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N/A N=123 Randomized Treatment

Mobile App-treatment of Mixed and Urgency Urinary Incontinence in Women

Urinary Incontinence

Bottom Line

View on ClinicalTrials.gov: NCT03097549 ↗
Enrolled (actual)
123
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) — 7.0; 9.8 score on a scale — p=0.001

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Tät®II Information app (Device); Tät®II Treatment app (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Umeå University
Primary completion
Jul 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF)		 7.0; 9.8 0.001 sig
SECONDARY
International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ- LUTSqol).		 29.8; 36.5 0.004 sig
SECONDARY
Change From Baseline Incontinence Episode Frequency (IEF)		 3.5; 10.5 <0.001 sig
SECONDARY
International Consultation on Incontinence Modular Questionnaire Overactive Bladder (ICIQ-OAB)		 4.7; 6.4 <0.001 sig
SECONDARY
Incontinence Catastrophizing Scale (ICS)		 2.3; 4.1 0.016 sig
SECONDARY
Change From Baseline Usage of Incontinence Aids at 15 Weeks		 38; 25; 20; 38 0.01 sig
SECONDARY
Patient Global Impression of Improvement (PGI-I)		 52; 19; 8; 44 <0.001 sig
SECONDARY
Patient Satisfaction		 35; 13; 7 —

Summary

The purpose of this study is to determine whether a comprehensive treatment programme for self-management of mixed and urgency urinary incontinence via a mobile app is effective.

Eligibility Criteria

Inclusion Criteria

  • Urgency urinary incontinence or mixed urinary incontinence, established via telephone interview
  • Urinary leakage twice a week or more often
  • Duration of urinary leakage with urgency for at least 12 months
  • Ability to read and write Swedish
  • Asset to a smartphone (minimum iOS* 8.0 for Apple, 4.0.3 for Androids
  • Possibility to send and receive email and asset to printer
  • Motivation and time to perform a 15 weeks long treatment programme with focus on self-care and behavioural training (mainly pelvic floor muscle training and bladder training).
  • Accept to be randomized to one of two groups; a treatment app group or an information app Group
  • iOS=mobile operating system including iPhone, iPad and iPod touch

Exclusion Criteria

  • Participation in our previous internet or smartphone study
  • Ongoing pregnancy
  • Former incontinence surgery
  • Known malignancy in lower abdomen
  • Unassessed difficulties in emptying bladder
  • Visual blood in urine
  • Three or more urinary tract infections during the last 12 months
  • One or more pyelonephritis during the last three years
  • Painful micturition
  • Painful urgency
  • Intermenstrual bleeding
  • Neurological disease such as multiple sclerosis or Parkinsons disease
  • Previous stroke
  • Diabetes mellitus
  • Maximum voided volume of less than 150 ml (micturition chart)
  • Regular use of any mobile app for pelvic floor muscle training during the last month
  • Usage of antimuscarinic drugs or mirabegron during the last month
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03097549). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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