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

- 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
- 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 ]
- 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 ]

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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 |
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

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
Switzerland | |
Cantonal Hospital Frauenfeld | |
Frauenfeld, Switzerland |
Principal Investigator: | Volker Viereck, MD | Cantonal Hospital, Frauenfeld |
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 |
urgency urinary incontinence stress urinary incontinence Botulinum toxin A Bulkamid |
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 |