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Randomized controlled trial in adult women with urinary incontinence comparing treatment delivered through a mobile application versus standard care.


- candidate number21609
- NTR NumberNTR5052
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-jan-2015
- Secondary IDsProtocol ID 837001508 
- Public TitleRandomized controlled trial in adult women with urinary incontinence comparing treatment delivered through a mobile application versus standard care.
- Scientific TitleRCT comparing treatment based on a mobile application (App: URinControl) versus standard care in women with urinary incontinence in primary care.
- ACRONYMURinControl
- hypothesisA treatment program for urinary incontinence (UI) in adult women delivered through a mobile application is not inferior to the standard way of treating patients, in primary care regarding its effects, it is less expensive and more cost-effective.
- Healt Condition(s) or Problem(s) studiedUrinary incontinence, Stress urinary incontinence, Urge incontinence
- Inclusion criteriaSubject must meet all of the following criteria:
- Women, 18 years or older;
- Access to mobile Apps (iOS or Android);
- Urinary incontinence (UI), defined as any involuntary loss of urine according to the definition of the international Consultation on Incontinence (ICI), regardless of subtype (stress-, urgency- or mixed type UI). Incontinence episodes should be twice a week or more;
- Wish to be treated;
- Written informed consent.
- Exclusion criteriaPotential participant who meets any of the following criteria will be excluded from study:
- Indwelling urinary catheter;
- Urogenital malignancy;
- Previous urethral surgery;
- Being treated for UI in the previous year (pharmacologically or non-pharmacologically);
- Terminally or seriously ill;
- Cognitive impairment or psychiatric disorder;
- Urinary tract infection;
- Overflow or continuous UI;
- Pregnancy or recent childbirth (< 6 months ago);
- Inability to complete a questionnaire in Dutch.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2014
- planned closingdate1-dec-2019
- Target number of participants240
- InterventionsIntervention group: Mobile application (App)
After randomization patients will receive access to the App- URinControl. In the App, basic information is provided in a video fragment. Next, participants will be guided for type of UI and starting level of exercises and start with a tailored training program. Women with stress (predominant) UI will start with pelvic floor muscle training (PFMT); women with urgency (predominant) UI will start with bladder training and PFMT will be added later in the program. All exercises will be supported by audio fragments. All information will be available through a bibliography within the app.
During the program patients are asked to fill out the number of incontinence episodes, as well as the intensity with which they performed the exercises. Treatment will be reinforced by regularly sending 'push' notifications to stimulate treatment adherence.
The content of the app is a translation of the recommendations of the guidelines on the treatment of UI of women in primary care. If the progress of the treatment is unsatisfactory participants are advised to contact their general practitioner (GP).

Control group: Standard Care
Patients in the standard care group will be diagnosed and treated according to NHG-guideline on UI (PFMT in case of stress UI, bladder training for urgency UI). GP’s can instruct patients themselves, or refer them to a practice nurse or a specialized pelvic physiotherapist.
- Primary outcomeThe change in symptoms score, measured with the International consultation on Incontinence Questionnaire on UI Short Form (ICIQ-UI-SF), 4 months after randomization
- Secondary outcomeAll secondary endpoints are assessed 4 and 12 months after randomization.
- Patient-reported Global Impression of Improvement;
- Condition-specific quality of life;
- Generic health related quality of life;
- Numer of incontinence episodes per day
- Costs at one year
- TimepointsThree assessments will be performed, at baseline, after 4 months and after 12 months.
- Trial web sitewww.urincontrol.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. A.M.M. Loohuis
- CONTACT for SCIENTIFIC QUERIESMD, PhD M.H. Blanker
- Sponsor/Initiator University Medical Center Groningen (UMCG), Department of General Practice
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryBACKGROUND Urinary incontinence (UI) is a highly prevalent disorder in women. Despite available treatment options only 30% of women seek help for the problem. The availability of an easy-to-use, evidence based App for the treatment of UI may reduce the necessity of face-to-face contacts and increase continence rates and quality of life. Especially, the possibility to receive frequent reminders would enable patients to perform the necessary training, as forgetting is the most important reason why adherence can be lacking. This will help women with UI to have a better quality of life and it will considerably reduce health care costs.

OBJECTIVE To study the effects and cost-effectiveness of a App-based treatment program for women with urinary incontinence (UI) compared to standard care delivered by the general practitioner.

STUDY DESIGN AND POPULATION: Randomized controlled trial with non-inferiority design with non-pregnant women aged 18 years or older, who visit their general practitioner (GP) for symptoms of UI are eligible. They will be recruited from general practices in the northern part of the Netherlands.

INTERVENTION: The intervention consists of a treatment program on a mobile application for tablet or smartphone without face-to-face contact (App URinControl). The active control treatment is the standard care delivered by the GP

OUTCOME MEASURES: The primary outcome is the score on the International consultation on Incontinence Questionnaire on UI Short Form (ICIQ-UI-SF), which measures symptoms and impact of the UI on daily life. Secondary outcomes are the perception of improvement by the patient, number of UI episodes, condition- specific and generic health related quality of life sexual functioning and costs. Also, a process evaluation will take place.
- Main changes (audit trail)18-okt-2015:

Exclusion critaria NEW:
Potential participant who meets any of the following criteria will be excluded from study:
- Indwelling urinary catheter;
- Urogenital malignancy;
- Previous urethral surgery for incontinence or prolapse;
- Being treated for UI in the previous year (pharmacologically or non-pharmacologically);
- Terminally or seriously ill;
- Cognitive impairment or psychiatric disorder;
- Urinary tract infection;
- Overflow or continuous UI;
- Pregnancy or recent childbirth (< 6 months ago);
- Inability to complete a questionnaire in Dutch.
- Prolapse POPQ ≥ stage IIb

Intervention NEW:
Intervention group: Mobile application (App) After randomization patients will receive access to the URinControl-App. In the App, basic information is provided in a video fragment. Next, participants will learn how to use their pelvic floor. Then the participants will start with a training program tailored to their type of incontinence. Women with stress (predominant) UI will start with pelvic floor muscle training (PFMT); women with urgency (predominant) UI will start with bladder training and PFMT will be added later in the program. All exercises will be supported by animations. All information will be available through a bibliography within the app. During the program patients are asked to fill out the number of incontinence episodes, as well as the intensity with which they performed the exercises. Treatment will be reinforced by regularly sending 'push' notifications to stimulate treatment adherence.  The content of the app is a translation of the recommendations of the guidelines on the treatment of UI of women in primary care. In the letter with instructions which will be advised to contact their general practitioner (GP) if the progress of the treatment is unsatisfactory.

Control group: Standard Care  Patients in the standard care group will be diagnosed and treated according to NHG-guideline on UI (PFMT in case of stress UI, bladder training and PFMT for urgency UI). GP’s can instruct patients themselves, or refer them to a practice nurse or a specialized pelvic physiotherapist. In case of urgency incontinence, they can also choose to prescribe medication.

Secondary outcome NEW:
All secondary endpoints are assessed 4 and 12 months after randomization.
- Patient-reported Global Impression of Improvement;
- Condition-specific quality of life;
- Generic health related quality of life;
- Number of incontinence episodes per day
- Sexual functioning
- frequency, severity and impact of incontinence (every month during first 4 months)
- Costs at 12 months
- Process evaluation: Evaluation of user friendliness and acceptability of patients and health-care workers.

- RECORD22-jan-2015 - 18-okt-2015


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