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Bladder Thermal Distention for Patients With Refractory Overactive Bladder (OAB)

S

Shamir Medical Center (Assaf-Harofeh)

Status

Unknown

Conditions

Overactive Bladder

Treatments

Procedure: Bladder Thermal Distention

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full description

Inclusion criteria:

  1. Patients with overactive bladder syndrome
  2. Detrusor Overactivity proven in urodynamic test

Exclusion criteria:

  1. Mixed urinary incontinence
  2. Active urinary tract infection
  3. Urethral Stricture

Outcome measures:

  1. Bladder Diaries
  2. Urgency questionnaire

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Bladder Thermal Distention
Experimental group
Description:
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.
Treatment:
Procedure: Bladder Thermal Distention

Trial contacts and locations

1

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Central trial contact

Kobi Stav, MD

Data sourced from clinicaltrials.gov

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