Treatment of Stress Urinary Incontinence Via Smartphone

This study has been completed.
Information provided by (Responsible Party):
Eva Samuelsson, Umeå University Identifier:
First received: April 26, 2013
Last updated: May 28, 2015
Last verified: May 2015
The purpose of this study is to determine whether treatment of stress urinary incontinence via smartphone is effective.

Condition Intervention
Female Stress Urinary Incontinence
Behavioral: Smartphone treatment with PFMT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Stress Urinary Incontinence Via Smartphone

Resource links provided by NLM:

Further study details as provided by Umeå University:

Primary Outcome Measures:
  • Change in the International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) [ Time Frame: three months ] [ Designated as safety issue: No ]
    Three items on frequency, amount of leakage and overall impact. Scoring 0-21, higher values indicating increasing severity

  • Change in the International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) [ Time Frame: three months ] [ Designated as safety issue: No ]
    The instrument includes 19 items on the impact of the leakage. All items are scored 1-4 (not at all/never, slightly/sometimes, moderately/often, a lot/all the time). The overall score is 19-76, with higher values indicating increased impact on QOL.

Secondary Outcome Measures:
  • Change in usage of Incontinence Aids [ Time Frame: Three months ] [ Designated as safety issue: No ]
  • Patient Satisfaction [ Time Frame: three months ] [ Designated as safety issue: No ]
  • Change in Incontinence Episode Frequency (IEF) [ Time Frame: three months ] [ Designated as safety issue: No ]
  • Patient`s Global Impression of Improvement Scale (PGI-I) [ Time Frame: three months ] [ Designated as safety issue: No ]

Enrollment: 123
Study Start Date: March 2013
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Smartphone treatment
Smartphone treatment with PFMT.
Behavioral: Smartphone treatment with PFMT
A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. The treatment period is three months
No Intervention: Waiting list
Waiting list for three months. They receive the smartphone application after follow-up.

  Show Detailed Description


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • stress urinary incontinence
  • leakage once a week or more often
  • duration of symptoms for at least 6 months
  • motivation and time to perform a 12 week long treatment with PMFT
  • ability to read and write Swedish
  • asset to smartphone
  • possibility to send and receive email and asset to printer
  • accept to be randomized to one of two groups; a treatment group or a waiting list group

Exclusion Criteria:

  • participation in our previous internet study
  • pregnancy
  • former incontinence surgery
  • known malignancy in lower abdomen
  • difficulties with passing urine
  • visual blood in urine
  • intermenstrual bleeding
  • severe psychiatric diagnosis
  • neurological disease with affection on sensibility in legs or lower abdomen
  • urge incontinence
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01848938

Umea University
Umeå, Sweden, S-90185
Sponsors and Collaborators
Umeå University
Study Chair: Eva Samuelsson, MD, PhD Department of Public Health and Clinical Medicine, Umeå University
  More Information

Responsible Party: Eva Samuelsson, Associate professor, General Practitioner, Umeå University Identifier: NCT01848938     History of Changes
Other Study ID Numbers: VisareNorr301811  JLL314561  FAS2008-0952  ALFVLL222081 
Study First Received: April 26, 2013
Last Updated: May 28, 2015
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Umeå University:
stress urinary incontinence
pelvic floor muscle training
life style

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations processed this record on May 23, 2016