Temperature Mapping of the Prostate With the Wallterm™ System

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

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.