Treatment, Urinary Stress Incontinence
Conditions
Brief summary
The aim of this prospective, randomized study of Bulkamid treatment is to investigate the efficacy of Bulkamid treatment in women with urinary stress incontinence not suitable to TVT-procedure because of suspected ISD.
Detailed description
The aim of this prospective, randomized study is to investigate the effect of Bulkamid injection for women with urinary stress incontinence and not suitable to TVT-procedure because of suspected ISD and compare this treatment with no or traditional treatment. The primary endpoint for efficacy will be reduction of leakage during pad-test at 2 months compared with pad- test before injection. Secondary endpoints will be patient satisfaction measured at both 2 and 12 months using a questionnaire and the number of side effects.
Interventions
DEVICEBulkamid
injection of Bulkamid in the urethra
DEVICEBulkamid expectation
expectance
Sponsors
Skaraborg Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Group 1 will get treatment and Group 2 will have no treatment for 2 month
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Ability to understand the information and to give informed consent. * At least 50 years of age * History of urinary leakage during low grade physical activity. A woman with genuine stress incontinence has urinary incontinence during running or jumping. Women with suspected ISD have incontinence at much lower grade of physical activity such as slow walking or standing up and just coughing. Walking, standing up from a chair, and coughing are regarded as low grade of physical activity. * A positive pad-test (after coughing 10 times) with increase of minimum of 10 grams of urine with 300 ml in the bladder or a 24 h pad-test of more than 100 mg of urine * No hypermobility of the urethra during cough test. * Low pressure of the urethra (optional?) * With a of average miction volume of minimum 150 ml and at least one volume of more than 250
Exclusion criteria
* Women with hypermobility of the urethra during coughing and positive Bonney's test * Women suitable for a TVT procedure. * Positive urinary culture * Urge incontinence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| After 2 months a scheduled visit with a new pad-test will be performed and the questionnaires UDI-6 (lover urinary tract symptoms) and IIQ-7 (quality of life) will be filled in. | 2 month | less intcontines |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| After 12 months a scheduled visit with new pad-test will be performed and the questionnaires UDI-6 (lover urinary tract symptoms) and IIQ-7 (quality of life) will be filled in. | 12 month | less inkontinens |
Countries
Sweden
Outcome results
None listed