Interstitial CystitisICNCT01838486
Bladder Thermal Distention for Patients With Interstitial Cystitis / Painful Bladder Syndrome
A study testing Bladder Thermal Distention in people with Interstitial Cystitis and Painful Bladder Syndrome, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Patients with Interstitial Cystitis / PBS will be treated with bladder thermal distention (BTD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Cystitis, Painful Bladder Syndrome
- 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
- Jun 2012to 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
- -All patients with interstitial cystitis / painful bladder syndrome (IC/PBS) who had previous intravesical treatment with DMSO
Who cannot join
- Active infection
- Urethral stricture
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assaf Harofe Medical Center
Tsrifin, 70300
Kobi Stav, MD, stavkobi@gmail.com
Kobi Stav, MD
About this study
Patients with Interstitial Cystitis / PBS will be treated with bladder thermal distention (BTD).
Read the detailed description
In this study we will evaluate the efficacy of bladder thermal distention (BTD) in patients with IC/PBS.
Patients with previous failed conventional treatment (intravesical DMSO) will be recruited.
- Conditions
- Interstitial Cystitis, Painful Bladder Syndrome
- Being tested
- Bladder Thermal Distention
- Keywords
- Interstitial cystitis, painful bladder syndrome, bladder hydrodistention, hyperthermia
- Medical subject headings
- Cystitis, Interstitial, Hyperthermia
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 (BTD) is an approved procedure in Europe and Israel. Continuous irrigation of the bladder with warm saline with the PelvixTT system. The procedure will be performed on an outpatients basis. The procedure lasts 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Bladder Thermal Distention (BTD) | Experimental | Continuous irrigation of the bladder with warm saline (up to 45 Celsius) using 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.
o'leary sant questionnaire
o'leary sant questionnaire is a validated specific tool for evaluation of IC/PBS symptoms
Measured: up to 1 year
Secondary outcomes (1)
Bladder diary
symptoms like urgency. frequency and functional voided volumes will be monitored
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 posted24 Apr 2013 (estimated)
- Study startJun 2012
- Primary completionApr 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 Interstitial CystitisStudies 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 Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838486
- Sponsor's protocol ID
- 37/12
- Acronym
- IC
- Status last verified
- Apr 2013
- First submitted
- 19 Apr 2013
- Last updated
- 24 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bladder Thermal Distention for Patients With Interstitial Cystitis / Painful Bladder Syndrome
- ClinicalTrials.gov ID
- NCT01838486
- Acronym / sponsor ID
- IC / 37/12
- Conditions
- Interstitial Cystitis, Painful Bladder Syndrome
- Keywords
- Interstitial cystitis, painful bladder syndrome, bladder hydrodistention, hyperthermia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Jun 2012
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 24 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.
Patients with Interstitial Cystitis / PBS will be treated with bladder thermal distention (BTD).
Detailed description
In this study we will evaluate the efficacy of bladder thermal distention (BTD) in patients with IC/PBS.
Patients with previous failed conventional treatment (intravesical DMSO) will be recruited.
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 (BTD) | Experimental | Procedure: Bladder Thermal DistentionContinuous irrigation of the bladder with warm saline (up to 45 Celsius) using 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 (1 listed)
- -All patients with interstitial cystitis / painful bladder syndrome (IC/PBS) who had previous intravesical treatment with DMSO
Key exclusion criteria (2 listed)
- Active 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 (BTD) is an approved procedure in Europe and Israel. Continuous irrigation of the bladder with warm saline with the PelvixTT system. The procedure will be performed on an outpatients basis. The procedure lasts 1 hour. | Procedure or surgery | Bladder Thermal Distention (BTD) |
Primary outcome
o'leary sant questionnaire
Time frame: up to 1 year
o'leary sant questionnaire is a validated specific tool for evaluation of IC/PBS symptoms
1 secondary outcome
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 24 Apr 2013.
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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.
Kobi Stav, MD principal investigator
Assaf Harofe Medical Center
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 Interstitial Cystitis and Painful Bladder Syndrome, 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 1 inclusion and 2 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 24 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 (972-8-9779409, stavkobi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
o'leary sant 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 24 Apr 2013.