Clinical trial NCT02815046: Mixed Urinary Incontinence Symptoms Before and After Treatment With Botox and Bulkamid
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mixed Incontinence, Urge and Stress
Keywords: urgency urinary incontinence
stress urinary incontinence
Botulinum toxin A
Bulkamid
Lead sponsor: Cantonal Hospital, Frauenfeld
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with mixed urinary incontinence (MUI) eligible for an intervention with Botox and Bulkamid.

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.


Eligibility 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

Primary outcomes:
measure: Cure rates for stress urinary incontinence (SUI)
timeFrame: 6 months
measure: Change from baseline in number of micturitions per day
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Frequency of complications
timeFrame: intra-operative and post-operative follow-up up to 12 months
measure: Frequency of cough stress test levels
timeFrame: Baseline, 6 months, 12 months
measure: SUI-visual analog scale
timeFrame: Baseline, 6 months, 12 months
measure: UUI-visual analog scale
timeFrame: Baseline, 6 months, 12 months
measure: Change from baseline in number of micturitions per day
timeFrame: Baseline, 6 months, 12 months
measure: Change from baseline in number of urgency episodes per day
timeFrame: Baseline, 6 months, 12 months
measure: Change from baseline in number of urgency urinary incontinence episodes per 3 days
timeFrame: Baseline, 6 months, 12 months
measure: Change from baseline in urine volume per micturition
timeFrame: Baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Frauenfeld
country: Switzerland
facility: Cantonal Hospital Frauenfeld
Study officials:
affiliation: Cantonal Hospital, Frauenfeld
name: Volker Viereck, MD
role: PRINCIPAL_INVESTIGATOR
References: