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

Completed

• Conditions: Mixed Incontinence, Urge and Stress

• Registration Number: NCT02815046
• Lead Sponsor: Prof. Dr. Volker Viereck

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-08
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-28
• Study Start: 2016-08
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-11
• Last Update Posted: 2020-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 58

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cure rates for stress urinary incontinence (SUI)	6 months	Number of participants with negative cough stress test and 90 % improved SUI-visual analog scale.
Change from baseline in number of micturitions per day	Baseline, 6 months

Secondary Outcome Measures

Name	Time	Method
UUI-visual analog scale	Baseline, 6 months, 12 months	Scale from 0-10: 0-no suffering - 10-severe suffering
Frequency of complications	intra-operative and post-operative follow-up up to 12 months
Frequency of cough stress test levels	Baseline, 6 months, 12 months	3 Levels: negative, only a few drops of urine, severe loss of urine
SUI-visual analog scale	Baseline, 6 months, 12 months	Scale from 0-10: 0-no suffering - 10-severe suffering
Change from baseline in urine volume per micturition	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

Trial Locations

Locations (1)

Cantonal Hospital Frauenfeld; 🇨🇭 Frauenfeld, Switzerland