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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00662350
Recruitment Status : Completed
First Posted : April 21, 2008
Last Update Posted : February 4, 2010
Information provided by:
Pnn Medical A/S

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).

Condition or disease Intervention/treatment
Benign Prostatic Hyperplasia 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
Actual Enrollment : 6 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Temperature Mapping of the Prostate With the Wallterm™ System
Study Start Date : June 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

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)

Primary Outcome Measures :
  1. To assess the temperatures within the prostate using the Wallterm System [ Time Frame: Assessed at primary treatment ]

Secondary Outcome Measures :
  1. 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 ]
  2. Delineate the extent and the location of necrosis [ Time Frame: Short term ]

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men with BPH

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00662350

Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Pnn Medical A/S
Principal Investigator: Jørgen Nordling, Professor Urological Dep., Herlev Hospital, Denmark

Responsible Party: Jacob Hyllested-Winge, M.D., VP, Director Clinical And Regulatory, Pnn Medical Identifier: NCT00662350     History of Changes
Other Study ID Numbers: WT-DK-TMW08
First Posted: April 21, 2008    Key Record Dates
Last Update Posted: February 4, 2010
Last Verified: February 2010

Keywords provided by Pnn Medical A/S:

Additional relevant MeSH terms:
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male