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

Prof. Dr. Volker Viereck

Status: Completed

Conditions: Mixed Incontinence, Urge and Stress

Treatments: Drug: Botulinum toxin type A; Device: Polyacrylamide hydrogel

Study type: Observational

Funder types: Other

Identifiers

NCT02815046

Botox-Bulkamid study

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women aged ≥ 18 years.
2. 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.
3. All criteria for the indication to treat patient with Botox are met.
4. All criteria for the indication to treat patient with Bulkamid are met.
5. Participant has given informed consent

Exclusion criteria

1. All contraindications for Bulkamid or Botox
2. Previous treatment with Botulinum toxin (within last 3 months)
3. Previous treatment with Bulkamid or other bulking agent (within last 3 months)
4. Participant is pregnant or lactating
5. Current urinary tract infection (in which case this has to be treated first before patient might be included)
6. Residual urine of > 100 ml