CompletedNot Applicable

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

Switzerland58 participantsStarted 2016-08

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cure rates for stress urinary incontinence (SUI)

Timeframe: 6 months

Change from baseline in number of micturitions per day

Timeframe: Baseline, 6 months

Trial details

NCT IDNCT02815046

SponsorProf. Dr. Volker Viereck

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-12

View on ClinicalTrials.gov More Mixed Incontinence, Urge and Stress trials