Clinical trial NCT01032265: Web-based Management of Female Stress Urinary Incontinence
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Stress Urinary Incontinence
Keywords: female
stress urinary incontinence
treatment
pelvic floor muscle training
cognitive behavioral therapy
internet
life style
pamphlet
eHealth
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Swedish Council for Working Life and Social Research
name: Jämtland County Council, Sweden
name: Västernorrland County Council, Sweden
First posted: 2009-12-15
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* stress urinary incontinence
* leakage once a week or more often
* ability to read and write Swedish
* asset to computer with Internet connection

Exclusion Criteria:

* 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

Primary outcomes:
measure: International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF)
timeFrame: baseline, 4 months
measure: International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)
timeFrame: baseline, 4 months
Secondary outcomes:
measure: EuroQol Five Dimensions Visual Analogue Scale (EQ5D-VAS)
timeFrame: baseline, 4 months
measure: Usage of Incontinence Aids
timeFrame: baseline, 4 months
measure: Patient Satisfaction
timeFrame: 4 months
measure: Incontinence Episode Frequency (IEF)
timeFrame: baseline, 4 months
measure: Patient's Global Impression of Improvement Scale (PGI-I)
timeFrame: 4 months
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umea University
Study officials:
affiliation: Department of Public Health and Clinical Medicine, Umeå University
name: Eva Samuelsson, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Public Health and Clinical Medicine, Umeå University
name: Eva Samuelsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Public Health and Clinical Medicine, Umeå University
name: Göran Umefjord, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.