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

NCT ID: NCT02815046

Last Updated: 2020-03-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 58 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2019-12-31

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.

Conditions

Mixed Incontinence, Urge and Stress

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Botulinum toxin type A

Intravesical injections of Botulinum toxin A (Botox) into the bladder wall.

Intervention Type: DRUG

Polyacrylamide hydrogel

Midurethral injections of the bulking Agent Bulkamid into the submucosal tissues of the urethra.

Intervention Type: DEVICE

Other Intervention Names

Botox; Bulkamid

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Prof. Dr. Volker Viereck

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Volker Viereck

Professor, MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Volker Viereck, MD

Role: PRINCIPAL_INVESTIGATOR

Cantonal Hospital, Frauenfeld

Locations

Cantonal Hospital Frauenfeld

Frauenfeld, , Switzerland

Countries

Switzerland

Other Identifiers

Botox-Bulkamid study

Identifier Type: -

Identifier Source: org_study_id