Clinical trial NCT00662350: Temperature Mapping of the Prostate With the Wallterm™ System
Official title: Temperature Mapping of the Prostate With the Wallterm™ System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Prostatic Hyperplasia
Keywords: BPH
Lead sponsor: Pnn Medical A/S
Sponsor class: INDUSTRY
First posted: 2008-04-21
Enrollment: 6
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men with BPH

Brief summary: 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).

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

Eligibility criteria: 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.

Primary outcomes:
measure: To assess the temperatures within the prostate using the Wallterm System
timeFrame: Assessed at primary treatment
Secondary outcomes:
measure: 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.
timeFrame: Immediate
measure: Delineate the extent and the location of necrosis
timeFrame: Short term
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
affiliation: Urological Dep., Herlev Hospital, Denmark
name: Jørgen Nordling, Professor
role: PRINCIPAL_INVESTIGATOR
References: