Clinical trial NCT06241378: FEASIBILITY STUDY OF TELE-REHABILITATION IN WOMEN WITH STRESS URINARY INCONTINENCE
Official title: FEASIBILITY STUDY OF TELE-REHABILITATION IN WOMEN WITH STRESS URINARY INCONTINENCE
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stress Urinary Incontinence
Keywords: tele-rehabilitation stress urinary incontinence
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Females complaining of stress urinary incontinence for at least once per week.

- An age range of 20-65 years.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* - 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.

Exclusion Criteria:

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.

Primary outcomes:
measure: the efficacy of tele-rehabilitation in stress urinary incontinence patients
timeFrame: basline
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: CU
state: Giza
Study officials:
References:
citation: 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.
citation: 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.