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

Mixed Incontinence, Urge and Stress Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02815046
• Other study ID #: Botox-Bulkamid study
• Status: Completed
• Start date: August 2016
• Est. completion date: December 2019

Study information

• Verified date: March 2020
• Source: Cantonal Hospital, Frauenfeld
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Mixed Incontinence, Urge and Stress
• Urinary Incontinence
• Urinary Incontinence, Urge

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Cantonal Hospital Frauenfeld	Frauenfeld

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Volker Viereck

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure rates for stress urinary incontinence (SUI)	Number of participants with negative cough stress test and 90 % improved SUI-visual analog scale.	6 months
Primary	Change from baseline in number of micturitions per day		Baseline, 6 months
Secondary	Frequency of complications		intra-operative and post-operative follow-up up to 12 months
Secondary	Frequency of cough stress test levels	3 Levels: negative, only a few drops of urine, severe loss of urine	Baseline, 6 months, 12 months
Secondary	SUI-visual analog scale	Scale from 0-10: 0-no suffering - 10-severe suffering	Baseline, 6 months, 12 months
Secondary	UUI-visual analog scale	Scale from 0-10: 0-no suffering - 10-severe suffering	Baseline, 6 months, 12 months
Secondary	Change from baseline in number of micturitions per day		Baseline, 6 months, 12 months
Secondary	Change from baseline in number of urgency episodes per day		Baseline, 6 months, 12 months
Secondary	Change from baseline in number of urgency urinary incontinence episodes per 3 days		Baseline, 6 months, 12 months
Secondary	Change from baseline in urine volume per micturition		Baseline, 6 months, 12 months