Female Stress Urinary IncontinenceNCT01032265
Web-based Management of Female Stress Urinary Incontinence
A study testing Web-based treatment with PFMT and elements of CBT and Pamphlet treatment in people with Female Stress Urinary Incontinence, run by Umeå University at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether treatment of female stress urinary incontinence using a web-based programme is effective. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Female Stress Urinary Incontinence
- What is being tested?
- Web-based treatment with PFMT and elements of CBT and Pamphlet treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2009to Apr 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stress urinary incontinence
- leakage once a week or more often
- ability to read and write Swedish
- asset to computer with Internet connection
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Web-based Management of Female Stress Urinary Incontinence. Evaluation of a Treatment Programme With Pelvic Floor Muscle Training and Elements of Cognitive Behavioural Therapy
The purpose of this study is to determine whether treatment of female stress urinary incontinence using a web-based programme is effective.
Read the detailed description
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.
- Conditions
- Female Stress Urinary Incontinence
- Being tested
- Web-based treatment with PFMT and elements of CBT, Pamphlet treatment
- Keywords
- female, stress urinary incontinence, treatment, pelvic floor muscle training, cognitive behavioral therapy, internet, life style, pamphlet, eHealth
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based treatment with PFMT and elements of CBTBehavioural
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.
Pamphlet treatmentBehavioural
125 women with SUI receive a pamphlet with information and a programme for PFMT.
| Study group | Role | What they receive |
|---|---|---|
| Web-based treatment | Active comparator | Web-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist Receives: Behavioral: Web-based treatment with PFMT and elements of CBT |
| Pamphlet treatment | Active comparator | Information (including life style), and PFMT exercises. Receives: Behavioral: Pamphlet treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline, 4 months
Secondary outcomes (5)
EuroQol Five Dimensions Visual Analogue Scale (EQ5D-VAS)
health-specific quality of life, range 0-100, higher scores indicate better quality of life.
Measured: baseline, 4 months
Usage of Incontinence Aids
Only those using incontinence aids at baseline were included in the analysis.
Measured: baseline, 4 months
Patient Satisfaction
Measured: 4 months
Incontinence Episode Frequency (IEF)
number of incontinence episodes per week
Measured: baseline, 4 months
Patient's Global Impression of Improvement Scale (PGI-I)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Female Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Council for Working Life and Social Research, Jämtland County Council, Sweden, Västernorrland County Council, Sweden
- Responsible party
- Principal investigator, Eva Samuelsson, Umeå University
- Investigators
- Eva Samuelsson, MD, PhD, Study chair, Department of Public Health and Clinical Medicine, Umeå UniversityEva Samuelsson, MD, PhD, Principal investigator, Department of Public Health and Clinical Medicine, Umeå UniversityGöran Umefjord, MD, PhD, Principal investigator, Department of Public Health and Clinical Medicine, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032265
- Sponsor's protocol ID
- FAS dnr 2008-0952
- Other IDs
- VLL 759-2008, VLL-68711, SLS 2008-21468, Visare Norr Project nr 40/2009, JLL LS/1073/2008, LVN 8160
- Status last verified
- Feb 2022
- First submitted
- 12 Dec 2009
- Last updated
- 2 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 39704322Sjostrom 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.
PubMed 23350826Sjostrom 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.
PubMed 22517196
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Management of Female Stress Urinary Incontinence. Evaluation of a Treatment Programme With Pelvic Floor Muscle Training and Elements of Cognitive Behavioural Therapy
- ClinicalTrials.gov ID
- NCT01032265
- Acronym / sponsor ID
- FAS dnr 2008-0952
- Conditions
- Female Stress Urinary Incontinence
- Keywords
- female, stress urinary incontinence, treatment, pelvic floor muscle training, cognitive behavioral therapy, internet, life style, pamphlet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Swedish Council for Working Life and Social Research, Jämtland County Council, Sweden, Västernorrland County Council, Sweden
- Study start
- Dec 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 15 Dec 2009 (estimated)
- Results
- Posted 13 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether treatment of female stress urinary incontinence using a web-based programme is effective.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based treatment | Active comparator | Behavioral: Web-based treatment with PFMT and elements of CBTWeb-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist |
| Pamphlet treatment | Active comparator | Behavioral: Pamphlet treatmentInformation (including life style), and PFMT exercises. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- stress urinary incontinence
- leakage once a week or more often
- ability to read and write Swedish
- asset to computer with Internet connection
Key exclusion criteria (8 listed)
- pregnancy
- former incontinence surgery
- known malignancy in lower abdomen
- difficulties with passing urine
- visual blood in urine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based treatment with PFMT and elements of CBT125 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. | Behavioural | Web-based treatment |
| Pamphlet treatment125 women with SUI receive a pamphlet with information and a programme for PFMT. | Behavioural | Pamphlet treatment |
Primary outcome
International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF)
Time frame: baseline, 4 months
summed symptom-score, range 0-21, with higher scores indicating greater severity.
International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)
Time frame: baseline, 4 months
condition-specific quality of life, summed score, range 19-76, higher scores indicate greater impact on quality of life.
5 secondary outcomes
EuroQol Five Dimensions Visual Analogue Scale (EQ5D-VAS)
Time frame: baseline, 4 months
Usage of Incontinence Aids
Time frame: baseline, 4 months
Patient Satisfaction
Time frame: 4 months
Incontinence Episode Frequency (IEF)
Time frame: baseline, 4 months
Patient's Global Impression of Improvement Scale (PGI-I)
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39704322Hay-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.
- Derived from this study: PubMed 23350826Sjostrom 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.
- Derived from this study: PubMed 22517196Sjostrom 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.
- 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.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Samuelsson, MD, PhD study chair
Department of Public Health and Clinical Medicine, Umeå University
Eva Samuelsson, MD, PhD principal investigator
Department of Public Health and Clinical Medicine, Umeå University
Göran Umefjord, MD, PhD principal investigator
Department of Public Health and Clinical Medicine, Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based treatment with PFMT and elements of CBT and Pamphlet treatment in people with Female Stress Urinary Incontinence, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) (time frame: baseline, 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01032265, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.