NCT01838486

Brief Summary

Patients with Interstitial Cystitis / PBS will be treated with bladder thermal distention (BTD).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 24, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 24, 2013

Status Verified

April 1, 2013

Enrollment Period

1.8 years

First QC Date

April 19, 2013

Last Update Submit

April 23, 2013

Conditions

Interstitial CystitisPainful Bladder Syndrome

Keywords

Interstitial cystitispainful bladder syndromebladder hydrodistentionhyperthermia

Outcome Measures

Primary Outcomes (1)

  • o'leary sant questionnaire

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

    up to 1 year

Secondary Outcomes (1)

  • Bladder diary

    up to 1 year

Study Arms (1)

Bladder Thermal Distention (BTD)

EXPERIMENTAL

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

Procedure: Bladder Thermal Distention

Interventions

Bladder Thermal DistentionPROCEDURE

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
Bladder Thermal Distention (BTD)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Active infection
  • Urethral stricture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf Harofe Medical Center

Ẕerifin, 70300, Israel

RECRUITING

MeSH Terms

Conditions

Cystitis, InterstitialHyperthermia

Condition Hierarchy (Ancestors)

CystitisUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and Injuries

Study Officials

  • Kobi Stav, MD

    Assaf Harofe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kobi Stav, MD

CONTACT

972-8-9779409stavkobi@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2013

First Posted

April 24, 2013

Study Start

June 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 24, 2013

Record last verified: 2013-04

Locations

IL(1)