reminder messages will be sent via short messages every day. Receives: Other: Group administered to individual telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telemedicine success
Changes in the "frequency of incontinence episodes patients" and "adaptation to lifestyle changes (Body mass index status, smoking, exercise, fluid intake) " in the intervention and control group after the study
Measured: 1 year
Quality of life score
Changes in the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) score. The questionnaire includes questions such as the frequency of urinary incontinence, the amount of leakage, its impact on daily lifestyle, and in what situation the patient leaks urine. The score that can be obtained from the scale is distributed between 0-21. As the total score decreases, the quality of life increases.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Jan 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Collaborators
- Eskisehir City Hospital
- Responsible party
- Principal investigator, SEVDA SUNGUR, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189443
- Sponsor's protocol ID
- EskisehirOU/03.03.2022-20
- Status last verified
- Dec 2023
- First submitted
- 9 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The information will not be shared as it falls under the personal data protection law.
Publications
Schroeder M, Plotner EA, Sharma S, Hunter K, Spector S, Lipetskaia L. A Randomized Controlled Trial of a Multimedia Patient Education Tool for Stress Versus Urgency Urinary Incontinence. Female Pelvic Med Reconstr Surg. 2021 Jul 1;27(7):403-408. doi: 10.1097/SPV.0000000000000946.
PubMed 32925421Rygh P, Asklund I, Samuelsson E. Real-world effectiveness of app-based treatment for urinary incontinence: a cohort study. BMJ Open. 2021 Jan 4;11(1):e040819. doi: 10.1136/bmjopen-2020-040819.
PubMed 33397664
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal-Kegel Exercise in Patients With Stress Urinary Incontinence and the Effect of Telemedicine Applications on Adaptation to Lifestyle Changes: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06189443
- Acronym / sponsor ID
- EskisehirOU/03.03.2022-20
- Conditions
- Stress Urinary Incontinence
- Keywords
- stress urinary incontinence, Kegel exercises, Randomization, Telemedicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Collaborators
- Eskisehir City Hospital
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 3 Jan 2024 (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.
Urinary incontinence is a very common health problem that reduces the quality of life mostly in women. Behavioral therapy (lifestyle changes, abdominal-Kegel exercises) is recommended as the first choice in the treatment of the disease. It is known that surgical and medical treatment cannot give a definite result. The application of behavioral therapy with telemedicine has advantages such as reducing the cost and increasing the treatment rate. In this study, it is aimed to evaluate the effect of telemedicine practices on compliance with multi-module behavioral therapy in women with stress urinary incontinence.
Detailed description
The study is a randomized controlled study to be conducted in female patients between the ages of 20-65 who applied to the Eskişehir City Hospital urology outpatient clinic and diagnosed with stress urinary incontinence.
When type 1 (α) error was 5%, type 2 error (1-β) was 95%, and the effect size was accepted as 0.5, it was calculated that there should be at least 47 people in the groups.
Stratified and block randomization will be used to recruit patients into study groups.
The patients will be evaluated with the QUID test, risk assessment questionnaire in patients with stress urinary incontinence, incontinence short test, bladder diary, daily urinary incontinence, a notebook to record the duration of the exercises to be performed, quality of life scale and lifestyle changes questioning form.
The intervention group will be re-evaluated as a result of the intervention with measurement tools.
Intervention group: Brochure about incontinence will be given, web-based training will be applied, SMS will be sent every day according to the risks.
Control group: Only brochure will be given.
It is expected that a low-cost application to be developed after the study will reduce the complaints of the patients, increase their quality of life and have a positive effect on women's health.
It is difficult for physicians to allocate sufficient time to convey lifestyle changes and exercises to patients with stress urinary incontinence during their busy work hours in the clinic. After the success to be achieved, the usage rate of the website to be prepared will be increased through various scientific platforms and associations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional lifestyle changes and kegel exercise recommended group | No intervention | –Patients with stress urinary incontinence will be given a brochure that will be prepared similar to the brochure given to the Intervention group. |
| Group administered to individual telemedicine | Active comparator | Other: Group administered to individual telemedicineA brochure containing incontinence patient information will be prepared and given, web-based training will be implemented, and informative/reminder messages will be sent via short messages every day. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- having symptoms of UI for at least the last 6 months,
- QUID stress score is ≥ 4,
- diagnosed with SUI as a result of the evaluation made by a specialist physician, have minimal skills in using new technologies
- Those who have the opportunity to access the web page to be prepared can participate in the research.
Key exclusion criteria (8 listed)
- History of using medical therapy for UI,
- existing urinary infection,
- diabetes mellitus,
- nervous system disease (such as multiple sclerosis, cerebrovascular disease),
- psychiatric illness or dementia,
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 |
|---|---|---|
| Group administered to individual telemedicineAlso: Kegel and abdominal egsercises with telemedicineA brochure containing incontinence patient information will be prepared and given, web-based training will be implemented, and informative/reminder messages will be sent via short messages every day. | Other | Group administered to individual telemedicine |
Primary outcome
Telemedicine success
Time frame: 1 year
Changes in the "frequency of incontinence episodes patients" and "adaptation to lifestyle changes (Body mass index status, smoking, exercise, fluid intake) " in the intervention and control group after the study
Quality of life score
Time frame: 1 year
Changes in the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) score. The questionnaire includes questions such as the frequency of urinary incontinence, the amount of leakage, its impact on daily lifestyle, and in what situation the patient leaks urine. The score that can be obtained from the scale is distributed between 0-21. As the total score decreases, the quality of life increases.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Background: PubMed 32925421Schroeder M, Plotner EA, Sharma S, Hunter K, Spector S, Lipetskaia L. A Randomized Controlled Trial of a Multimedia Patient Education Tool for Stress Versus Urgency Urinary Incontinence. Female Pelvic Med Reconstr Surg. 2021 Jul 1;27(7):403-408. doi: 10.1097/SPV.0000000000000946.
- Background: PubMed 33397664Rygh P, Asklund I, Samuelsson E. Real-world effectiveness of app-based treatment for urinary incontinence: a cohort study. BMJ Open. 2021 Jan 4;11(1):e040819. doi: 10.1136/bmjopen-2020-040819.
- Individual participant dataSharing planned: No. The information will not be shared as it falls under the personal data protection law.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group administered to individual telemedicine in people with Stress Urinary Incontinence, run by Eskisehir Osmangazi University at 2 sites in Turkey (Türkiye).
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 8 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 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
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?
Telemedicine success (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT06189443, which also lists 2 linked publications.
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 3 Jan 2024.