Overactive Bladder
Conditions
Keywords
Overactive Bladder, Bladder Distention
Brief summary
In this study, the investigators will evaluate the efficacy of Bladder Thermal Distention (BTD) in patients with overactive bladder syndrome who failed previous treatment of anticholinergic drugs. The investigators' hypothesis is that it will improve the storage symptoms.
Detailed description
Inclusion criteria: 1. Patients with overactive bladder syndrome 2. Detrusor Overactivity proven in urodynamic test Exclusion criteria: 1. Mixed urinary incontinence 2. Active urinary tract infection 3. Urethral Stricture Outcome measures: 1. Bladder Diaries 2. Urgency questionnaire
Interventions
PROCEDUREBladder Thermal Distention
Bladder Thermal Distention is an approved procedure in Europe from 2006. The treatment is hydrodistention of the bladder with a warm saline (up to 45C). The procedure lasts 1 hour. The saline is infused constantly through a 3 ways specific catheter (Unithermia 18F) by the PelvixTT system.
Sponsors
Assaf-Harofeh Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with overactive bladder syndrome * Detrusor Overactivity proven in urodynamic test
Exclusion criteria
* Mixed urinary incontinence * Active urinary tract infection * Urethral Stricture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urgency Questionnaire | up to 1 year | Patients will complete the validated USIQ questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily frequency of micturitions on Bladder Diary | up to 1 year | Patients will complete bladder diaries before and after the procedure. Frequencies of micturitions per day will be documented |
Countries
Israel
Contacts
Primary ContactKobi Stav, MD
Outcome results
None listed