Web-based Management of Female Stress Urinary Incontinence

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.

Study Overview

• Status: Completed
• Conditions: Female Stress Urinary Incontinence
• Intervention / Treatment: Behavioral: Web-based treatment with PFMT and elements of CBT; Behavioral: Pamphlet treatment

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 Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Umeå, Sweden, S-90185
    • Umea University

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Umeå University
• Collaborators: 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

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: December 12, 2009
• First Submitted That Met QC Criteria: December 12, 2009
• First Posted (Estimate): December 15, 2009

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: treatment; cognitive behavioral therapy; eHealth; stress urinary incontinence; female; internet; life style; pelvic floor muscle training; pamphlet
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• 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)