Web-based Management of Female Stress Urinary Incontinence

• ClinicalTrials.gov Identifier: NCT01032265
• Recruitment Status: Completed
• First Posted: December 15, 2009
• Results First Posted: March 13, 2013
• Last Update Posted: March 2, 2022
• Sponsor: Umeå University
• Collaborators: Swedish Council for Working Life and Social Research; Jämtland County Council, Sweden; Västernorrland County Council, Sweden
• Information provided by (Responsible Party): Eva Samuelsson, Umeå University

Study Description

Brief Summary:

The purpose of this study is to determine whether treatment of female stress urinary incontinence using a web-based programme is effective.

Condition or disease	Intervention/treatment	Phase
Female Stress Urinary Incontinence	Behavioral: Web-based treatment with PFMT and elements of CBT; Behavioral: Pamphlet treatment	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: December 2009
• Actual Primary Completion Date: April 2011
• Actual Study Completion Date: April 2011

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Web-based treatment; Web-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist	Behavioral: Web-based treatment with PFMT and elements of CBT; 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.
Active Comparator: Pamphlet treatment; Information (including life style), and PFMT exercises.	Behavioral: Pamphlet treatment; 125 women with SUI receive a pamphlet with information and a programme for PFMT.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. EuroQol Five Dimensions Visual Analogue Scale (EQ5D-VAS) [ Time Frame: baseline, 4 months ]
   health-specific quality of life, range 0-100, higher scores indicate better quality of life.
2. Usage of Incontinence Aids [ Time Frame: baseline, 4 months ]
   Only those using incontinence aids at baseline were included in the analysis.
3. Patient Satisfaction [ Time Frame: 4 months ]
4. Incontinence Episode Frequency (IEF) [ Time Frame: baseline, 4 months ]
   number of incontinence episodes per week
5. Patient's Global Impression of Improvement Scale (PGI-I) [ Time Frame: 4 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Sweden

Umea University

Umeå, Sweden, S-90185

Sponsors and Collaborators

Umeå University

Swedish Council for Working Life and Social Research

Jämtland County Council, Sweden

Västernorrland County Council, Sweden

Investigators

• Study Chair: Eva Samuelsson, MD, PhD; Department of Public Health and Clinical Medicine, Umeå University
• Principal Investigator: 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

More Information

Additional Information:

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. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sjöström 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.

Sjöström 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.

• Responsible Party: Eva Samuelsson, Associate professor, Umeå University
• ClinicalTrials.gov Identifier: NCT01032265
• Other Study ID Numbers: FAS dnr 2008-0952; 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 )
• First Posted: December 15, 2009
• Results First Posted: March 13, 2013
• Last Update Posted: March 2, 2022
• Last Verified: February 2022

Keywords provided by Eva Samuelsson, Umeå University:

female; stress urinary incontinence; treatment; pelvic floor muscle training; cognitive behavioral therapy; internet; life style; pamphlet; eHealth

Additional relevant MeSH terms:

Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Mental Disorders