Single blinded randomized control study of low-reactive level laser therapy for overactive bladder

Not Applicable

• Conditions: Overactive bladder

• Registration Number: JPRN-jRCTs032190043
• Lead Sponsor: Tomoyuki Uchiyama

Brief Summary

The purpose was to evaluate the safety and efficacy of low-reactive level laser therapy of the sacral nerve roots in patients with overactive bladder. There was no significant difference in the urination frequency(primary endpoint). There were significant improvements in urinary urgency, bladder capacity, OABSS, and I-PSS. There were no adverse events in the laser group and there were no safety issues.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-20
• Study Completion: 2020-07-03
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Urination frequency is 8 or more times per day on average
2. Falls under any of the following
Urinary incontinence frequency is 1 or more times per day on average
Urinary urgency frequency is 1 or more times per day on average
3. Inadequate or inappropriate effect of behavioral therapy or drug therapy
4. 20 years old and older at IC
5. Outpatient
6. Contraception possible

Exclusion Criteria

1. Severe cardiovascular disease
2. Severe liver disease
3. Severe kidney disease
4. Received intervention treatments in other clinical trials within 3 months
5. Pregnant, or have a plan
6. Tattoo, pigmentation, accessories, implantation equipment at the laser irradiation point
7. Malignant tumor
8. Bleeding tendency
9. Physically weak due to aging, disease, etc
10. Treatment of organic disease is prior
11. Urinary output over 3000ml per day
12. Cognitive impairment, mental illness, etc
13. Judged as ineligible by principle investigator or sub investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in urinary frequency from baseline

Secondary Outcome Measures

Name	Time	Method
1. Bladder diary (urination, urinary incontinence, urine volume, urinary urgency)<br>2. Urodynamic study<br>3. IPSS<br>4. King`s Health Questionnaire<br>5. OABSS