Web-based Management of Female Stress Urinary Incontinence

NCT01032265 | Completed Results

• 7 other identifiers: FAS dnr 2008-0952VLL 759-2008VLL-68711SLS 2008-21468Visare Norr Project nr 40/2009JLL LS/1073/2008LVN 8160
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Female Stress Urinary Incontinence

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• EuroQol Five Dimensions Visual Analogue Scale (EQ5D-VAS)

  baseline, 4 months

• Usage of Incontinence Aids

  baseline, 4 months

• Patient Satisfaction

  4 months

• Incontinence Episode Frequency (IEF)

  baseline, 4 months

• Patient's Global Impression of Improvement Scale (PGI-I)

  4 months

Study Arms (2)

Web-based treatment

ACTIVE COMPARATOR

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

Pamphlet treatment

ACTIVE COMPARATOR

Information (including life style), and PFMT exercises.

Behavioral: Pamphlet treatment

Interventions

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.

Web-based treatment

Pamphlet treatment BEHAVIORAL

125 women with SUI receive a pamphlet with information and a programme for PFMT.

Pamphlet treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Umeå University: lead
• Swedish Council for Working Life and Social Research: collaborator
• Jämtland County Council, Sweden: collaborator
• Västernorrland County Council, Sweden: collaborator

Study Sites (1)

Umea University

Umeå, S-90185, Sweden

Location

Related Publications (3)

• 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.

  PMID: 39704322 DERIVED

• 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.

  PMID: 23350826 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.

  PMID: 22517196 DERIVED

Related 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.

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Eva Samuelsson
• Organization: Umeå University, Umeå, Sweden

eva.samuelsson@jll.se

+46706966440

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 12, 2009
• First Posted: December 15, 2009
• Study Start: December 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: March 2, 2022
• Results First Posted: March 13, 2013

Record last verified: 2022-02

Locations

SE (1)