Temperature Mapping of the Prostate With the Wallterm™ System - Full Text View

Sponsored by:	Pnn Medical A/S
Information provided by:	Pnn Medical A/S
ClinicalTrials.gov Identifier:	NCT00662350

Purpose

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).

Condition
Benign Prostatic Hyperplasia

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Temperature Mapping of the Prostate With the Wallterm™ System

Further study details as provided by Pnn Medical A/S:

Primary Outcome Measures:

To assess the temperatures within the prostate using the Wallterm System [ Time Frame: Assessed at primary treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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. [ Time Frame: Immediate ] [ Designated as safety issue: Yes ]
Delineate the extent and the location of necrosis [ Time Frame: Short term ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	7
Study Start Date:	June 2008
Study Completion Date:	July 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Men with symptomatic BPH (International Prostate Symptom Score (IPSS) score greater than 15) requiring invasive treatment, Prostate size greater than 25 g, and a Prostatic urethra length between 2.0 cm and 5.5 cm

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Men with BPH

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662350

Locations

Denmark
Herlev Hospital
Herlev, Denmark, 2730

Sponsors and Collaborators

Pnn Medical A/S

Investigators

Principal Investigator:

Jørgen Nordling, Professor, M.D.

Urological Dep., Herlev Hospital, Denmark

More Information

Responsible Party:	Pnn Medical ( Jacob Hyllested-Winge, M.D., VP, Director Clinical And Regulatory )
Study ID Numbers:	WT-DK-TMW08
Study First Received:	April 7, 2008
Last Updated:	August 4, 2008
ClinicalTrials.gov Identifier:	NCT00662350
Health Authority:	Denmark: Danish Medicines Agency; Denmark: Ethics Committee; Denmark: Danish Data Protection Agency

Keywords provided by Pnn Medical A/S:

BPH

Study placed in the following topic categories:

Hyperplasia
Prostatic Diseases
Prostatic Hyperplasia
Genital Diseases, Male

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009