Mixed Incontinence, Urge and StressNCT02815046
Mixed Urinary Incontinence Symptoms Before and After Treatment With Botox and Bulkamid
An observational study of Mixed Incontinence, Urge and Stress, run by Prof. Dr. Volker Viereck at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mixed Incontinence, Urge and Stress
- What is being tested?
- Botulinum toxin type A and Polyacrylamide hydrogel
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 58 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2016to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with mixed urinary incontinence (MUI) eligible for an intervention with Botox and Bulkamid.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
- Being tested
- Botulinum toxin type A, Polyacrylamide hydrogel
- Keywords
- urgency urinary incontinence, stress urinary incontinence, Botulinum toxin A, Bulkamid
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Botox
Intravesical injections of Botulinum toxin A (Botox) into the bladder wall.
Polyacrylamide hydrogelDevice
Also called Bulkamid
Midurethral injections of the bulking Agent Bulkamid into the submucosal tissues of the urethra.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rates for stress urinary incontinence (SUI)
Number of participants with negative cough stress test and 90 % improved SUI-visual analog scale.
Measured: 6 months
Change from baseline in number of micturitions per day
Measured: Baseline, 6 months
Secondary outcomes (8)
Frequency of complications
Measured: intra-operative and post-operative follow-up up to 12 months
Frequency of cough stress test levels
3 Levels: negative, only a few drops of urine, severe loss of urine
Measured: Baseline, 6 months, 12 months
SUI-visual analog scale
Scale from 0-10: 0-no suffering - 10-severe suffering
Measured: Baseline, 6 months, 12 months
UUI-visual analog scale
Scale from 0-10: 0-no suffering - 10-severe suffering
Measured: Baseline, 6 months, 12 months
Change from baseline in number of micturitions per day
Measured: Baseline, 6 months, 12 months
Change from baseline in number of urgency episodes per day
Measured: Baseline, 6 months, 12 months
Change from baseline in number of urgency urinary incontinence episodes per 3 days
Measured: Baseline, 6 months, 12 months
Change from baseline in urine volume per micturition
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mixed Incontinence, Urge and StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Volker Viereck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. Volker Viereck, Cantonal Hospital, Frauenfeld
- Investigators
- Volker Viereck, MD, Principal investigator, Cantonal Hospital, Frauenfeld
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815046
- Sponsor's protocol ID
- Botox-Bulkamid study
- Status last verified
- Mar 2020
- First submitted
- 8 Jun 2016
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Publication in peer-reviewed journal
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02815046
- Acronym / sponsor ID
- Botox-Bulkamid study
- Conditions
- Mixed Incontinence, Urge and Stress
- Keywords
- urgency urinary incontinence, stress urinary incontinence, Botulinum toxin A, Bulkamid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Prof. Dr. Volker ViereckUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with mixed urinary incontinence (MUI) eligible for an intervention with Botox and Bulkamid.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type AAlso: BotoxIntravesical injections of Botulinum toxin A (Botox) into the bladder wall. | Drug | – |
| Polyacrylamide hydrogelAlso: BulkamidMidurethral injections of the bulking Agent Bulkamid into the submucosal tissues of the urethra. | Device | – |
Primary outcome
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
8 secondary outcomes
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
SUI-visual analog scale
Time frame: Baseline, 6 months, 12 months
UUI-visual analog scale
Time frame: Baseline, 6 months, 12 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Individual participant dataSharing planned: Yes. Publication in peer-reviewed journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Volker Viereck, MD principal investigator
Cantonal Hospital, Frauenfeld
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mixed Incontinence, Urge and Stress, run by Prof. Dr. Volker Viereck at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rates for stress urinary incontinence (SUI) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.