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Bladder Thermal Distention for Patients With Interstitial Cystitis / Painful Bladder Syndrome

Bladder Thermal Distention for Patients With Interstitial Cystitis / Painful Bladder Syndrome

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01838486
Acronym
IC
Enrollment
20
Registered
2013-04-24
Start date
2012-06-30
Completion date
2014-04-30
Last updated
2013-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Cystitis, Painful Bladder Syndrome

Keywords

Interstitial cystitis, painful bladder syndrome, bladder hydrodistention, hyperthermia

Brief summary

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.

Interventions

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.

Sponsors

Assaf-Harofeh Medical Center
Lead SponsorOTHER_GOV

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

-All patients with interstitial cystitis / painful bladder syndrome (IC/PBS) who had previous intravesical treatment with DMSO

Exclusion criteria

* Active infection * Urethral stricture

Design outcomes

Primary

MeasureTime frameDescription
o'leary sant questionnaireup to 1 yearo'leary sant questionnaire is a validated specific tool for evaluation of IC/PBS symptoms

Secondary

MeasureTime frameDescription
Bladder diaryup to 1 yearsymptoms like urgency. frequency and functional voided volumes will be monitored

Countries

Israel

Contacts

Primary ContactKobi Stav, MD
stavkobi@gmail.com972-8-9779409

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026