Improvement effect and safety of overactive bladder symptoms

JRCT ID: jRCTs061220050

Registered date:29/08/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Overactive bladder
• Date of first enrollment: 29/08/2022
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Double-blind randomized placebo controlled trial

Outcome(s)

Primary Outcome

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

Secondary Outcome

(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

Key inclusion & exclusion criteria

• Age minimum: >= 30age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Fukata Satoshi