CClinicalTrials.gg
Status unknownNCT01838486ICUpdated Apr 24, 2013

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

An interventional study of Bladder Thermal Distention in Interstitial Cystitis and Painful Bladder Syndrome, sponsored by Assaf-Harofeh Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-04-24.

Sponsored by Assaf-Harofeh Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Interstitial Cystitis
  • Painful Bladder Syndrome

Keywords

  • Interstitial cystitis
  • painful bladder syndrome
  • bladder hydrodistention
  • hyperthermia
03

In context

Cystitis

235 studies on the registry are indexed under Cystitis; 22 are open to participants now.

This study's planned enrollment of 20 is below the median of 60 across 170 interventional studies indexed under Cystitis.

Browse Cystitis studies →

Lead sponsor

Assaf-Harofeh Medical Center is the lead sponsor of 258 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Active infection
  • Urethral stricture
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Bladder Thermal Distention (BTD)

    Continuous irrigation of the bladder with warm saline (up to 45 Celsius) using the PelvixTT system

    Procedure: Bladder Thermal Distention

Interventions

  • ProcedureBladder Thermal Distention

    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.

    Also known as: PelvixTT - Hyperthermia Elmedical LTD, Israel

06

What researchers measure

Primary outcomes

  1. o'leary sant questionnaire

    o'leary sant questionnaire is a validated specific tool for evaluation of IC/PBS symptoms

    Time frame: up to 1 year

Secondary outcomes

  1. Bladder diary

    symptoms like urgency. frequency and functional voided volumes will be monitored

    Time frame: up to 1 year

07

Study locations

1 of 1 sites recruiting
  • Assaf Harofe Medical Center
    Zerifin, 70300, Israel
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01838486
Lead sponsor
Assaf-Harofeh Medical Center
Responsible party
Sponsor
First posted
Apr 24, 2013
Start date
Jun 2012
Primary completion
Apr 2014 (estimated)
Completion
Apr 2014 (estimated)
Last update
Apr 24, 2013

Study contacts

Kobi Stav, MD
Contact
stavkobi@gmail.com
972-8-9779409
Kobi Stav, MD
principal investigator · Assaf Harofe Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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