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Improvement effect and safety of overactive bladder symptoms

Phase 2
Recruiting
Conditions
OAB
D053201
Overactive bladder
Registration Number
JPRN-jRCTs061220050
Lead Sponsor
Fukata Satoshi
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
100
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
OABSS (Amount of change from baseline in OABSS<br>after 12 weeks)
Secondary Outcome Measures
NameTimeMethod
(1) OABSS (Amount of change from baseline in OA<br>BSS after 4 weeks)<br>(2) Change in residual urine volume from baseline<br>(3) Amount of change from baseline in OABq-SF
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