Comparison of reduction effect on storage symptom between tadalafil and silodosin in men with benign prostate hyperplasia: A prospective randomized crossover study

Comparison of reduction effect on storage symptom between tadalafil and silodosin in men with benign prostate hyperplasia: A prospective randomized crossover study - The RESTORE study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024578

Enrollment

Registered

2016-12-20

Start date

2016-12-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign prostate hyperplasia

Interventions

We will administer tadalafil 5mg/day for 8 weeks first and silodosin 8mg/day for 8 weeks second. We will administer silodosin 8mg/day for 8 weeks first and tadalafil 5mg/day for 8 weeks second.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Prostate volume is 20 mL and over. - OABSS is 6 and over.

Exclusion criteria

Exclusion criteria: - Prostate cancer - Neurogenic bladder - Under treatment with alpha1 blockers and/or OAB drugs - Contraindication of tadalafil

Design outcomes

Primary

Measure	Time frame
Variations of overacrive bladder symptom score (OABSS) at 8-week after the administration of each drug	—

Secondary

Measure	Time frame
Variations of the items below at 4-week and 8-week after the administraion of each drug - International prostate symptom score (IPSS): Total score, Storage subscore, and Voiding subscore - International Index of Erectile Function (IIEF) - Maximum urinary flow rate - Post-void residual urine - Mean voided volume - Blood pressure on visits	—

Countries

Japan

Contacts

Public ContactKazumasa Torimoto

Nara Medical University Hospital Urology

torimoto@naramed-u.ac.jp+81-744-22-3051

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026