Clinical trial NCT02943070: Rezum I Pilot Study for Benign Prostatic Hyperplasia
Official title: NxThera Benign Prostatic Hyperplasia Rezum System Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Hyperplasia
Benign Prostatic Hyperplasia
Adenoma, Prostatic
Prostatic Adenoma
Prostatic Hyperplasia, Benign
Prostatic Hypertrophy
Prostatic Hypertrophy, Benign
Rezum
Keywords: Rezum
Water Vapor Ablation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2016-10-24
Enrollment: 50
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: International Prostate Symptom Score (IPSS) Change From Baseline
timeFrame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years
measure: Major Complications
timeFrame: 3 months
Secondary outcomes:
measure: Proportion of Responders - Responders With a ≥ 30% International Prostate Symptom Score (IPSS) Improvement
timeFrame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years
measure: Proportion of Responders - Responders With a ≥ 50% International Prostate Symptom Score (IPSS) Improvement
timeFrame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years
measure: Proportion of Responders - Responders With Improvement ≥ 8 Points in IPSS
timeFrame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years
measure: Uroflow Assessment - Change From Baseline in Peak Urinary Flow (Qmax)
timeFrame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years
measure: Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 30% From Baseline
timeFrame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years
measure: Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 3 ml/Sec
timeFrame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years
measure: Uroflow Assessment - Change in Post Void Residual (PVR) by Follow up Interval
timeFrame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years
measure: Change in Sexual Function - Erectile Function
timeFrame: 1 month, 3 months, 6 months, 1 year, annually to 5 years
measure: Change in Sexual Function - Retrograde Ejaculation
timeFrame: 1 Week post procedure, 1 Month post procedure, 3 Months post procedure
measure: International Prostate Symptom Score (IPSS) Assessment by Prostate Volume
timeFrame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years
measure: International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe
timeFrame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years
measure: International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS
timeFrame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years
measure: Procedural Pain Score
timeFrame: Day of treatment, 1 Day post procedure, 1 Week post procedure, 1 Month post procedure, 3 Months post procedure
measure: Quality of Life (QoL) - Change in QoL as Measured With the International Prostate Symptom Score (IPSS)
timeFrame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years
measure: Quality of Life (QoL) - Change in QoL as Measured With the Benign Prostatic Hyperplasia Impact Index (BPHII)
timeFrame: Baseline to 1 month, 3 months, 6 months, 1 year, then annually to 5 years
measure: Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L
timeFrame: 1 month, 3 months, 6 months, 1 year, then annually to 5 years
measure: Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Visual Analog Scale (VAS)
timeFrame: 1 month, 3 months, 6 months, 1 year, then annually to 5 years
measure: Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L
timeFrame: 1 month, 3 months, 6 months, 1 year, then annually to 5 years
measure: Subject Satisfaction - Satisfied With Overall Procedure
timeFrame: 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years
measure: Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family
timeFrame: 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years
measure: Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years
timeFrame: 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years
measure: Procedural Parameters - Procedure Time
timeFrame: Day of Procedure
measure: Procedural Parameters - Treatment Time
timeFrame: Day of Procedure
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: University Hospital
city: La Romana
country: Dominican Republic
facility: Clinica Canela
city: Stockholm
country: Sweden
facility: Urologcentrum
Study officials:
affiliation: Program Manager, Clinical Affairs, Boston Scientific
name: Kevin M Hagelin
role: STUDY_DIRECTOR
References: