Mixed Urinary Incontinence Symptoms Before and After Treatment With Botox and Bulkamid

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Non-randomized, Single-center Observational Study of Outcome Measures of Patients Suffering From Mixed Urinary Incontinence Before and After Surgical Procedure With Botulinum Toxin and Polyacrylamide Hydrogel (PAHG)

Conditions
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Mixed Incontinence, Urge and Stress

Intervention / Treatment
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* Drug: Botulinum toxin type A
* Device: Polyacrylamide hydrogel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged ≥ 18 years. Clinically diagnosed therapy-refractory mixed urinary incontinence (MUI) based on cough test, urodynamic evaluation, 3-day micturition diary, incontinence-questionnaire with visual analog scales for SUI and UUI. All criteria for the indication to treat patient with Botox are met. All criteria for the indication to treat patient with Bulkamid are met. Participant has given informed consent Exclusion Criteria: All contraindications for Bulkamid or Botox Previous treatment with Botulinum toxin (within last 3 months) Previous treatment with Bulkamid or other bulking agent (within last 3 months) Participant is pregnant or lactating Current urinary tract infection (in which case this has to be treated first before patient might be included) Residual urine of > 100 ml

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Botulinum toxin type A|Intravesical injections of Botulinum toxin A (Botox) into the bladder wall.|
|Device: Polyacrylamide hydrogel|Midurethral injections of the bulking Agent Bulkamid into the submucosal tissues of the urethra.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urgency urinary incontinence, stress urinary incontinence, Botulinum toxin A, Bulkamid