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

Shamir Medical Center (Assaf-Harofeh)

Status: Unknown

Conditions: Overactive Bladder

Treatments: Procedure: Bladder Thermal Distention

Study type: Interventional

Funder types: Other

Identifiers

NCT01842685

216/12

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)

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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