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This study compares mixed urinary incontinence symptoms before and after a combined treatment with Botox and Bulkamid. Eligible for the study are adult females with a mixed urinary incontinence, having both urgency urinary symptoms and stress urinary symptoms.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Drug | Intravesical injections of Botulinum toxin A (Botox) into the bladder wall. |
| |
| Polyacrylamide hydrogel | Device | Midurethral injections of the bulking Agent Bulkamid into the submucosal tissues of the urethra. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cure rates for stress urinary incontinence (SUI) | Number of participants with negative cough stress test and 90 % improved SUI-visual analog scale. | 6 months |
| Change from baseline in number of micturitions per day | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of complications | intra-operative and post-operative follow-up up to 12 months | |
| Frequency of cough stress test levels | 3 Levels: negative, only a few drops of urine, severe loss of urine |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with mixed urinary incontinence (MUI) eligible for an intervention with Botox and Bulkamid.
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| Name | Affiliation | Role |
|---|---|---|
| Volker Viereck, MD | Cantonal Hospital, Frauenfeld | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cantonal Hospital Frauenfeld | Frauenfeld | Switzerland |
Publication in peer-reviewed journal
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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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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Baseline, 6 months, 12 months |
| SUI-visual analog scale | Scale from 0-10: 0-no suffering - 10-severe suffering | Baseline, 6 months, 12 months |
| UUI-visual analog scale | Scale from 0-10: 0-no suffering - 10-severe suffering | Baseline, 6 months, 12 months |
| Change from baseline in number of micturitions per day | Baseline, 6 months, 12 months |
| Change from baseline in number of urgency episodes per day | Baseline, 6 months, 12 months |
| Change from baseline in number of urgency urinary incontinence episodes per 3 days | Baseline, 6 months, 12 months |
| Change from baseline in urine volume per micturition | Baseline, 6 months, 12 months |
| 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 |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |