Temperature Mapping of the Prostate With the Wallterm™ System (WT-DK-TMW08)

To measure intra-prostatic temperatures and evaluate the shape and size of necrotic lesions achieved under the standard treatment protocol in men with benign prostatic hyperplasia (BPH).

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Device: The Wallterm™ System

Detailed Description

The Wallterm System provides minimally invasive treatment of benign prostatic hyperplasia (BPH) via a high temperature, liquid filled, balloon thermotherapy. The catheter is composed of a silicone positioning balloon which anchors the catheter against the bladder neck. The multi-layer silicone treatment balloon may be adjusted to fit short (20-35mm) and long (40-55mm) prostates and is inflated (to approximately 650-700 mmHg / 20-22mm diameter) to ensure tight tissue contact and reduced blood perfusion. The handle contains the heating element and the liquid circulation mechanisms

• Study Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Herlev Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Men with BPH

Description

Inclusion Criteria:

• Men with symptomatic BPH requiring treatment,
• IPSS score > 15
• Age > 50 years
• Prostate size of 25 g or greater
• Prostatic urethra length between 2.0 cm and 5.5 cm,
• Ability to understand and consent to participate in this investigation,
• Willingness and ability to participate in all required follow-up evaluations.

Exclusion Criteria:

• Allergy towards Silicone,
• Peak Urinary Flow > 15 mL/s,
• Penile or urinary sphincter implant,
• Patients with active urinary tract infection indicated by a positive urinary culture >105 CFU (Note: These patients may be treated after successful treatment of the infection.)
• Clinical (historical), paraclinical (i.e. PSA> 10ng/mL) or histological evidence of prostatic cancer or bladder cancer,
• Evidence of a non-symmetric prostatic median lobe enlargement, or a prostatic lobe which is prominent with an obstructing "ball valve", as determined by cystoscopy or ultrasound,
• Patients with any previous prostate surgery, procedure for BPH, or any other invasive treatment to the prostate (such as TUR-P).
• Previous rectal surgery (Exception: hemorrhoid surgery), radical pelvic surgery or pelvic irradiation.
• Patients with confirmed or suspected bladder cancer.
• Patients with a history of cystolithiasis or bladder pathology, or who have experienced relapsing bacterial prostatitis within the last 6 months.
• Patients with gross haematuria. (Note: These patients may be eligible for this investigation if the results of a careful workup for cancer, including an X-ray study, cystoscopy and cytology, are found to be negative.)
• Patients with a history of bladder neck contracture.
• Patients who presently have urethral strictures, which prevent the passage of a 20 Fr endoscope (these patients may be treated after successful treatment of the stricture).
• Patients with neurogenic bladder dysfunction (neurogenic detrusor hypo- or hyperactivity).
• Patients interested in future fertility.
• Patients who have chronic catheter drainage due to urinary retention (these patients may be treated if a CMG demonstrates that the patient has a contractile bladder).
• Patients with bleeding disorders, or other systemic disorder contraindication minimally invasive surgical therapies.
• Any condition (ie: vascular clips) which would preclude an MRI from being performed, or otherwise confound this investigation.
• Patients with compromised renal function (i.e. serum creatinine >150 mls/l), renal or upper tract dilatation.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Symptomatic Benign Protate Hypertrophy; Symptom Score (IPSS) greater than 15, requiring invasive treatment, Prostate size greater than 25 g, Prostatic urethra length between 2.0 cm and 5.5 cm	Device: The Wallterm™ System; The Wallterm™ System is intended to ablate prostatic glandular and stromal tissue to relieve moderate to severe symptoms of outflow obstruction secondary to benign prostatic hyperplasia (BPH).; Other Names: Wallterm™ Catheter (model 3010); Wallterm™ Central Unit (model 3020-10)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the temperatures within the prostate using the Wallterm System	Assessed at primary treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess whether the Wallterm System delivers safe and consistent temperatures from base to apex; and determine the temperature range toward rectum, along the urethra.	Immediate
Delineate the extent and the location of necrosis	Short term

Collaborators and Investigators

• Sponsor: Pnn Medical A/S
• Investigators: Principal Investigator: Jørgen Nordling, Professor, Urological Dep., Herlev Hospital, Denmark

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: April 7, 2008
• First Submitted That Met QC Criteria: April 17, 2008
• First Posted (Estimate): April 21, 2008

Study Record Updates

• Last Update Posted (Estimate): February 4, 2010
• Last Update Submitted That Met QC Criteria: February 3, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: BPH
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: WT-DK-TMW08