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

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ClinicalTrials.gov Identifier: NCT02815046
Recruitment Status : Completed
First Posted : June 28, 2016
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Volker Viereck, Cantonal Hospital, Frauenfeld

Study Description
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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.

Condition or disease Intervention/treatment
Mixed Incontinence, Urge and Stress Drug: Botulinum toxin type A Device: Polyacrylamide hydrogel

Study Design
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Study Type : Observational
Actual Enrollment : 58 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Study Start Date : August 2016
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

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Groups and Cohorts
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Intervention Details:
  • Drug: Botulinum toxin type A
    Intravesical injections of Botulinum toxin A (Botox) into the bladder wall.
    Other Name: Botox
  • Device: Polyacrylamide hydrogel
    Midurethral injections of the bulking Agent Bulkamid into the submucosal tissues of the urethra.
    Other Name: Bulkamid

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with mixed urinary incontinence (MUI) eligible for an intervention with Botox and Bulkamid.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02815046


Locations
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Switzerland
Cantonal Hospital Frauenfeld
Frauenfeld, Switzerland
Sponsors and Collaborators
Prof. Dr. Volker Viereck
Investigators
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Principal Investigator: Volker Viereck, MD Cantonal Hospital, Frauenfeld
More Information
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Responsible Party: Prof. Dr. Volker Viereck, Professor, MD, Cantonal Hospital, Frauenfeld
ClinicalTrials.gov Identifier: NCT02815046    
Other Study ID Numbers: Botox-Bulkamid study
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication in peer-reviewed journal
Keywords provided by Prof. Dr. Volker Viereck, Cantonal Hospital, Frauenfeld:
urgency urinary incontinence
stress urinary incontinence
Botulinum toxin A
Bulkamid
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Botulinum Toxins
 Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents