CompletedNot Applicable

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

Switzerland58 participantsStarted 2016-08

Plain-language summary

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.

Who can participate

Age range18 Years

SexFEMALE

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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

What they're measuring

Cure rates for stress urinary incontinence (SUI)

Timeframe: 6 months

Change from baseline in number of micturitions per day

Timeframe: Baseline, 6 months

Trial details

NCT IDNCT02815046

SponsorProf. Dr. Volker Viereck

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-12

View on ClinicalTrials.gov More Mixed Incontinence, Urge and Stress trials