Pilot study of dMD-002 in patients with neurovascular bundles injury during radical prostatectomy -

JRCT ID: jRCT2022210040

Registered date:01/10/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Prostate cancer
• Date of first enrollment: 01/10/2021
• Target sample size: 12
• Study type: Interventional
• Intervention(s): The cut dMD-002 is implanted to cover the nerve injury, tear, or defect, and is fixed by suturing to the surrounding tissue in two or more places.

Outcome(s)

Primary Outcome

Efficacy
Change in EHS
Change in IIEF EF
Change in EPIC sxual function(Q17 to 23)

Safety
Advere event
defect

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Male

Include criteria

(1) Patients diagnosed with prostate cancer
(2) Patients scheduled for radical prostatectomy (non-nerve sparing or unilateral nerve-sparing) by robot-assisted laparoscopic surgery
etc.

Exclude criteria

(1) Patients required radiation therapy, endocrine therapy or antineoplastic therapy before or after radical prostatectomy
(2) Patients taking PDE5 inhibitors
(3) Patients using negative pressure erection apparatus

Related Information

• Primary Sponsor: Nakamura Masaki
• Source(s) of Monetary Support: Sponsored research