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| ID | Type | Description | Link |
|---|---|---|---|
| VLL 759-2008 | Other Identifier | Umeå University and County Councils of Northern Sweden | |
| VLL-68711 | Other Identifier | Umeå University and County Councils of Northern Sweden | |
| SLS 2008-21468 | Other Identifier | Swedish Society of Medicine | |
| Visare Norr Project nr 40/2009 | Other Identifier | County Councils of Northern Sweden | |
| JLL LS/1073/2008 | Other Identifier | County Council of Jämtland | |
| LVN 8160 | Other Identifier | County Council of Västernorrland |
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| Name | Class |
|---|---|
| Swedish Council for Working Life and Social Research | OTHER |
| Jämtland County Council, Sweden | OTHER_GOV |
| Västernorrland County Council, Sweden | OTHER_GOV |
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The purpose of this study is to determine whether treatment of female stress urinary incontinence using a web-based programme is effective.
Female urinary incontinence 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 stress urinary incontinence (SUI), i.e leakage when coughing, sneezing or jumping. There is no association between SUI and serious medical conditions. Thus investigation can be kept to a minimum, including structured history taking and a bladder diary for correct diagnosis. Treatment with lifestyle intervention and pelvic floor muscle training (PFMT) give improvement or cure in 60-70% of women. A small study indicates that treatment with cognitive behavioural therapy (CBT) may improve incontinence-related quality of life and symptoms of urinary incontinence. Web-based management of SUI has as far as we know never been evaluated in a randomized controlled study. The aim of this study is to determine if web-based management of female SUI, with a treatment using PFMT and elements of CBT is effective compared to treatment supported by a pamphlet. The duration of the treatment programme is three months, follow-up at four months, 1 year and two years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Web-based treatment | Active Comparator | Web-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist |
|
| Pamphlet treatment | Active Comparator | Information (including life style), and PFMT exercises. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Web-based treatment with PFMT and elements of CBT | Behavioral | 125 women with stress urinary incontinence(SUI) participate in web-based treatment for 3 months. Treatment consists of information, PFMT and uses elements of CBT. It includes regular email contact with urotherapist. |
| Measure | Description | Time Frame |
|---|---|---|
| International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) | summed symptom-score, range 0-21, with higher scores indicating greater severity. | baseline, 4 months |
| International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) | condition-specific quality of life, summed score, range 19-76, higher scores indicate greater impact on quality of life. | baseline, 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| EuroQol Five Dimensions Visual Analogue Scale (EQ5D-VAS) | health-specific quality of life, range 0-100, higher scores indicate better quality of life. | baseline, 4 months |
| Usage of Incontinence Aids |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva Samuelsson, MD, PhD | Department of Public Health and Clinical Medicine, Umeå University | Study Chair |
| Eva Samuelsson, MD, PhD | Department of Public Health and Clinical Medicine, Umeå University | Principal Investigator |
| Göran Umefjord, MD, PhD | Department of Public Health and Clinical Medicine, Umeå University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Umea University | Umeå | S-90185 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39704322 | Derived | Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2. | |
| 23350826 |
| Label | URL |
|---|---|
| Click here for more information on this study. Web-based management of female stress urinary incontinence. Evaluation of a treatment programme using pelvic floor muscle training and elements of cognitive behavioural therapy. | View source |
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Randomisation was through a pre-specified computer-generated list, in blocks of eight. An independent administrator kept the list and consecutively allocated eligible participants to one of the two intervention groups. There was no blinding of group allocation to study participants, health care providers, or researchers.
Online recruitment via the project´s open access website, Dec 2009 - Oct 2010. Interested women answered an online survey for screening of the eligibility criteria. If eligible they were sent a postal questionnaire, including a 2-day bladder diary. Finally, to confirm the clinical diagnosis all women were interviewed by telephone by a urotherapist.
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| ID | Title | Description |
|---|---|---|
| FG000 | Postal Treatment | Information (including life style), and PFMT exercises. |
| FG001 | Internet-based Treatment | Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Postal Treatment | Information (including life style), and PFMT exercises. |
| BG001 | Internet-based Treatment | Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist |
| 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) | summed symptom-score, range 0-21, with higher scores indicating greater severity. | Intention-to-treat | Posted | Mean | Standard Deviation | units on a scale | baseline, 4 months |
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Postal Treatment | Information (including life style), and PFMT exercises. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lower abdominal pain when performing pelvic floor muscle training | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eva Samuelsson | Umeå University, Umeå, Sweden | +46706966440 | eva.samuelsson@jll.se |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| Pamphlet treatment | Behavioral | 125 women with SUI receive a pamphlet with information and a programme for PFMT. |
|
Only those using incontinence aids at baseline were included in the analysis.
| baseline, 4 months |
| Patient Satisfaction | 4 months |
| Incontinence Episode Frequency (IEF) | number of incontinence episodes per week | baseline, 4 months |
| Patient's Global Impression of Improvement Scale (PGI-I) | 4 months |
| Sjostrom M, Umefjord G, Stenlund H, Carlbring P, Andersson G, Samuelsson E. Internet-based treatment of stress urinary incontinence: a randomised controlled study with focus on pelvic floor muscle training. BJU Int. 2013 Aug;112(3):362-72. doi: 10.1111/j.1464-410X.2012.11713.x. Epub 2013 Jan 25. |
| 22517196 | Derived | Sjostrom M, Stenlund H, Johansson S, Umefjord G, Samuelsson E. Stress urinary incontinence and quality of life: a reliability study of a condition-specific instrument in paper and web-based versions. Neurourol Urodyn. 2012 Nov;31(8):1242-6. doi: 10.1002/nau.22240. Epub 2012 Apr 19. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass index | Mean | Standard Deviation | kg/m2 |
|
| Smoking | Number | Participants |
|
| Education | Number | Participants |
|
| Number of births (Parity) | number of births | Number | Participants |
|
| Menopausal status | Number | Participants |
|
| Baseline characteristics for postal treatment group, internet-based treatment group and total | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) | condition-specific quality of life, summed score, range 19-76, higher scores indicate greater impact on quality of life. | Intention-to-treat | Posted | Mean | Standard Deviation | units on a scale | baseline, 4 months |
|
|
|
|
| Secondary | EuroQol Five Dimensions Visual Analogue Scale (EQ5D-VAS) | health-specific quality of life, range 0-100, higher scores indicate better quality of life. | Intention-to-treat | Posted | Mean | Standard Deviation | units on a scale | baseline, 4 months |
|
|
|
|
| Secondary | Usage of Incontinence Aids | Only those using incontinence aids at baseline were included in the analysis. | Intention-to-treat | Posted | Number | participants | baseline, 4 months |
|
|
|
|
| Secondary | Patient Satisfaction | Intention-to-treat | Posted | Number | participants | 4 months |
|
|
|
|
| Secondary | Incontinence Episode Frequency (IEF) | number of incontinence episodes per week | Intention-to-treat | Posted | Mean | Standard Deviation | episodes per week | baseline, 4 months |
|
|
|
|
| Secondary | Patient's Global Impression of Improvement Scale (PGI-I) | Intention-to-treat | Posted | Number | participants | 4 months |
|
|
|
|
| 0 |
| 126 |
| 0 |
| 126 |
| EG001 | Internet-based Treatment | Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist | 0 | 124 | 1 | 124 |
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| 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 |
| Same as before |
|
| More than before |
|
| neither good or bad |
|
| bad |
|
| very bad |
|
| Missing |
|
| a little better |
|
| no change |
|
| a little worse |
|
| much worse |
|
| very much worse |
|
| Missing |
|