Butterfly Pivotal Study

Lower Urinary Tract Symptoms (LUTS) Clinical Trial

Official title:

A Prospective, Randomized, Controlled, Blinded Study to Assess the Safety and Efficacy of the Butterfly Medical Prostatic Retraction Device in BPH Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05341661
• Other study ID #: CL-BM14-001
• Status: Recruiting
• Phase: N/A
• Start date: April 7, 2022
• Est. completion date: March 1, 2028

Study information

• Verified date: May 2023
• Source: Butterfly Medical Ltd.
• Contact: Vardit Segal, Ph.D.
• Phone: +972524579178
• Email: vardit[@]butterfly-medical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective, multicenter, blind randomized (2:1) controlled study comparing the International Prostate Symptom Score (IPSS) of the Active arm to the IPSS of the control arm at the 3 months follow-up and active arm IPSS score change from time zero to 12 months. Patients in the active arm undergo Butterfly device treatment. Patients in the control arm undergo a sham rigid cystoscopy procedure

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 222
• Est. completion date: March 1, 2028
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Male patient age 50 to 80

2. Willing and able to sign informed consent

3. Willing and able to comply with all study assessments

4. Prostate length of 25mm-45mm (from apex of the prostate to the beginning of the bladder neck).

5. Prostate volume 30-90 ml

6. Symptomatic BPH: IPSS = 13; = 1 in the IPSS voiding to sub-score ratio (IPSS-V/S)

Exclusion Criteria:

1. Known sensitivity to Nickel.

2. Current urinary retention

3. Urinary stress incontinence (sphincter)

4. Biopsy of the prostate within the last 6 weeks

5. Baseline PSA > 10 ng/mL or confirmed or suspected prostate cancer. Patients with a PSA level above 2.5 ng/mL, in which free PSA is < 25% of total PSA in whom cancer was not ruled out by biopsy.

6. Chronic prostatitis, recurrent prostatitis, chronic pelvic pain syndrome (CPPS), or painful bladder syndrome within the past 12 months

7. Obstructing intraprostatic median lobe (e.g., more than 10mm intravesical prostatic protrusion).

8. Urethral stricture, meatal stenosis, or bladder neck stricture - either current or recurrent.

9. Anatomical anomalies that will not accommodate the retractor, as determined by cystoscopy (e.g., prostatic urethral length to height geometry, absence of bladder neck)

10. Prior surgery or minimal invasive procedure of prostate (brachytherapy and PAE patients are not excluded if they show significant obstruction in urodynamic test and cystoscopy shows no significant fibrosis).

11. Currently active bladder tumor or intravesical instillation.

12. History of other diseases causing voiding dysfunction including urinary retention (e.g., uncontrolled diabetes, diagnosis of neurogenic or atonic bladder, Parkinson's disease, multiple sclerosis, etc.).

13. Suspected Neurogenic or atonic urinary bladder.

14. Suspected Polyuria/Nocturnal Polyuria.

15. Suspected overactive bladder

16. High bladder neck with the absence of lateral lobe encroachment indicating a high likelihood of primary bladder neck obstruction as determined by the Investigator

17. Urethral pathology: diverticula, strictures, tumors, fistula.

18. Acute clinically Significant urinary tract infection.

19. Uncontrolled bleeding disorders.

20. Active stone disease (urinary stone increase in size during the last 3 months/ stone passage during the last 3 months/ presence of cystolithiasis)

21. Taking 5 alpha reductase inhibitors within 6 months of baseline evaluation

22. Taking one of the following within 2 weeks of baseline evaluation:

1. alpha-blockers,

2. imipramine,

3. anticholinergics,

4. Phosphodiesterase-5 Enzyme Inhibitors (Tadalafil) in doses for BPH,

5. Beta-3 adrenergic receptor agonist (Mirabegron),

23. Taking androgens, unless eugonadal state for at least 2 months or greater as documented by the Investigator

24. Taking Gonadotrophin releasing hormone analogues within 12 months of baseline evaluation

25. Taking one of the following within 24 hours of pre-treatment (baseline) evaluation:

phenylephrine, or, pseudoephedrine,

26. One of the following baseline test results, taken from a single uroflowmetry reading:

• Urinary volume void = 125mL (pre-bladder urinary volume of = 150 mL required),
• Peak urinary flow rate (Qmax) of = 5 ml/second and > 15 mL/second,
• Post- void residual volume (PVR) > 250 mL

27. Inmates, patient with physical, psychological (such as developmentally delayed adults), or medical impairment that might prevent study completion or would confound study results (including patient questionnaires) in the judgment of the Investigator

28. Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.

Related Conditions & MeSH terms

• BPH (Benign Prostatic Hyperplasia)
• Hyperplasia
• Lower Urinary Tract Symptoms
• Lower Urinary Tract Symptoms (LUTS)
• Prostatic Hyperplasia

Intervention

Device:
• Butterfly Prostatic Retraction Device
Implantation of the Butterfly device

Locations

Country	Name	City	State
United States	Manhattan Medical Research	New York	New York
United States	Summit Urology	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Butterfly Medical Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to month 3 in International Prostate Symptom Score (IPSS) Score.	Analysis will compare the active and control study arms IPSS	3 month
Primary	Change in active arm International Prostate Symptom Score (IPSS) from baseline to 12 months	Analysis will assess the IPSS percent change for the active arm compared to a baseline score	12 month