Treatment of Stress Urinary Incontinence Via Smartphone
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01848938 |
Recruitment Status :
Completed
First Posted : May 8, 2013
Results First Posted : December 9, 2016
Last Update Posted : April 5, 2017
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Condition or disease | Intervention/treatment | Phase |
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Female Stress Urinary Incontinence | Behavioral: Smartphone treatment with PFMT | Not Applicable |

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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Smartphone treatment
Smartphone treatment with PFMT.
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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.
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- 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
- 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.
- Usage of Incontinence Aids [ Time Frame: three months ]Usage of incontinence aids during the last 4 weeks.
- Patient Satisfaction [ Time Frame: three months ]A self-rated question about if the current treatment was sufficient, with three response options
- Incontinence Episode Frequency (IEF) [ Time Frame: baseline, three months ]number of incontinence episodes per week
- 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".

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, Learn About Clinical Studies.
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

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
Sweden | |
Umea University | |
Umeå, Sweden, S-90185 |
Study Chair: | Eva Samuelsson, MD, PhD | Department of Public Health and Clinical Medicine, Umeå University |
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 |
female stress urinary incontinence treatment pelvic floor muscle training |
smartphone internet life style eHealth |
Urinary Incontinence Enuresis Urinary Incontinence, Stress Urination Disorders Urologic Diseases |
Lower Urinary Tract Symptoms Urological Manifestations Behavioral Symptoms Elimination Disorders Mental Disorders |