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

RCT comparing treatment based on a mobile application (App: URinControl) versus standard care in women with urinary incontinence in primary care.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25754

Enrollment

240

Registered

2015-01-22

Start date

2014-12-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary incontinence, Stress-incontinence, Urge-incontinence

Interventions

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, participant

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 t

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
The change in symptoms score, measured with the International consultation on Incontinence Questionnaire on UI Short Form (ICIQ-UI-SF), 4 months after randomization	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Contacts

Public ContactA.M.M. Loohuis

UMCG Afdeling huisartsgeneeskunde, FA21

a.m.m.loohuis@umcg.nlTel: +31 (0)50 3637232

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)