FEASIBILITY STUDY OF TELE-REHABILITATION IN WOMEN WITH STRESS URINARY INCONTINENCE

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

Study Overview

• Status: Recruiting
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: perineometer device for physiotherapy

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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: omnya Edrees, bachelor; Phone Number: 0201060307452; Email: dr.edresoo222@gmail.com

Study Locations

• Egypt
  • Giza
    • Cairo, Giza, Egypt, 12613
      • Recruiting
      • CU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Device: perineometer device for physiotherapy; measuring the vaginal pressure for stress urinary incontinence patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	basline

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): January 27, 2024
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: January 27, 2024
• First Submitted That Met QC Criteria: January 27, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Actual): February 5, 2024
• Last Update Submitted That Met QC Criteria: January 27, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: tele-rehabilitation stress urinary incontinence
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: TELE-REHABILITATION

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No