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Rezum I Pilot Study for BPH (Rezum Pilot)

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ClinicalTrials.gov Identifier: NCT02943070
Recruitment Status : Active, not recruiting
First Posted : October 24, 2016
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
NxThera Inc

Brief Summary:
Evaluate the safety and efficacy of the Rezum System for the treatment of BPH

Condition or disease Intervention/treatment Phase
Prostatic Hyperplasia Benign Prostatic Hyperplasia Adenoma, Prostatic Prostatic Adenoma Prostatic Hyperplasia, Benign Prostatic Hypertrophy Prostatic Hypertrophy, Benign Rezum Device: Rezum System Not Applicable

Detailed Description:
Prospective, non-randomized clinical trial of subjects with benign prostatic hyperplasia. The objective of the study are to 1) determine the safety and efficacy of the BPH Rezum System and assess its effect on urinary symptoms secondary to benign prostatic hyperplasia (BPH), and 2) further document the safety and post-operative effects of the Rezum System in the treatment of obstructive BPH.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NxThera Benign Prostatic Hyperplasia Rezum System Pilot Study
Study Start Date : March 2012
Actual Primary Completion Date : February 2013
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rezum Treatment
Patients received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia.
Device: Rezum System
The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Other Names:
  • Rezum Procedure
  • Rezum
  • Water Vapor Ablation
  • Rezum Delivery Device
  • Rezum Generator




Primary Outcome Measures :
  1. IPSS Improvement [ Time Frame: 3 months ]
    The change (improvement) from baseline in IPSS score.

  2. Major Complications [ Time Frame: 3 months ]

    Safety is assessed by the frequency of systemic and local serious device related complications and the occurrence of unanticipated device-related adverse effects during treatment and at follow-up, up to 30 days. Due to the nature of the device, any device-related AEs are expected to present themselves during the immediate peri-procedure period (30 days post procedure).

    The device related complications that will be compared for this safety endpoint are:

    1. Severe Urinary Retention (Retention ≥ 24 hours)
    2. Fistula between rectum and urethra
    3. Perforation of the rectum or GI tract
    4. New incidences of retrograde ejaculation


Secondary Outcome Measures :
  1. Proportion of Responders wth a ≥ 30% IPSS Iimprovement [ Time Frame: 3 months ]
    The proportion of responders in the treatment and control arms will be evaluated. A responder is defined as a subject with ≥ 30% improvement in BPH symptoms from baseline as measured by the IPSS4.

  2. Proportion of Responders wth a ≥ 50% IPSS Iimprovement [ Time Frame: 3 months ]
    Analysis will be provided for a proportion of subjects with improvement ≥ 50% from baseline at 1 week, 1 month, and 3 months

  3. Proportion of Responders with improvement ≥ 8 points in IPSS [ Time Frame: 3 months ]
    Analysis will be provided for proportion of subjects with improvement ≥ 8 points from baseline at 1 week, 1 month, and 3 months

  4. Change in Uroflow (Qmax) [ Time Frame: 1 year ]

    Change in Uroflow at 1 year

    • Peak urinary flow rate (Qmax)


  5. Change in Sexual Function [ Time Frame: 1 year ]

    This will be measured by the following:

    1. Erectile Function as Measured by the International Index of Erectile Function (IIEF)
    2. Retrograde ejaculation

  6. Procedural Pain Score [ Time Frame: 1 month ]
    Subject will be asked to evaluate the level of pain experienced during the procedure, and at 1 day, 1 week, and 1 month post treatment. Pain score will be measured using the Wong-Baker scale.

  7. Quality of Life [ Time Frame: 1 year ]
    QoL will be measured using the QoL question in the IPSS

  8. Subject Satisfaction [ Time Frame: 1 year ]

    This will be assessed using a study specific questionnaire to evaluate the subject's overall satisfaction of the procedure at 1 week, 1 month, 3 months, 6 months and 1 year.

    These will be measured as:

    • Proportion of subjects that are satisfied with the procedure overall
    • Proportion of subjects that would recommend this treatment to friends and families
    • Proportion of subjects that would undergo the same treatment if their symptoms were to recur after 5 years

  9. Procedural Parameters [ Time Frame: Day 1 ]
    • Procedure time : Time from Delivery Tool insertion to final Delivery Tool withdrawal



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male subjects > 45 years of age who have symptomatic / obstructive symptoms secondary to BPH requiring invasive intervention.
  2. IPSS score of ≥ 15.
  3. Qmax: Peak flow rate ≤ 15 ml/sec.
  4. Post-void residual (PVR) < 300 ml.
  5. Prostate transverse diameter > 30 mm.
  6. Prostate volume between 20 to 120 gm.
  7. Voided volume ≥ 125 mL
  8. Subject able to complete the study protocol in the opinion of the investigator.
  9. Life expectancy of at least one year.

Exclusion Criteria:

  1. History of any illness or surgery that may confound the results of the study or have risk to subject.
  2. Presence of a penile implant.
  3. Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave) or surgical intervention for the symptoms of BPH.
  4. Currently enrolled or has been enrolled in another trial in the past 30 days.
  5. Confirmed or suspected malignancy of prostate or bladder
  6. Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease.
  7. Previous pelvic irradiation or radical pelvic surgery.
  8. Documented active urinary tract infection by culture or bacterial prostatitis within last year documented by culture (UTI is defined as >100,000 colonies per ml urine from midstream clean catch or catherization specimen)
  9. Neurogenic bladder or sphincter abnormalities.
  10. Urethral strictures, bladder neck contracture or muscle spasms.
  11. Bleeding disorder or is currently on coumadin. (Note that use of anti-platelet medication is not an exclusion criteria.)
  12. Subjects interested in maintaining fertility.
  13. Use of concomitant medications to include the following:

    1. Use of, antihistamines, and antispasmodics within 1 week of treatment unless there is documented evidence stable dosing for last 6 months (no dose changes).
    2. Use of alpha blockers, androgens, or gonadotropin-releasing hormonal analogs within 2 weeks of treatment.
    3. Use of 5-alpha reductase inhibitor within the last 6 months
    4. Use of antidepressants, anticholinergics, anticonvulsants, and beta blockers unless there is documented evidence of stable dosing
  14. Subject is unable or unwilling to go through the "washout" period prior to treatment.
  15. Subject has chronic urinary retention.
  16. Post-void residual volume > 300 ml.
  17. Significant urge incontinence.
  18. Poor detrusor muscle function.
  19. Neurological disorders which might affect bladder or sphincter function.
  20. Urinary sphincter abnormalities.
  21. Bladder stones.
  22. Evidence of bacterial prostatitis or symptoms of epididymitis
  23. Renal impairment or serum creatinine > 2.0 mg/dl
  24. In the physician's opinion, subject cannot tolerate a cystoscopy procedure well.
  25. Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the required follow-up requirements.
  26. Any cognitive disorder that interferes with or precludes direct and accurate communication with the study investigator regarding the study.
  27. Peripheral arterial disease with intermittent claudication or Leriches Syndrome (i.e., claudication of the buttocks or perineum).
  28. Biopsy of prostate within 30 days of procedure.

Information from the National Library of Medicine

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 ClinicalTrials.gov identifier (NCT number): NCT02943070


Locations
Czech Republic
University Hospital
Brno, Czech Republic
Dominican Republic
Clinica Canela
La Romana, Dominican Republic
Sweden
Urologcentrum
Stockholm, Sweden
Sponsors and Collaborators
NxThera Inc
Investigators
Study Director: Cindy B Ogden Vice President, Clinical Affairs - NxThera, Inc.

Responsible Party: NxThera Inc
ClinicalTrials.gov Identifier: NCT02943070     History of Changes
Other Study ID Numbers: 1189-001
First Posted: October 24, 2016    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by NxThera Inc:
Rezum
Water Vapor Ablation

Additional relevant MeSH terms:
Hyperplasia
Adenoma
Prostatic Hyperplasia
Hypertrophy
Pathologic Processes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Prostatic Diseases
Genital Diseases, Male
Pathological Conditions, Anatomical