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Treatment of Stress Urinary Incontinence Via Smartphone

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ClinicalTrials.gov Identifier: NCT01848938
Recruitment Status : Completed
First Posted : May 8, 2013
Results First Posted : December 9, 2016
Last Update Posted : April 5, 2017
Information provided by (Responsible Party):
Eva Samuelsson, Umeå University

Brief Summary:
The purpose of this study is to determine whether treatment of stress urinary incontinence (SUI) via smartphone is effective.

Condition or disease Intervention/treatment Phase
Female Stress Urinary Incontinence Behavioral: Smartphone treatment with PFMT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Stress Urinary Incontinence Via Smartphone
Study Start Date : March 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) [ Time Frame: baseline, three months ]
    Three items on frequency, amount of leakage and overall impact. Scoring 0-21, higher values indicating increasing severity

  2. International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) [ Time Frame: baseline, three months ]
    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 :
  1. Usage of Incontinence Aids [ Time Frame: three months ]
    Usage of incontinence aids during the last 4 weeks.

  2. Patient Satisfaction [ Time Frame: three months ]
    A self-rated question about if the current treatment was sufficient, with three response options

  3. Incontinence Episode Frequency (IEF) [ Time Frame: baseline, three months ]
    number of incontinence episodes per week

  4. Patient's Global Impression of Improvement Scale (PGI-I) [ Time Frame: three months ]
    A self-rated question that asks about the change experienced after treatment with 7 response options, ranging from "very much better" to "very much worse".

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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 pelvic floor muscle training
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848938

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Umea University
Umeå, Sweden, S-90185
Sponsors and Collaborators
Umeå University
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Study Chair: Eva Samuelsson, MD, PhD Department of Public Health and Clinical Medicine, Umeå University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eva Samuelsson, Associate professor, General Practitioner, Umeå University
ClinicalTrials.gov Identifier: NCT01848938    
Other Study ID Numbers: VisareNorr301811
JLL314561 ( Other Grant/Funding Number: The County council of Jämtland )
FAS2008-0952 ( Other Grant/Funding Number: Swedish Council for Working Life and Social research )
ALFVLL222081 ( Other Grant/Funding Number: Västerbotten County Council (ALF) )
First Posted: May 8, 2013    Key Record Dates
Results First Posted: December 9, 2016
Last Update Posted: April 5, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Eva Samuelsson, Umeå University:
stress urinary incontinence
pelvic floor muscle training
life style
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders