Female Stress Urinary Incontinence
Conditions
Keywords
female, stress urinary incontinence, treatment, pelvic floor muscle training, cognitive behavioral therapy, internet, life style, pamphlet, eHealth
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.
Interventions
BEHAVIORALWeb-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.
BEHAVIORALPamphlet treatment
125 women with SUI receive a pamphlet with information and a programme for PFMT.
Sponsors
Swedish Council for Working Life and Social Research
Jämtland County Council, Sweden
Västernorrland County Council, Sweden
Umeå University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) | baseline, 4 months | 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) | baseline, 4 months | condition-specific quality of life, summed score, range 19-76, higher scores indicate greater impact on quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 4 months | — |
| EuroQol Five Dimensions Visual Analogue Scale (EQ5D-VAS) | baseline, 4 months | health-specific quality of life, range 0-100, higher scores indicate better quality of life. |
| Patient's Global Impression of Improvement Scale (PGI-I) | 4 months | — |
| Incontinence Episode Frequency (IEF) | baseline, 4 months | number of incontinence episodes per week |
| Usage of Incontinence Aids | baseline, 4 months | Only those using incontinence aids at baseline were included in the analysis. |
Countries
Sweden
Participant flow
Recruitment details
Online recruitment via the project´s open access website, Dec 2009 - Oct 2010. Interested women answered an online survey for screening of the eligibility criteria. If eligible they were sent a postal questionnaire, including a 2-day bladder diary. Finally, to confirm the clinical diagnosis all women were interviewed by telephone by a urotherapist.
Pre-assignment details
Randomisation was through a pre-specified computer-generated list, in blocks of eight. An independent administrator kept the list and consecutively allocated eligible participants to one of the two intervention groups. There was no blinding of group allocation to study participants, health care providers, or researchers.
Participants by arm
| Arm | Count |
|---|---|
| Postal Treatment Information (including life style), and PFMT exercises. | 126 |
| Internet-based Treatment Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist | 124 |
| Total | 250 |
Baseline characteristics
| Characteristic | Total | Postal Treatment | Internet-based Treatment |
|---|---|---|---|
| Age, Continuous | 48.6 years STANDARD_DEVIATION 10.2 | 49.4 years STANDARD_DEVIATION 9.8 | 47.9 years STANDARD_DEVIATION 10.6 |
| Baseline characteristics for postal treatment group, internet-based treatment group and total | 250 participants | 126 participants | 124 participants |
| Body Mass index | 24.6 kg/m2 STANDARD_DEVIATION 3.9 | 24.5 kg/m2 STANDARD_DEVIATION 3.6 | 24.7 kg/m2 STANDARD_DEVIATION 4.2 |
| Education < 3 years at university level | 53 Participants | 28 Participants | 25 Participants |
| Education >=3 years at university level | 135 Participants | 72 Participants | 63 Participants |
| Education Lower | 62 Participants | 26 Participants | 36 Participants |
| Menopausal status Not postmenopausal | 150 Participants | 73 Participants | 77 Participants |
| Menopausal status Postmenopausal | 91 Participants | 48 Participants | 43 Participants |
| Menopausal status Unknown | 9 Participants | 5 Participants | 4 Participants |
| Number of births (Parity) 1 child | 35 Participants | 15 Participants | 20 Participants |
| Number of births (Parity) 2 children | 123 Participants | 62 Participants | 61 Participants |
| Number of births (Parity) 3 children | 52 Participants | 31 Participants | 21 Participants |
| Number of births (Parity) 4 children | 22 Participants | 11 Participants | 11 Participants |
| Number of births (Parity) No childbirth | 18 Participants | 7 Participants | 11 Participants |
| Region of Enrollment Sweden | 250 participants | 126 participants | 124 participants |
| Sex: Female, Male Female | 250 Participants | 126 Participants | 124 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Smoking Non-smoker | 241 Participants | 121 Participants | 120 Participants |
| Smoking Smoker | 9 Participants | 5 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 126 | 1 / 124 |
| serious Total, serious adverse events | 0 / 126 | 0 / 124 |
Outcome results
Primary
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.
Time frame: baseline, 4 months
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Postal Treatment | International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) | Baseline | 33.6 units on a scale | Standard Deviation 8.2 |
| Postal Treatment | International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) | 4 month follow-up | 28.8 units on a scale | Standard Deviation 7.3 |
| Internet-based Treatment | International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) | Baseline | 33.6 units on a scale | Standard Deviation 6.8 |
| Internet-based Treatment | International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) | 4 month follow-up | 27.8 units on a scale | Standard Deviation 6 |
Comparison: analysis between groupsp-value: 0.52Mixed Models Analysis
Primary
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.
Time frame: baseline, 4 months
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Postal Treatment | International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) | Baseline | 10.3 units on a scale | Standard Deviation 3.5 |
| Postal Treatment | International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) | 4 month follow-up | 7.3 units on a scale | Standard Deviation 3.9 |
| Internet-based Treatment | International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) | Baseline | 10.4 units on a scale | Standard Deviation 3.1 |
| Internet-based Treatment | International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) | 4 month follow-up | 6.9 units on a scale | Standard Deviation 3.1 |
Comparison: analysis between groupsp-value: 0.27Mixed Models Analysis
Secondary
EuroQol Five Dimensions Visual Analogue Scale (EQ5D-VAS)
health-specific quality of life, range 0-100, higher scores indicate better quality of life.
Time frame: baseline, 4 months
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Postal Treatment | EuroQol Five Dimensions Visual Analogue Scale (EQ5D-VAS) | Baseline | 79.2 units on a scale | Standard Deviation 14 |
| Postal Treatment | EuroQol Five Dimensions Visual Analogue Scale (EQ5D-VAS) | 4 month follow-up | 81.8 units on a scale | Standard Deviation 13.9 |
| Internet-based Treatment | EuroQol Five Dimensions Visual Analogue Scale (EQ5D-VAS) | Baseline | 79.1 units on a scale | Standard Deviation 13.6 |
| Internet-based Treatment | EuroQol Five Dimensions Visual Analogue Scale (EQ5D-VAS) | 4 month follow-up | 83.3 units on a scale | Standard Deviation 10.3 |
Comparison: analysis between groupsp-value: 0.3Mixed Models Analysis
Secondary
Incontinence Episode Frequency (IEF)
number of incontinence episodes per week
Time frame: baseline, 4 months
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Postal Treatment | Incontinence Episode Frequency (IEF) | Baseline | 9.4 episodes per week | Standard Deviation 8.6 |
| Postal Treatment | Incontinence Episode Frequency (IEF) | 4 month follow-up | 4.4 episodes per week | Standard Deviation 6.7 |
| Internet-based Treatment | Incontinence Episode Frequency (IEF) | Baseline | 12.7 episodes per week | Standard Deviation 12 |
| Internet-based Treatment | Incontinence Episode Frequency (IEF) | 4 month follow-up | 4.8 episodes per week | Standard Deviation 7.7 |
Comparison: analysis between groupsp-value: 0.23negative binomial regression
Secondary
Patient Satisfaction
Time frame: 4 months
Population: Intention-to-treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Postal Treatment | Patient Satisfaction | very good | 15 participants |
| Postal Treatment | Patient Satisfaction | good | 56 participants |
| Postal Treatment | Patient Satisfaction | neither good or bad | 31 participants |
| Postal Treatment | Patient Satisfaction | bad | 8 participants |
| Postal Treatment | Patient Satisfaction | very bad | 3 participants |
| Postal Treatment | Patient Satisfaction | Missing | 0 participants |
| Internet-based Treatment | Patient Satisfaction | very bad | 0 participants |
| Internet-based Treatment | Patient Satisfaction | very good | 46 participants |
| Internet-based Treatment | Patient Satisfaction | bad | 3 participants |
| Internet-based Treatment | Patient Satisfaction | good | 43 participants |
| Internet-based Treatment | Patient Satisfaction | Missing | 2 participants |
| Internet-based Treatment | Patient Satisfaction | neither good or bad | 13 participants |
Comparison: analysis between groupsp-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Patient's Global Impression of Improvement Scale (PGI-I)
Time frame: 4 months
Population: Intention-to-treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Postal Treatment | Patient's Global Impression of Improvement Scale (PGI-I) | very much better | 4 participants |
| Postal Treatment | Patient's Global Impression of Improvement Scale (PGI-I) | much better | 26 participants |
| Postal Treatment | Patient's Global Impression of Improvement Scale (PGI-I) | a little better | 60 participants |
| Postal Treatment | Patient's Global Impression of Improvement Scale (PGI-I) | no change | 19 participants |
| Postal Treatment | Patient's Global Impression of Improvement Scale (PGI-I) | a little worse | 3 participants |
| Postal Treatment | Patient's Global Impression of Improvement Scale (PGI-I) | much worse | 1 participants |
| Postal Treatment | Patient's Global Impression of Improvement Scale (PGI-I) | very much worse | 0 participants |
| Postal Treatment | Patient's Global Impression of Improvement Scale (PGI-I) | Missing | 0 participants |
| Internet-based Treatment | Patient's Global Impression of Improvement Scale (PGI-I) | Missing | 2 participants |
| Internet-based Treatment | Patient's Global Impression of Improvement Scale (PGI-I) | very much better | 12 participants |
| Internet-based Treatment | Patient's Global Impression of Improvement Scale (PGI-I) | a little worse | 1 participants |
| Internet-based Treatment | Patient's Global Impression of Improvement Scale (PGI-I) | much better | 31 participants |
| Internet-based Treatment | Patient's Global Impression of Improvement Scale (PGI-I) | very much worse | 0 participants |
| Internet-based Treatment | Patient's Global Impression of Improvement Scale (PGI-I) | a little better | 48 participants |
| Internet-based Treatment | Patient's Global Impression of Improvement Scale (PGI-I) | much worse | 0 participants |
| Internet-based Treatment | Patient's Global Impression of Improvement Scale (PGI-I) | no change | 13 participants |
Comparison: analysis between groupsp-value: 0.01Wilcoxon (Mann-Whitney)
Secondary
Usage of Incontinence Aids
Only those using incontinence aids at baseline were included in the analysis.
Time frame: baseline, 4 months
Population: Intention-to-treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Postal Treatment | Usage of Incontinence Aids | No use | 11 participants |
| Postal Treatment | Usage of Incontinence Aids | Less than before | 23 participants |
| Postal Treatment | Usage of Incontinence Aids | Same as before | 46 participants |
| Postal Treatment | Usage of Incontinence Aids | More than before | 2 participants |
| Internet-based Treatment | Usage of Incontinence Aids | More than before | 0 participants |
| Internet-based Treatment | Usage of Incontinence Aids | No use | 17 participants |
| Internet-based Treatment | Usage of Incontinence Aids | Same as before | 32 participants |
| Internet-based Treatment | Usage of Incontinence Aids | Less than before | 30 participants |
Comparison: analysis between groupsp-value: 0.02Wilcoxon (Mann-Whitney)