Skip to content

Improvement effect and safety of overactive bladder symptoms

Improvement effect and safety of overactive bladder symptoms by 5-amin olevulinic acid (5-ALA) intake; Double-blind randomized placebo-controlled trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs061220050
Enrollment
100
Registered
2022-08-29
Start date
2022-08-29
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

Overactive bladder OAB

Interventions

Double-blind randomized placebo controlled trial

Sponsors

Fukata Satoshi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All of the following criteria must be met in order to participate in this trial. 1.Patients with overactive bladder over 30 years old 2.Patients with overactive bladder who consented to participate in the study in writing

Exclusion criteria

Exclusion criteria: If any of the following criteria are met, the patient will not be allowed to participate in this trial. 1.Patients with organic disease of the urinary tract 2.Patients with neurogenic overactive bladder 3.Patients with malignant tumors of the urinary sys tem 4.Patients with cognitive dysfunction or psychiatri c disorders that are difficult to conduct research 5.Patients who are allergic to 5-ALA 6.Patients with porphyria 7.Patients with drug hypersensitivity such as iron a llergy 8.Pregnant women or patients who may become p regnant 9.Patients who did not consent to participate in th e study in writing 10.Patients disqualified by a doctor

Design outcomes

Primary

MeasureTime frame
OABSS (Amount of change from baseline in OABSS after 12 weeks)

Secondary

MeasureTime frame
(1) OABSS (Amount of change from baseline in OA BSS after 4 weeks) (2) Change in residual urine volume from baseline (3) Amount of change from baseline in OABq-SF

Contacts

Public ContactSatoshi Fukata

Kochi Medical School Hospital

jm-fukatas@kochi-u.ac.jp+81-88-880-2402

Outcome results

None listed

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