Stress Urinary IncontinenceNCT06241378
FEASIBILITY STUDY OF TELE-REHABILITATION IN WOMEN WITH STRESS URINARY INCONTINENCE
An observational study of Stress Urinary Incontinence, run by Cairo University at 1 site in Egypt.
Trial summary
Tele-rehabilitation involves health care services, support and information provided remotely via digital communication and devices. It intends to facilitate effective delivery of health services such as physical therapy by improving access to care and information and managing health care resources. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- perineometer device for physiotherapy
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Jan 2024to 30 Jun 2024
- Phase
- Observational
- 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 18 to 65 years
- Women only
- Adult, Older adult
Study population: Females complaining of stress urinary incontinence for at least once per week. - An age range of 20-65 years.
Who may be able to join
- - Females complaining of stress urinary incontinence for at least once per week.
- An age range of 20-65 years.
- Being able to read and write.
- Primiparous or multiparous women.
- Being able to use the Internet, phone services, and online platforms.
Who cannot join
- Patients will be excluded if they have: - - Pregnancy.
- Previous surgery for treating SUI.
- Malignancy in the lower abdomen/ pelvis.
- Any psychiatric disorder that may affect the cognitive function
- Neurological disease with affected sensation of the legs or lower abdomen
- Neurogenic bladder.
Trial locations and contacts
1 site in 1 country.
About this study
Tele-rehabilitation involves health care services, support and information provided remotely via digital communication and devices. It intends to facilitate effective delivery of health services such as physical therapy by improving access to care and information and managing health care resources. Other terms such as telehealth, telemonitoring, tele-rehabilitation, tele-education and tele-assistance describe digital practice. Due to the pandemic caused by coronavirus disease 2019 (COVID-19), health associations worldwide have released recommendations about care from distance using tools of communication and information technologies
Read the detailed description
The female pelvic floor serves multiple functions: pleasure and sexuality, parturition, urination and urinary continence, defecation and fecal continence, and keeping the pelvic organs in position. To perform its functions, the pelvic floor needs an intact anatomical structure, consisting of muscle, connective tissue, and nerves. Moreover, its function is subject to control by the central nervous system. Pelvic floor function and continence can thus be impaired not only by direct anatomical injury, as in vaginal delivery, but also by dysfunctional neural control, e.g., in neurologic disease, diabetic neuropathy, and cognitive disorders (lange, 2007).
The percentage of women suffering from pelvic floor dysfunction (PFD) ranges from 30% to 50%, the main types of female pelvic floor dysfunction involve urinary and/or fecal incontinence and prolapse of the female reproductive organs. Pregnancy and delivery are an important risk factor for urinary incontinence (jundt et al., 2015).
One of the most problems of pelvic floor dysfunction is stress urinary incontinence (SUI), (SUI) defined as the involuntary, sudden loss of urine secondary to increased intra-abdominal pressure that is bothersome or affecting the patient's quality of life. Physical activities precipitating SUI include laughing, sneezing, straining, coughing, or exercising. Patients may refer to a sudden loss of urine as "leaking," "dripping" or "flooding." The patient may initially present with urinary complaints of frequency, urgency, and dysuria. SUI affects 15.7% of adult women; 77.5% of women report the symptoms to be bothersome and 28.8% report the symptoms to be moderate to severe. Prevalence of SUI increases with age, particularly with menopause (Nygaard et al., 2008).
Stress urinary incontinence can exert a significant impact on a patient's life. Treatment aims at improving the quality of life. Complete resolution of SUI may not be feasible, and a combination of behavioral, pharmacological, and surgical treatment may be necessary. Some patients may be satisfied with improved SUI without complete resolution especially if it avoids surgery.
Tele-rehabilitation involves health care services, support and information provided remotely via digital communication and devices. It intends to facilitate effective delivery of health services such as physical therapy by improving access to care and information and managing health care resources. Other terms such as telehealth, telemonitoring, tele-rehabilitation, tele-education and tele-assistance describe digital practice. Due to the pandemic caused by coronavirus disease 2019 (COVID-19), health associations worldwide have released recommendations about care from distance using tools of communication and information technologies (Dantas et al., 2020).
Although the panadeimic has been decreased, with, tele-rehabilitation. The patient don't have to drive to the doctor's office or clinic, park, walk or sit in a waiting room when he is sick. Everyone can see his doctor from the comfort of his own bed or sofa. Virtual visits can be easier to fit into a busy schedule. With, telerehabilitation. Depending on the patient schedule, NO one will have to take time from work or arrange for child care.
Research question:
This study was done to answer the following question: was it feasible to assess stress urinary incontinence through tele-rehabilitation.
- Conditions
- Stress Urinary Incontinence
- Being tested
- perineometer device for physiotherapy
- Keywords
- tele-rehabilitation 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.
perineometer device for physiotherapyDevice
measuring the vaginal pressure for stress urinary incontinence patients
| Study group | Role | What they receive |
|---|---|---|
| patient with stress urinary incontinence | * A hundred twenty-three female with SUI at least once/ week
* Patients were recruited from Kasr Al Aieny women's health outpatient clinic, Giza, Egypt.
* Females with an age range 18-65years.
* Being able to read and write
* Being able to use Internet and phone services.
* All of patients with no history of other neurological manifestation.
* Primiparous and multiparous women. Receives: Device: perineometer device for physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the efficacy of tele-rehabilitation in stress urinary incontinence patients
This study will be carried out to investigate the feasibility of assessing stress urinary incontinence through tele-rehabilitation.
Measured: basline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start27 Jan 2024 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion30 Jun 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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnya Ahmed Edrees, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241378
- Sponsor's protocol ID
- TELE-REHABILITATION
- Status last verified
- Jan 2024
- First submitted
- 27 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abe-Takahashi Y, Kitta T, Ouchi M, Okayauchi M, Chiba H, Higuchi M, Togo M, Shinohara N. Reliability and validity of pelvic floor muscle strength assessment using the MizCure perineometer. BMC Womens Health. 2020 Nov 19;20(1):257. doi: 10.1186/s12905-020-01127-x.
PubMed 33213429da Mata KRU, Costa RCM, Carbone EDSM, Gimenez MM, Bortolini MAT, Castro RA, Fitz FF. Telehealth in the rehabilitation of female pelvic floor dysfunction: a systematic literature review. Int Urogynecol J. 2021 Feb;32(2):249-259. doi: 10.1007/s00192-020-04588-8. Epub 2020 Nov 11.
PubMed 33175229
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FEASIBILITY STUDY OF TELE-REHABILITATION IN WOMEN WITH STRESS URINARY INCONTINENCE
- ClinicalTrials.gov ID
- NCT06241378
- Acronym / sponsor ID
- TELE-REHABILITATION
- Conditions
- Stress Urinary Incontinence
- Keywords
- tele-rehabilitation stress urinary incontinence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 27 Jan 2024 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 5 Feb 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.
Tele-rehabilitation involves health care services, support and information provided remotely via digital communication and devices. It intends to facilitate effective delivery of health services such as physical therapy by improving access to care and information and managing health care resources. Other terms such as telehealth, telemonitoring, tele-rehabilitation, tele-education and tele-assistance describe digital practice. Due to the pandemic caused by coronavirus disease 2019 (COVID-19), health associations worldwide have released recommendations about care from distance using tools of communication and information technologies
Detailed description
The female pelvic floor serves multiple functions: pleasure and sexuality, parturition, urination and urinary continence, defecation and fecal continence, and keeping the pelvic organs in position. To perform its functions, the pelvic floor needs an intact anatomical structure, consisting of muscle, connective tissue, and nerves. Moreover, its function is subject to control by the central nervous system. Pelvic floor function and continence can thus be impaired not only by direct anatomical injury, as in vaginal delivery, but also by dysfunctional neural control, e.g., in neurologic disease, diabetic neuropathy, and cognitive disorders (lange, 2007).
The percentage of women suffering from pelvic floor dysfunction (PFD) ranges from 30% to 50%, the main types of female pelvic floor dysfunction involve urinary and/or fecal incontinence and prolapse of the female reproductive organs. Pregnancy and delivery are an important risk factor for urinary incontinence (jundt et al., 2015).
One of the most problems of pelvic floor dysfunction is stress urinary incontinence (SUI), (SUI) defined as the involuntary, sudden loss of urine secondary to increased intra-abdominal pressure that is bothersome or affecting the patient's quality of life. Physical activities precipitating SUI include laughing, sneezing, straining, coughing, or exercising. Patients may refer to a sudden loss of urine as "leaking," "dripping" or "flooding." The patient may initially present with urinary complaints of frequency, urgency, and dysuria. SUI affects 15.7% of adult women; 77.5% of women report the symptoms to be bothersome and 28.8% report the symptoms to be moderate to severe. Prevalence of SUI increases with age, particularly with menopause (Nygaard et al., 2008).
Stress urinary incontinence can exert a significant impact on a patient's life. Treatment aims at improving the quality of life. Complete resolution of SUI may not be feasible, and a combination of behavioral, pharmacological, and surgical treatment may be necessary. Some patients may be satisfied with improved SUI without complete resolution especially if it avoids surgery.
Tele-rehabilitation involves health care services, support and information provided remotely via digital communication and devices. It intends to facilitate effective delivery of health services such as physical therapy by improving access to care and information and managing health care resources. Other terms such as telehealth, telemonitoring, tele-rehabilitation, tele-education and tele-assistance describe digital practice. Due to the pandemic caused by coronavirus disease 2019 (COVID-19), health associations worldwide have released recommendations about care from distance using tools of communication and information technologies (Dantas et al., 2020).
Although the panadeimic has been decreased, with, tele-rehabilitation. The patient don't have to drive to the doctor's office or clinic, park, walk or sit in a waiting room when he is sick. Everyone can see his doctor from the comfort of his own bed or sofa. Virtual visits can be easier to fit into a busy schedule. With, telerehabilitation. Depending on the patient schedule, NO one will have to take time from work or arrange for child care.
Research question:
This study was done to answer the following question: was it feasible to assess stress urinary incontinence through tele-rehabilitation.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with stress urinary incontinence | – | Device: perineometer device for physiotherapy* A hundred twenty-three female with SUI at least once/ week * Patients were recruited from Kasr Al Aieny women's health outpatient clinic, Giza, Egypt. * Females with an age range 18-65years. * Being able to read and write * Being able to use Internet and phone services. * All of patients with no history of other neurological manifestation. * Primiparous and multiparous women. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Females complaining of stress urinary incontinence for at least once per week. - An age range of 20-65 years.
Key inclusion criteria (5 listed)
- - Females complaining of stress urinary incontinence for at least once per week.
- An age range of 20-65 years.
- Being able to read and write.
- Primiparous or multiparous women.
- Being able to use the Internet, phone services, and online platforms.
Key exclusion criteria (6 listed)
- Patients will be excluded if they have: - - Pregnancy.
- Previous surgery for treating SUI.
- Malignancy in the lower abdomen/ pelvis.
- Any psychiatric disorder that may affect the cognitive function
- Neurological disease with affected sensation of the legs or lower abdomen
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 |
|---|---|---|
| perineometer device for physiotherapymeasuring the vaginal pressure for stress urinary incontinence patients | Device | patient with stress urinary incontinence |
Primary outcome
the efficacy of tele-rehabilitation in stress urinary incontinence patients
Time frame: basline
This study will be carried out to investigate the feasibility of assessing stress urinary incontinence through tele-rehabilitation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Background: PubMed 33213429Abe-Takahashi Y, Kitta T, Ouchi M, Okayauchi M, Chiba H, Higuchi M, Togo M, Shinohara N. Reliability and validity of pelvic floor muscle strength assessment using the MizCure perineometer. BMC Womens Health. 2020 Nov 19;20(1):257. doi: 10.1186/s12905-020-01127-x.
- Background: PubMed 33175229da Mata KRU, Costa RCM, Carbone EDSM, Gimenez MM, Bortolini MAT, Castro RA, Fitz FF. Telehealth in the rehabilitation of female pelvic floor dysfunction: a systematic literature review. Int Urogynecol J. 2021 Feb;32(2):249-259. doi: 10.1007/s00192-020-04588-8. Epub 2020 Nov 11.
- Related InfoLink provided by the sponsor.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence, 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 5 inclusion and 6 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 5 Feb 2024. 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 omnya Edrees, bachelor (0201060307452, dr.edresoo222@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the efficacy of tele-rehabilitation in stress urinary incontinence patients (time frame: basline). 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 NCT06241378, 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 5 Feb 2024.