Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 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) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether treatment of stress urinary incontinence (SUI) via smartphone is effective.
Female urinary incontinence (UI) is very common and affects up to one fourth of grownup women. It may reduce quality of life for those affected and costs for society are high. The most common type of urinary incontinence is SUI, i.e leakage when coughing, sneezing or jumping.
The recommended first line treatment is pelvic floor muscle training (PFMT)which leads to improvement or cure in two-thirds of patients. In addition, life style changes, such as weight loss when obese, smoking cessation and reduction of fluid intake if high is recommended.
There is a need for new , flexible and easily accessible treatment programmes for female urinary incontinence. In our previous study, we compared two treatment programmes for SUI without face-to-face contact: one internet based and one sent by post, both based on three months of PFMT. In this randomized controlled trial of 250 women aged 18-70 years, we found highly significant improvements (p<0.001) with large effect sizes (>0,8)concerning primary outcomes (symptoms and quality of life scores) but no significant differences between groups. Compared with the postal group, more participants in the internet group perceived they were much or very much improved (40.9% vs 26.5%, p<0.01, reported reduced usage of incontinence aids (59.5% vs 41.4%, p=0.02) and were satisfied with the treatment programme (84.8% vs 62.9%, p<0.001).
The selling of smartphones is increasing rapidly. About 75% of all cellphones sold in Sweden today are smartphones. Two million adults in Sweden have a smartphone. Many smartphone owners have at least one health app on their phone. Exercise, diet, and weight apps are the most popular types.
From our previous experience of an Internet-based programme, we have developed a treatment program designed for smartphone. The effect of the treatment programme will be evaluated after three months by comparing the effect in the "smartphone group" with the effect in the "waiting group".
Participants are consecutively recruited through our website. They answer an online screening survey with automated immediated response for initial screening of eligibility criteria. Informed consent and leakage diary (number of episodes of urinary leakage during 48 hours) are sent by post. After that, they answer a web questionnaire and finally they are interviewed by a researcher to confirm the diagnosis SUI and to ascertain that the patient is well informed of the study procedure.
Women are then randomized to either of the two groups. Women in the smartphone group get a smartphone application for iphone or android. Follow-up after three months with a web questionnaire and a leakage diary. After that the waiting group get their smartphone application.
We aim to recruit 120 women aged 18 and older via our website www.tät.nu. In the power calculation we assume that the improvement in the symptom score (ICIQ UI SF) and the QOL score (ICIQ luts QOL)in the smartphone group will be similar to the improvement we found in the postal group in our previous study. We also assume that the waiting group will improve in some extent.
To detect a difference between groups, power 80%, 2-side test and significance 0,05, group size as follow
ICIQ UI SF Smartphone group improves 2.9 (SD3,1) and waiting group 1,0 (SD2,0); 30 in each group
ICIQ luts QOL Smartphone group improves 4.6 (SD6,7) and waiting group 2.0(SD3.0), 35 in each group
PGI (patient´s global impression of improvement). 26,5% improves much or very much (smartphone) and 4% (waiting group):39 in each group
We expect a drop out rate of 33% and thus need approximately 120 persons, 60 in each group.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smartphone treatment | Active Comparator | Smartphone treatment with PFMT. |
|
| Waiting list | No Intervention | Waiting list for three months. They receive the smartphone application after follow-up. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartphone treatment with PFMT | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline, three months |
| International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) | 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. | baseline, three months |
| Measure | Description | Time Frame |
|---|---|---|
| Usage of Incontinence Aids | Usage of incontinence aids during the last 4 weeks. | three months |
| Patient Satisfaction | A self-rated question about if the current treatment was sufficient, with three response options |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eva Samuelsson, MD, PhD | Department of Public Health and Clinical Medicine, Umeå University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Umea University | Umeå | Umeå | S-90185 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30869644 | Derived | Asklund I, Samuelsson E, Hamberg K, Umefjord G, Sjostrom M. User Experience of an App-Based Treatment for Stress Urinary Incontinence: Qualitative Interview Study. J Med Internet Res. 2019 Mar 14;21(3):e11296. doi: 10.2196/11296. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Randomisation was performed by concealing the allocations in sequentially numbered, opaque, sealed envelopes. An independent administrator generated the allocation sequence and prepared 130 envelopes. The study coordinator opened one envelope for each participant and assigned an e-mail, with materials for the corresponding study group.
We recruited community-dwelling women, from March 2013 to October 2014, through our website. Interested women filled out a questionnaire to determine whether they met the study criteria. Eligible women received a letter with informed consent and a 2-day leakage diary, and after returning this they also answered a web-based questionnaire.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Smartphone Treatment | Smartphone treatment with PFMT. 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. Possibility to set reminders. The treatment period is three months |
| FG001 | Waiting List | Waiting list for three months. They receive the smartphone application after follow-up. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Smartphone Treatment | Smartphone treatment with pelvic floor muscle training (PFMT). 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. Possibility to set reminders. The treatment period is three months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | intention-to-treat analysis | Posted | Mean | Standard Deviation | units on a scale | baseline, three months |
|
3 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Smartphone Treatment | Smartphone treatment with PFMT. 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. Possibility to set reminders. The treatment period is three months |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eva Samuelsson | Umeå University, Umeå, Sweden | +46706966440 | eva.samuelsson@umu.se |
Not provided
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| three months |
| Incontinence Episode Frequency (IEF) | number of incontinence episodes per week | baseline, three months |
| Patient's Global Impression of Improvement Scale (PGI-I) | 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". | three months |
| BG001 |
| Waiting List |
Waiting list for three months. They receive the smartphone application after follow-up. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Smoking | Number | participants |
|
| Education | Number | participants |
|
| Parity | Number | participants |
|
| Regular Medication | Number | participants |
|
| Usage of incontinence aids | Usage of incontinence aids during the last 4 weeks. | Number | participants |
|
Waiting list for three months. They receive the smartphone application after follow-up. |
|
|
|
| Primary | International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) | 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. | intention-to-treat analysis | Posted | Mean | Standard Deviation | units on a scale | baseline, three months |
|
|
|
|
| Secondary | Usage of Incontinence Aids | Usage of incontinence aids during the last 4 weeks. | intention-to-treat analysis. Missing values at follow-up were replaced with the corresponding values at baseline (i.e., no change). | Posted | Number | participants | three months |
|
|
|
|
| Secondary | Patient Satisfaction | A self-rated question about if the current treatment was sufficient, with three response options | Data for this outcome measure could only be collected for the smartphone treatment group. | Posted | Number | participants | three months |
|
|
|
| Secondary | Incontinence Episode Frequency (IEF) | number of incontinence episodes per week | intention-to-treat analysis. Missing values at follow-up were replaced with the corresponding values at baseline (i.e., no change). | Posted | Median | Inter-Quartile Range | episodes per week | baseline, three months |
|
|
|
|
| Secondary | Patient's Global Impression of Improvement Scale (PGI-I) | 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". | intention-to-treat analysis. Missing values at follow-up were replaced with a neutral value (i.e., no change). | Posted | Number | participants | three months |
|
|
|
|
| 0 |
| 62 |
| 0 |
| 62 |
| EG001 | Waiting List | Waiting list for three months. They receive the smartphone application after follow-up. | 0 | 61 | 0 | 61 |
Not provided
Not provided
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 1-3 times/week |
|
| >3 times/week, but not daily |
|
| 1 aid a day |
|
| More than 1 aid a day |
|
| Title | Measurements |
|---|---|
|
| a little better |
|
| no change |
|
| a little worse |
|
| much worse |
|
| very much worse |
|