NCT03097549

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

April 3, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2018

Completed
6.4 years until next milestone

Results Posted

Study results publicly available

February 19, 2025

Completed
Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

1.3 years

First QC Date

March 20, 2017

Results QC Date

February 8, 2022

Last Update Submit

February 18, 2025

Conditions

Urinary Incontinence

Keywords

urinary incontinenceurgency urinary incontinencemixed urinary incontinencesmartphone applicationehealthmhealthrandomized controlled trialself managementtreatment

Outcome Measures

Primary Outcomes (1)

  • International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF)

    Three items on frequency, amount of leakage and overall impact. Scoring 0-21, higher values indicating increasing severity.

    15 weeks

Secondary Outcomes (7)

  • International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ- LUTSqol).

    15 weeks

  • Change From Baseline Incontinence Episode Frequency (IEF)

    15 weeks

  • International Consultation on Incontinence Modular Questionnaire Overactive Bladder (ICIQ-OAB)

    15 weeks

  • Incontinence Catastrophizing Scale (ICS)

    15 weeks

  • Change From Baseline Usage of Incontinence Aids at 15 Weeks

    15 weeks

  • +2 more secondary outcomes

Study Arms (2)

Tät®II Treatment app

EXPERIMENTAL

Comprehensive treatment programme with information and exercises. Individual advices.

Device: Tät®II Treatment app

Tät®II Information app

OTHER

Information only. .

Device: Tät®II Information app

Interventions

Tät®II Information appDEVICE

Information about pelvic floor muscle training and bladder training for urgency and mixed urinary incontinence. Information about psychological factors and life style factors that might interfere with incontinence.

Also known as: Mobile application Tät®II with information only
Tät®II Information app
Tät®II Treatment appDEVICE

Information about pelvic floor muscle training and bladder training for urgency and mixed urinary incontinence. Information about psychological factors and life style factors that might interfere with incontinence .Exercises for the pelvic floor muscles, for bladder training, and for behaviours of avoidance due to fear of leakage, a statistic function and possibility to set reminders. Individual advices regarding life style factors and training based on findings from the bladder diary and answers in the questionnaires.

Also known as: Mobile application Tät®II with treatment programme
Tät®II Treatment app

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umea University

Umeå, S-90185, Sweden

Location

Related Publications (10)

  • Hannestad YS, Rortveit G, Sandvik H, Hunskaar S; Norwegian EPINCONT study. Epidemiology of Incontinence in the County of Nord-Trondelag. A community-based epidemiological survey of female urinary incontinence: the Norwegian EPINCONT study. Epidemiology of Incontinence in the County of Nord-Trondelag. J Clin Epidemiol. 2000 Nov;53(11):1150-7. doi: 10.1016/s0895-4356(00)00232-8.

    PMID: 11106889BACKGROUND

  • Siddiqui NY, Levin PJ, Phadtare A, Pietrobon R, Ammarell N. Perceptions about female urinary incontinence: a systematic review. Int Urogynecol J. 2014 Jul;25(7):863-71. doi: 10.1007/s00192-013-2276-7. Epub 2013 Dec 6.

    PMID: 24310988BACKGROUND

  • Shamliyan T, Wyman J, Kane RL. Nonsurgical Treatments for Urinary Incontinence in Adult Women: Diagnosis and Comparative Effectiveness [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Apr. Report No.: 11(12)-EHC074-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK92960/

    PMID: 22624162BACKGROUND

  • Dumoulin C, Hunter KF, Moore K, Bradley CS, Burgio KL, Hagen S, Imamura M, Thakar R, Williams K, Chambers T. Conservative management for female urinary incontinence and pelvic organ prolapse review 2013: Summary of the 5th International Consultation on Incontinence. Neurourol Urodyn. 2016 Jan;35(1):15-20. doi: 10.1002/nau.22677. Epub 2014 Nov 15.

    PMID: 25400065BACKGROUND

  • Garley A, Unwin J. A case series to pilot cognitive behaviour therapy for women with urinary incontinence. Br J Health Psychol. 2006 Sep;11(Pt 3):373-86. doi: 10.1348/135910705X53876.

    PMID: 16870050BACKGROUND

  • Asklund I, Nystrom E, Sjostrom M, Umefjord G, Stenlund H, Samuelsson E. Mobile app for treatment of stress urinary incontinence: A randomized controlled trial. Neurourol Urodyn. 2017 Jun;36(5):1369-1376. doi: 10.1002/nau.23116. Epub 2016 Sep 9.

    PMID: 27611958BACKGROUND

  • Whitehead L, Seaton P. The Effectiveness of Self-Management Mobile Phone and Tablet Apps in Long-term Condition Management: A Systematic Review. J Med Internet Res. 2016 May 16;18(5):e97. doi: 10.2196/jmir.4883.

    PMID: 27185295BACKGROUND

  • Albers-Heitner PC, Lagro-Janssen TA, Joore MM, Berghmans BL, Nieman FF, Venema PP, Severens JJ, Winkens RR. Effectiveness of involving a nurse specialist for patients with urinary incontinence in primary care: results of a pragmatic multicentre randomised controlled trial. Int J Clin Pract. 2011 Jun;65(6):705-12. doi: 10.1111/j.1742-1241.2011.02652.x.

    PMID: 21564445BACKGROUND

  • Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2.

    PMID: 37811598DERIVED

  • Wadensten T, Nystrom E, Franzen K, Lindam A, Wasteson E, Samuelsson E. A Mobile App for Self-management of Urgency and Mixed Urinary Incontinence in Women: Randomized Controlled Trial. J Med Internet Res. 2021 Apr 5;23(4):e19439. doi: 10.2196/19439.

    PMID: 33818395DERIVED

Related Links

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Towe Wadensten
Organization
Umeå University
towe.wadensten@umu.se
0046907865000

Study Officials

  • Eva C Samuelsson, MD, PhD

    Department of public health and clinical medicine, Umeå university, Umeå, Sweden

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, MD, PhD, General Practitioner

Study Record Dates

First Submitted

March 20, 2017

First Posted

March 31, 2017

Study Start

April 3, 2017

Primary Completion

July 27, 2018

Study Completion

September 19, 2018

Last Updated

February 19, 2025

Results First Posted

February 19, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)