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

Overview

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.

Full Title of Study: “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)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2019

Interventions

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Cure rates for stress urinary incontinence (SUI)
    • Time Frame: 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
    • Time Frame: Baseline, 6 months

Secondary Measures

  • Frequency of complications
    • Time Frame: intra-operative and post-operative follow-up up to 12 months
  • Frequency of cough stress test levels
    • Time Frame: Baseline, 6 months, 12 months
    • 3 Levels: negative, only a few drops of urine, severe loss of urine
  • SUI-visual analog scale
    • Time Frame: Baseline, 6 months, 12 months
    • Scale from 0-10: 0-no suffering – 10-severe suffering
  • UUI-visual analog scale
    • Time Frame: Baseline, 6 months, 12 months
    • Scale from 0-10: 0-no suffering – 10-severe suffering
  • Change from baseline in number of micturitions per day
    • Time Frame: Baseline, 6 months, 12 months
  • Change from baseline in number of urgency episodes per day
    • Time Frame: Baseline, 6 months, 12 months
  • Change from baseline in number of urgency urinary incontinence episodes per 3 days
    • Time Frame: Baseline, 6 months, 12 months
  • Change from baseline in urine volume per micturition
    • Time Frame: Baseline, 6 months, 12 months

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Prof. Dr. Volker Viereck
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Prof. Dr. Volker Viereck, Professor, MD – Cantonal Hospital, Frauenfeld
  • Overall Official(s)
    • Volker Viereck, MD, Principal Investigator, Cantonal Hospital, Frauenfeld

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