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

NCT02815046 | Completed

• 1 other identifier: Botox-Bulkamid study
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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

Keywords

urgency urinary incontinence; stress urinary incontinence; Botulinum toxin A; Bulkamid

Outcome Measures

Primary Outcomes (2)

• Cure rates for stress urinary incontinence (SUI)

  Number of participants with negative cough stress test and 90 % improved SUI-visual analog scale.

  6 months

• Change from baseline in number of micturitions per day

  Baseline, 6 months

Secondary Outcomes (8)

• 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

• SUI-visual analog scale

  Baseline, 6 months, 12 months

• UUI-visual analog scale

  Baseline, 6 months, 12 months

• Change from baseline in number of micturitions per day

  Baseline, 6 months, 12 months

Interventions

Botulinum toxin type A DRUG

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

Also known as: Botox

Polyacrylamide hydrogel DEVICE

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

Also known as: Bulkamid

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with mixed urinary incontinence (MUI) eligible for an intervention with Botox and Bulkamid.

You may qualify if:

• 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

You may not qualify if:

• 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)
• Residual urine of \> 100 ml

Sponsors & Collaborators

• Prof. Dr. Volker Viereck: lead

Study Sites (1)

Cantonal Hospital Frauenfeld

Frauenfeld, Switzerland

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Volker Viereck, MD

  Cantonal Hospital, Frauenfeld

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: June 28, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 12, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)