Mixed Urinary Incontinence Symptoms Before and After Treatment With Botox and Bulkamid
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ClinicalTrials.gov Identifier: NCT02815046
Recruitment Status :
First Posted : June 28, 2016
Last Update Posted : March 12, 2020
Prof. Dr. Volker Viereck
Information provided by (Responsible Party):
Prof. Dr. Volker Viereck, Cantonal Hospital, Frauenfeld
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.
Condition or disease
Mixed Incontinence, Urge and Stress
Drug: Botulinum toxin type ADevice: Polyacrylamide hydrogel
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)
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with mixed urinary incontinence (MUI) eligible for an intervention with Botox and Bulkamid.
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
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)