臨床研究等提出・公開システム

The utility of penile rehabilitation with vacuum constriction device after performing brachytherapy for prostate cancer. (VIGOR Study)

VIGOR Study

Onishi Kenta

Nara medical university Hospital

840 Shijo-Cho, Kashihara, Nara, Japan

k-onishi0912@naramed-u.ac.jp

Onishi Kenta

Nara medical university Hospital

840 Shijo-Cho, Kashihara, Nara, Japan

+81-744-22-3051

k-onishi0912@naramed-u.ac.jp

Recruiting

Sept. 28, 2023

Interventional

single arm study

open(masking not used)

historical control

single assignment

prevention purpose

1) Disease: Prostate cancer
2) Stage: Stage 1-2
3) Age: 20-75 years old
4) Gender: Male
5) ECOG PS (Performance Status) 0-1
6) Mild to moderately preserved sexual function before brachytherapy (SHIM more than 12 points)
7) Patients treated with brachytherapy alone
8) Patients planning to have sexual intercourse before or after surgery
9) Patients who have given written consent to participate in this clinical study

1) Patients with cognitive impairment
2) Patients with poorly controlled diabetes mellitus (HbA1c of 10% or higher)
3) Patients with neurological disease
4) Patients undergoing adjuvant hormonal therapy (surgical castration or medical castration) for brachytherapy
5) Patients receiving external radiation therapy as adjuvant therapy to brachytherapy
6) Patients taking PDE5 inhibitors
7) Patients using vacuum constriction device
8) Patients on antithrombotic therapy or predisposed to bleeding
9) Patients who have difficulty operating vacuum constriction device
10) Patients who are deemed inappropriate as research subjects by the principal investigator or subinvestigator

Male

Stage: Stage I-II

Use of a vacuum constriction device for 15 minutes once every 2 days beginning at the time of urethral catheter removal after brachytherapy.

prostate cancer

vacuum constriction device

PC

PC

SHIM score at 6 months after brachytherapy

SHIM score at 1 month and 3 months after brachytherapy
Quality of life at 1 month, 3 months after after brachytherapy, and at the end of intervention (6 months after after brachytherapy)
Change in penile blood flow before after brachytherapy, after 1 month , after 3 months of after brachytherapy, and at the end of intervention (after 6 months of brachytherapy)
Change in penile length and penile circumference before and 1 month , 3 months after brachytherapy, and at the end of intervention (6 months after brachytherapy)
Change in testosterone levels and body composition before and 1 month , 3 months after brachytherapy, and at the end of the intervention (6 months after brachytherapy)
Change in Pittsburgh Sleep Quality Index global score (PSQIG) before and 3 months after brachytherapy
Change in nocturia after 1 month, 3 months after brachytherapy, and at the end of intervention (after 6 months brachytherapy)

+81-744-29-8835

Sept. 25, 2023

No

none