Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01912339
Other study ID # 2105-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2013
Est. completion date October 17, 2016

Study information

Verified date April 2020
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the safety and efficacy of the Rezūm System and assess its effect on urinary symptoms secondary to benign prostatic hyperplasia (BPH).


Description:

This study is a prospective, controlled, randomized single blind clinical trial of subjects with benign prostatic hyperplasia, which will allow for an interim analysis for sample size adjustment. Subjects first will be randomized in a 2:1 proportion in favor of the Treatment arm. Subjects in the Control arm will be allowed to crossover to have the Rezūm treatment after the 3-month follow-up examination.


Recruitment information / eligibility

Status Completed
Enrollment 197
Est. completion date October 17, 2016
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Male
Age group 50 Years and older
Eligibility Inclusion Criteria:

1. Male subjects > 50 years of age who have symptomatic BPH.

2. International Prostate Symptom Score (IPSS) score = 13.

3. Peak urinary flow rate (Qmax): = 5ml/sec to = 15 ml/sec with minimum voided volume of = 125 ml.

4. Post-void residual (PVR) =250 ml.

5. Prostate volume > 30 and = 80 gm.

Exclusion Criteria:

1. History of clinically significant congestive heart failure (i.e. NYHA Class III and IV).

2. History of diabetes not controlled by a stable dose of medication over the past three months. Patients with a Hemoglobin A1c that is <8.0% are allowed.

3. History of significant respiratory disease where hospitalization for the disease is required.

4. History of immunosuppressive conditions (e.g., AIDS, post-transplant).

5. Cardiac arrhythmias that are not controlled by medication or medical device.

6. An episode of unstable angina pectoris, a myocardial infarction, transient ischemic attack, or a cerebrovascular accident within the past six months.

7. Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study.

8. Presence of a penile implant or stent(s) in the urethra or prostate.

9. Any prior invasive prostate intervention (e.g., radio frequency (RF) ablation, balloon, microwave, or laser) or other surgical interventions of the prostate.

10. Currently enrolled in any other pre-approval investigational study in the USA (does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints (e.g., limit use of study-required medication, etc.)).

11. History of confirmed malignancy or cancer of prostate or bladder, however, high grade PIN is acceptable.

12. History of cancer in non-genitourinary system that is not considered cured (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered cured if there has been no evidence of cancer within five years of randomization.

13. Previous pelvic irradiation or radical pelvic surgery.

14. Diagnosed with active Lyme Disease (borreliosis).

15. PSA > 10 ng/ml unless prostate cancer is ruled out by biopsy. If PSA is > 2.5 ng/ml and = 10 ng/ml with free PSA <25%, prostate cancer for the subject must be/had been ruled out through a negative biopsy prior to enrollment.

16. Has undergone prostate biopsy within 60 days prior to treatment date or has an imminent need for surgery.

17. Previous rectal surgery (other than hemorrhoidectomy) or known history of rectal disease.

18. Active urinary tract infection by culture within 7 days of treatment or two documented independent urinary tract infections of any type in the past 6 months.

19. Verified bacterial prostatitis within last 12 months documented by culture or non-bacterial prostatitis within the last 5 years.

20. Active or history of epididymitis within the past 3 months.

21. Neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function.

22. Diagnosed or suspected primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function, sphincter function or poor detrusor muscle function.

23. Urethral strictures, bladder neck contracture, unusual anatomy or muscle spasms that would prevent the introduction and use of the device.

24. Diagnosed bladder, urethral or ureteral stones or active stone passage in the past 6 months. Stones that are known to be in the kidney and have been stable for a period exceeding 3 months are permissible.

25. Post-void residual (PVR) > 250 ml.

26. Diagnosed or suspected bleeding disorder, or coagulopathies.

27. Use of antiplatelet or anticoagulant medication except low dose aspirin (=81 mg/day) within 10 days prior to treatment.

28. Visible hematuria with subject urine sample without a known contributing factor.

29. Subject interested in maintaining fertility.

30. Use of beta-blockers, anticonvulsants, and antispasmodics where the dose is not stable. (Stable dose is defined as having the same medication and dose in the last six months).

31. At the time of baseline assessment, in the absence of a qualifying exception, subjects who are using or have used the following medications, and are unable or unwilling to discontinue using these medications for the prescribed washout period:

1. Use of antihistamines within 1 week of treatment unless there is documented evidence of stable dosing for last 6 months (no dose changes).

2. Use of the alpha blockers for BPH and anticholinergics or cholinergics (except for topical anti cholinergic eye drops), or within 4 weeks of baseline assessment.

3. Use of Type II, 5-alpha reductase inhibitor (e.g., finasteride (Proscar, Propecia) within 3 months of baseline assessment.

4. Use of a dual 5-alpha reductase inhibitor (e.g., dutasteride (Avodart)) within 6 months of baseline assessment.

5. Use of estrogen, drug-producing androgen suppression, or anabolic steroids within 3 months of baseline assessment.

6. Use of daily dose PD5 Inhibitors (e.g.Viagra, Levitra or Cialis) within 4 weeks of baseline assessment.

32. Subjects who have had an incidence of spontaneous urinary retention either treated with indwelling transurethral catheter or suprapubic catheter six months prior to baseline. A provoked episode now resolved is still admissible.

33. Compromised renal function defined as serum creatinine > 2.0 mg/dl.

34. Inability to provide a legally effective Informed Consent Form (ICF) and/or comply with all the required follow-up requirements.

35. Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affect the ability to complete the study quality of life questionnaires.

Study Design


Intervention

Device:
Rezum System
The Rezum System uses sterile water vapor (steam) to treat BPH by delivering targeted, controlled doses of stored thermal energy directly to the transition zone of the prostate gland. A narrow sheath, similar in shape and size to a cystoscope, is inserted transurethrally and positioned within the prostatic urethra between the bladder neck and the verumontanum. A thin needle is deployed through the urethra into the transition zone, and a very short (8-10 second) treatment of water vapor is delivered directly into the hyperplastic tissue and immediately disperses through the tissue interstices. Upon contact with the tissue, the vapor condenses, or phase shifts, into its liquid state, releasing the stored thermal energy contained within the vapor. This thermal energy is released directly against the walls of the tissue cells within the treatment zone, gently and immediately denaturing the cell membranes, thereby causing instantaneous cell death.
Procedure:
Rigid Cystoscopy
Endoscopy of the urinary bladder via the urethra.

Locations

Country Name City State
United States South Florida Medical Research Aventura Florida
United States Texas Urology Carrollton Texas
United States The Urology Group Cincinnati Ohio
United States Cleveland Clinic Cleveland Ohio
United States UT Southwestern Dallas Texas
United States Urology Associates of Denver Denver Colorado
United States Carolina Urologic Research Center Myrtle Beach South Carolina
United States Manhattan Medical Research New York New York
United States Mayo Clinic Rochester Minnesota
United States Jean Brown Research Salt Lake City Utah
United States Urology of San Antonio San Antonio Texas
United States Southern Illinois University Springfield Illinois
United States Chesapeake Urology Towson Maryland
United States Arizona Institute of Urology Tucson Arizona
United States Metro Urology Woodbury Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy: Change From Baseline in the International Prostate Symptom Score (IPSS) at 3 Month Follow-Up Comparison of the change in BPH symptoms as measured by IPSS change between the Treatment and Control arm at 3 months post-treatment. The IPSS is a well-validated, highly reliable and responsive American Urological Association symptom score (AUASS) assessment to identify the severity of BPH Symptoms. The first seven questions of the IPSS Questionnaire address frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying and urgency each on a scale of 0 to 5. The total score, summed across the seven items measured, ranges from 0 (no symptoms) to 35 (most severe symptoms). 3 Month Follow-up Visit
Primary Safety: Device Related Serious Complications This safety endpoint will be to demonstrate that the composite observed rate of post-procedure device related serious complications in the Treatment Arm are is less than or equal to 12% at 3 months.
Composite device related serious complications for this endpoint are 1) De Novo (new) severe urinary retention lasting more than 21 consecutive days post treatment, 2) Device related formation of fistula between the rectum and urethra, and 3) device perforation of the rectum or GI tract. Twelve percent was a pre-specified performance goal for the safety endpoint.
3 Months
Secondary Responders at 3 Months Number of subjects with a greater than or equal to 30% improvement (reduction) in the International Prostate Symptom score (IPSS) at 3 months compared to baseline. 3 Months
Secondary Responders at 6 Months Number of subjects with a greater than or equal to 30% improvement (reduction) in the International Prostate Symptom score (IPSS) at 6 months compared to baseline. 6 Months
Secondary Responders at 12 Months Number of subjects with a greater than or equal to 30% improvement (reduction) in the International Prostate Symptom score (IPSS) at 12 months compared to baseline. 12 Months
See also
  Status Clinical Trial Phase
Recruiting NCT04807296 - Thulium Fiber Laser Enucleation of the Prostate (TFLEP) vs HoLEP With Moses Technology (m-HoLEP) N/A
Recruiting NCT05574244 - Comparison of Functional Outcomes of Ejaculation-preserving Partial Trans Urethral Resection of the Prostate With Complete Trans Urethral Resection of the Prostate for Benign Prostatic Obstruction N/A
Recruiting NCT04288427 - 5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy N/A
Not yet recruiting NCT04245566 - Prostatic Artery Embolization vs. Pharmacotherapy for LUTS/BPH Phase 3
Withdrawn NCT01967251 - Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction Phase 2
Completed NCT02509975 - Safety and Efficacy of OCL 503 in Prostate Artery Embolization N/A
Completed NCT03246880 - Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients Phase 3
Completed NCT02283684 - GreenLight Laser Photoselective Vaporization of the Prostate vs Bipolar Transurethral Vaporization of the Prostate; RCT Phase 4
Completed NCT02206243 - Embozene® Microspheres for Prostatic Arterial Embolization in Patients With Symptomatic Benign Prostatic Hyperplasia
Completed NCT01454349 - Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH) Phase 1/Phase 2
Completed NCT01438775 - Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) Phase 3
Completed NCT01139762 - A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms Phase 3
Completed NCT01152190 - A Study in Benign Prostatic Hyperplasia Phase 3
Active, not recruiting NCT00400894 - Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma N/A
Unknown status NCT00381108 - Study of the Effects of Pomegranate Tablets on Enlarged Prostates Phase 1
Completed NCT00224133 - The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months Phase 3
Completed NCT00701779 - Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia Phase 4
Terminated NCT02962674 - To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH. N/A
Active, not recruiting NCT05415748 - Deprescribing Tamsulosin in Older Men Phase 4
Recruiting NCT04853914 - Evaluation of the Safety of the Treatment of Benign Prostatic Hyperplasia by High Intensity Focused Ultrasound. N/A