A 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.
ID
Bron
Verkorte titel
Aandoening
Urinary incontinence, Stress-incontinence, Urge-incontinence
Ondersteuning
University Medical Centre Groningen
University of Groningen
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The change in symptoms score, measured with the International consultation on Incontinence Questionnaire on UI Short Form (ICIQ-UI-SF), 4 months after randomization
Achtergrond van het onderzoek
BACKGROUND 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.
Doel van het onderzoek
A 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.
Onderzoeksopzet
Three assessments will be performed, at baseline, after 4 months and after 12 months.
Onderzoeksproduct en/of interventie
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.
Publiek
A.M.M. Loohuis
Antonius Deusinglaan 1, Postbus 196
Groningen 9700 AD
The Netherlands
Tel: +31 (0)50 3637232
a.m.m.loohuis@umcg.nl
Wetenschappelijk
A.M.M. Loohuis
Antonius Deusinglaan 1, Postbus 196
Groningen 9700 AD
The Netherlands
Tel: +31 (0)50 3637232
a.m.m.loohuis@umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Subject 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL4948 |
NTR-old | NTR5052 |
Ander register | - : Protocol ID 837001508 |
Samenvatting resultaten
Van der Worp H, Loohuis AMM, Flohil I, Kollen BJ, Wessels NJ, Blanker MH. Recruitment through media and general practitioners resulted in comparable samples in an RCT on incontinence. Journal of Clinical Epidemiology (online first: https://doi.org/10.1016/j.jclinepi.2019.12.001)