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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

omnya Edrees, bachelor contact

0201060307452

dr.edresoo222@gmail.com

Egypt1 site, 1 recruiting
  • CU

    Cairo, Giza Governorate, 12613

    Recruiting

Other trials in Egypt

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.

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 groups in NCT06241378
Study groupRoleWhat 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.

  1. 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.

  1. First posted5 Feb 2024
  2. Study start27 Jan 2024 (estimated)
  3. Primary completion31 May 2024 (estimated)
  4. Study completion30 Jun 2024 (estimated)

Resources

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)
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 33213429
  • da 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

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.

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