NCT01842685

Brief 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.

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 Apr 2013

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 30, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 30, 2013

Status Verified

April 1, 2013

Enrollment Period

11 months

First QC Date

April 14, 2013

Last Update Submit

April 25, 2013

Conditions

Overactive Bladder

Keywords

Overactive BladderBladder Distention

Outcome Measures

Primary Outcomes (1)

  • Urgency Questionnaire

    Patients will complete the validated USIQ questionnaire

    up to 1 year

Secondary Outcomes (1)

  • Daily frequency of micturitions on Bladder Diary

    up to 1 year

Study Arms (1)

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.

Procedure: Bladder Thermal Distention

Interventions

Bladder Thermal DistentionPROCEDURE

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.

Also known as: PelvixTT - Hyperthermia Elmedical LTD, Israel
Bladder Thermal Distention

Eligibility Criteria

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

You may qualify if:

  • Patients with overactive bladder syndrome
  • Detrusor Overactivity proven in urodynamic test

You may not qualify if:

  • Mixed urinary incontinence
  • Active urinary tract infection
  • Urethral Stricture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf Harofe MC

Tel Aviv Region, Zeriffin, 70300, Israel

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, OveractiveUrinary Retention

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrination Disorders

Study Officials

  • Kobi Stav, MD

    Assaf Harofe MC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kobi Stav, MD

CONTACT

972-8-9778461stavkobi@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 14, 2013

First Posted

April 30, 2013

Study Start

April 1, 2013

Primary Completion

March 1, 2014

Study Completion

April 1, 2014

Last Updated

April 30, 2013

Record last verified: 2013-04

Locations

IL(1)