Overactive BladderOABNCT01842685
Bladder Thermal Distention for Patients With Refractory Overactive Bladder
A study testing Bladder Thermal Distention in people with Overactive Bladder, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Bladder Thermal Distention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2013to Apr 2014
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with overactive bladder syndrome
- Detrusor Overactivity proven in urodynamic test
Who cannot join
- Mixed urinary incontinence
- Active urinary tract infection
- Urethral Stricture
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assaf Harofe MC
Tel Aviv Region, Zeriffin, 70300
Kobi Stav, MD, 972-8-9779400, stavkobi@gmail.com
Kobi Stav, MD
About this study
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.
Read the detailed description
Inclusion criteria:
- Patients with overactive bladder syndrome
- Detrusor Overactivity proven in urodynamic test
Exclusion criteria:
- Mixed urinary incontinence
- Active urinary tract infection
- Urethral Stricture
Outcome measures:
- Bladder Diaries
- Urgency questionnaire
- Conditions
- Overactive Bladder
- Being tested
- Bladder Thermal Distention
- Keywords
- Overactive Bladder, Bladder Distention
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder Thermal DistentionProcedure or surgery
Also called PelvixTT - Hyperthermia Elmedical LTD, Israel
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.
| Study group | Role | What they receive |
|---|---|---|
| Bladder Thermal Distention | Experimental | Continuous irrigation of the bladder with warm saline (up to 45 Celsius) using a specific 3 ways catheter. The procedure will last 1 hour. Saline will be irrigated by the PelvixTT system. Receives: Procedure: Bladder Thermal Distention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urgency Questionnaire
Patients will complete the validated USIQ questionnaire
Measured: up to 1 year
Secondary outcomes (1)
Daily frequency of micturitions on Bladder Diary
Patients will complete bladder diaries before and after the procedure. Frequencies of micturitions per day will be documented
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionMar 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kobi Stav, MD, Principal investigator, Assaf Harofe MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842685
- Sponsor's protocol ID
- 216/12
- Acronym
- OAB
- Status last verified
- Apr 2013
- First submitted
- 14 Apr 2013
- Last updated
- 30 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bladder Thermal Distention for Patients With Refractory Overactive Bladder
- ClinicalTrials.gov ID
- NCT01842685
- Acronym / sponsor ID
- OAB / 216/12
- Conditions
- Overactive Bladder
- Keywords
- Overactive Bladder, Bladder Distention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Apr 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 30 Apr 2013 (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.
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:
- Patients with overactive bladder syndrome
- Detrusor Overactivity proven in urodynamic test
Exclusion criteria:
- Mixed urinary incontinence
- Active urinary tract infection
- Urethral Stricture
Outcome measures:
- Bladder Diaries
- Urgency questionnaire
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bladder Thermal Distention | Experimental | Procedure: Bladder Thermal DistentionContinuous irrigation of the bladder with warm saline (up to 45 Celsius) using a specific 3 ways catheter. The procedure will last 1 hour. Saline will be irrigated by the PelvixTT system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with overactive bladder syndrome
- Detrusor Overactivity proven in urodynamic test
Key exclusion criteria (3 listed)
- Mixed urinary incontinence
- Active urinary tract infection
- Urethral Stricture
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 |
|---|---|---|
| Bladder Thermal DistentionAlso: PelvixTT - Hyperthermia Elmedical LTD, IsraelBladder 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. | Procedure or surgery | Bladder Thermal Distention |
Primary outcome
Urgency Questionnaire
Time frame: up to 1 year
Patients will complete the validated USIQ questionnaire
1 secondary outcome
Daily frequency of micturitions on Bladder Diary
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2013.
Related trials for Overactive Bladder
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Not yet recruitingPhase 4
Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
Overactive Bladder, Parkinson Disease
Recruiting
Ambulatory Long Length URodynamics Evaluation
Urology, Urinary Bladder, Overactive
RecruitingObservational study
Tensi+ European Post-Market Clinical Follow-Up
Overactive Bladder
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.
Kobi Stav, MD principal investigator
Assaf Harofe MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bladder Thermal Distention in people with Overactive Bladder, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 30 Apr 2013. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kobi Stav, MD (972-8-9778461, stavkobi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urgency Questionnaire (time frame: up to 1 year). 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 30 Apr 2013; AzTrials last refreshed its copy on 5 Nov 2026.