WT-DK-TMW08: Temperature Mapping of the Prostate With the Wallterm™ System
Study Details
Study Description
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 | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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:
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Outcome Measures
Primary Outcome Measures
- To assess the temperatures within the prostate using the Wallterm System [Assessed at primary treatment]
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. [Immediate]
- Delineate the extent and the location of necrosis [Short term]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Men with symptomatic BPH requiring treatment,
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IPSS score > 15
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Age > 50 years
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Prostate size of 25 g or greater
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Prostatic urethra length between 2.0 cm and 5.5 cm,
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Ability to understand and consent to participate in this investigation,
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Willingness and ability to participate in all required follow-up evaluations.
Exclusion Criteria:
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Allergy towards Silicone,
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Peak Urinary Flow > 15 mL/s,
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Penile or urinary sphincter implant,
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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.)
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Clinical (historical), paraclinical (i.e. PSA> 10ng/mL) or histological evidence of prostatic cancer or bladder cancer,
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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,
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Patients with any previous prostate surgery, procedure for BPH, or any other invasive treatment to the prostate (such as TUR-P).
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Previous rectal surgery (Exception: hemorrhoid surgery), radical pelvic surgery or pelvic irradiation.
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Patients with confirmed or suspected bladder cancer.
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Patients with a history of cystolithiasis or bladder pathology, or who have experienced relapsing bacterial prostatitis within the last 6 months.
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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.)
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Patients with a history of bladder neck contracture.
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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).
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Patients with neurogenic bladder dysfunction (neurogenic detrusor hypo- or hyperactivity).
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Patients interested in future fertility.
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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).
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Patients with bleeding disorders, or other systemic disorder contraindication minimally invasive surgical therapies.
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Any condition (ie: vascular clips) which would preclude an MRI from being performed, or otherwise confound this investigation.
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Patients with compromised renal function (i.e. serum creatinine >150 mls/l), renal or upper tract dilatation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Herlev Hospital | Herlev | Denmark | 2730 |
Sponsors and Collaborators
- Pnn Medical A/S
Investigators
- Principal Investigator: Jørgen Nordling, Professor, Urological Dep., Herlev Hospital, Denmark
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WT-DK-TMW08