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Completed

NCT Number: NCT02815046

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Cantonal Hospital Frauenfeld

Frauenfeld, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Botulinum Toxin Type A

Drug

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

Other names: Botox

Polyacrylamide hydrogel

Device

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

Other names: Bulkamid

Primary outcomes

  1. 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.

  2. Change from baseline in number of micturitions per day

    Time frame: Baseline, 6 months

Secondary outcomes

  1. Frequency of complications

    Time frame: intra-operative and post-operative follow-up up to 12 months

  2. 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

  3. SUI-visual analog scale

    Time frame: Baseline, 6 months, 12 months

    Scale from 0-10: 0-no suffering - 10-severe suffering

  4. UUI-visual analog scale

    Time frame: Baseline, 6 months, 12 months

    Scale from 0-10: 0-no suffering - 10-severe suffering

  5. Change from baseline in number of micturitions per day

    Time frame: Baseline, 6 months, 12 months

  6. Change from baseline in number of urgency episodes per day

    Time frame: Baseline, 6 months, 12 months

  7. Change from baseline in number of urgency urinary incontinence episodes per 3 days

    Time frame: Baseline, 6 months, 12 months

  8. Change from baseline in urine volume per micturition

    Time frame: Baseline, 6 months, 12 months

Sponsors and collaborators

Lead sponsor

Prof. Dr. Volker Viereck

Other

Registry information

Official study 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)

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 28, 2016
Registry last updated
Mar 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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