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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bulkamid | Other | Injection with Bulkamid |
|
| expectance | Other | The expectance arm will after 2 month have the same treatment as the treatment arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bulkamid | Device | injection of Bulkamid in the urethra |
| |
| Bulkamid expectation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | less intcontines | 2 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | less inkontinens | 12 month |
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Inclusion Criteria:
Ability to understand the information and to give informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| P-G Larsson, professor | Departm Ob/Gyn Kärnsjukhuset, 541 85 SKövde, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deprtm Ob/Gyn | Skövde | SE54185 | Sweden |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Group 1 will get treatment and Group 2 will have no treatment for 2 month
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| Device |
expectance |
|
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |