Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06389838
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-04-25
Brief Title:
RCT on Multimodal Self-treatment for Women With Incontinence Using a Digital Health Application
Sponsor:
Kranus Health GmbH
Organization:
Kranus Health GmbH
Study Overview
Official Title:
Prospektiv Randomisierte Studie Zur Multimodalen Selbstbehandlung Von Frauen Mit Inkontinenzbeschwerden Mit Einer Digitalen Gesundheitsanwendung
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DINKS
Brief Summary:
This study titled Prospective Randomized Study on Multimodal Self-Treatment for Women with Incontinence Symptoms Using a Digital Health Application abbreviated as DINKS aims to investigate the efficacy of a digital health application in treating incontinence in women The study involves a single-center single blinded randomized controlled trial with two arms one receiving digital therapy intervention and the other serving as a control group with standard of care The primary objective is to reduce the frequency of incontinence episodes over a 12-week intervention period with secondary goals including improvements in disease symptoms quality of life and patient activation The study plans to recruit 198 female participants and assess various endpoints related to incontinence severity quality of life and treatment outcomes
Detailed Description:
The intervention in this study involves a digital therapy program delivered via a smartphone or tablet application This program includes several components aimed at addressing different aspects of incontinence management
Voiding Diary Participants will be instructed to maintain a diary to track their urinary habits including frequency of voiding episodes of incontinence and fluid intake
Pelvic Floor Exercises and Physiotherapy The digital therapy program will provide guidance on performing pelvic floor exercises and other physiotherapeutic interventions aimed at strengthening pelvic floor muscles and improving bladder control
Bladder Training and Cognitive Behavioral Therapy Participants will receive instructions on bladder training techniques and cognitive behavioral strategies to manage urgency and frequency of urination
Mental Exercises The program will include mental exercises such as mindfulness techniques progressive muscle relaxation and stimulus control methods to help participants manage stress anxiety and other psychological factors contributing to incontinence
Acute Urgency Management Strategies for managing acute episodes of urgency and urge incontinence will be provided including techniques to delay voiding and control bladder spasms
Educational and Nutritional Guidance Participants will have access to educational materials and nutritional guidance aimed at optimizing bladder health and overall well-being
Progress Tracking and Motivation The application will feature tools for tracking progress setting goals and providing motivational feedback to encourage adherence to the intervention
Overall the digital therapy program is designed to provide comprehensive support for women with incontinence symptoms addressing both physical and psychological aspects of the condition to improve symptom severity quality of life and patient activation
Voiding Diary Participants will be instructed to maintain a diary to track their urinary habits including frequency of voiding episodes of incontinence and fluid intake
Pelvic Floor Exercises and Physiotherapy The digital therapy program will provide guidance on performing pelvic floor exercises and other physiotherapeutic interventions aimed at strengthening pelvic floor muscles and improving bladder control
Bladder Training and Cognitive Behavioral Therapy Participants will receive instructions on bladder training techniques and cognitive behavioral strategies to manage urgency and frequency of urination
Mental Exercises The program will include mental exercises such as mindfulness techniques progressive muscle relaxation and stimulus control methods to help participants manage stress anxiety and other psychological factors contributing to incontinence
Acute Urgency Management Strategies for managing acute episodes of urgency and urge incontinence will be provided including techniques to delay voiding and control bladder spasms
Educational and Nutritional Guidance Participants will have access to educational materials and nutritional guidance aimed at optimizing bladder health and overall well-being
Progress Tracking and Motivation The application will feature tools for tracking progress setting goals and providing motivational feedback to encourage adherence to the intervention
Overall the digital therapy program is designed to provide comprehensive support for women with incontinence symptoms addressing both physical and psychological aspects of the condition to improve symptom severity quality of life and patient activation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-512094-27 | EUDRACT_NUMBER | DRKS | None |
| DRKS00033704 | REGISTRY | None | None |