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Web-based Management of Female Stress Urinary Incontinence

Primary Purpose

Female Stress Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Web-based treatment with PFMT and elements of CBT
Pamphlet treatment
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Female Stress Urinary Incontinence focused on measuring female, stress urinary incontinence, treatment, pelvic floor muscle training, cognitive behavioral therapy, internet, life style, pamphlet, eHealth

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Umea University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Web-based treatment

Pamphlet treatment

Arm Description

Web-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist

Information (including life style), and PFMT exercises.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
December 12, 2009
Last Updated
February 16, 2022
Sponsor
Umeå University
Collaborators
Swedish Council for Working Life and Social Research, Jämtland County Council, Sweden, Västernorrland County Council, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT01032265
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University
Collaborators
Swedish Council for Working Life and Social Research, Jämtland County Council, Sweden, Västernorrland County Council, Sweden

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Stress Urinary Incontinence
Keywords
female, stress urinary incontinence, treatment, pelvic floor muscle training, cognitive behavioral therapy, internet, life style, pamphlet, eHealth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Web-based treatment
Arm Type
Active Comparator
Arm Description
Web-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
Arm Title
Pamphlet treatment
Arm Type
Active Comparator
Arm Description
Information (including life style), and PFMT exercises.
Intervention Type
Behavioral
Intervention Name(s)
Web-based treatment with PFMT and elements of CBT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pamphlet treatment
Intervention Description
125 women with SUI receive a pamphlet with information and a programme for PFMT.
Primary Outcome Measure Information:
Title
International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF)
Description
summed symptom-score, range 0-21, with higher scores indicating greater severity.
Time Frame
baseline, 4 months
Title
International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)
Description
condition-specific quality of life, summed score, range 19-76, higher scores indicate greater impact on quality of life.
Time Frame
baseline, 4 months
Secondary Outcome Measure Information:
Title
EuroQol Five Dimensions Visual Analogue Scale (EQ5D-VAS)
Description
health-specific quality of life, range 0-100, higher scores indicate better quality of life.
Time Frame
baseline, 4 months
Title
Usage of Incontinence Aids
Description
Only those using incontinence aids at baseline were included in the analysis.
Time Frame
baseline, 4 months
Title
Patient Satisfaction
Time Frame
4 months
Title
Incontinence Episode Frequency (IEF)
Description
number of incontinence episodes per week
Time Frame
baseline, 4 months
Title
Patient's Global Impression of Improvement Scale (PGI-I)
Time Frame
4 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Samuelsson, MD, PhD
Organizational Affiliation
Department of Public Health and Clinical Medicine, Umeå University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eva Samuelsson, MD, PhD
Organizational Affiliation
Department of Public Health and Clinical Medicine, Umeå University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Göran Umefjord, MD, PhD
Organizational Affiliation
Department of Public Health and Clinical Medicine, Umeå University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Umea University
City
Umeå
ZIP/Postal Code
S-90185
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
23350826
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.
Results Reference
derived
PubMed Identifier
22517196
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.
Results Reference
derived
Links:
URL
http://www.econtinence.se
Description
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.

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Web-based Management of Female Stress Urinary Incontinence

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