NCT06189443

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 3, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

January 3, 2024

Status Verified

December 1, 2023

Enrollment Period

1.2 years

First QC Date

December 9, 2023

Last Update Submit

December 19, 2023

Conditions

Keywords

stress urinary incontinenceKegel exercisesRandomizationTelemedicine

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    1 year

Study Arms (2)

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.

Other: Group administered to individual telemedicine

Interventions

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.

Also known as: Kegel and abdominal egsercises with telemedicine
Group administered to individual telemedicine

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsstress urinary incontinence is common in women than men
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Eskisehir Osmangazi University Faculty of Medicine

Eskişehir, Tepebaşı, 26000, Turkey (Türkiye)

Location

Eskişehir Osmangazi Üniversitesi Tıp Fakültesi

Eskişehir, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 32925421BACKGROUND
  • Rygh 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.

    PMID: 33397664BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

December 9, 2023

First Posted

January 3, 2024

Study Start

January 1, 2023

Primary Completion

March 31, 2024

Study Completion

July 30, 2024

Last Updated

January 3, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

The information will not be shared as it falls under the personal data protection law.

Locations