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Painless Laser Therapy for Overactive Bladder (PLTOAB Trial)
N/A
Waitlist Available
Led By Ralph Zipper, MD
Research Sponsored by Zipper Urogynecology Associates
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visits 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13 (over approximately 8 weeks)
Summary
The primary objective of this study is to determine the effectiveness of transvaginally-delivered low level laser therapy (LLLT) versus Sham in the treatment of overactive bladder symptoms in women. The secondary objective is to determine the effect of transvaginally-delivered LLLT vs. sham on the quality of life.
Eligible Conditions
- Overactive Bladder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ visits 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13 (over approximately 8 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visits 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13 (over approximately 8 weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The primary efficacy endpoint will be the improvement of OAB symptoms and general quality of life due to the effect of LLLT treatment on OAB through week 7.
The primary safety endpoint will evaluate the SLG and ALG treatment groups for differences in reported side effects and adeverse events throughout the trial, including LLLT treatment and follow-up.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active Laser Group (ALG)Active Control1 Intervention
Group II: Sham Laser Group (SLG)Placebo Group1 Intervention
Find a Location
Who is running the clinical trial?
Zipper Urogynecology AssociatesLead Sponsor
Ralph Zipper, MDPrincipal InvestigatorZipper Urogynecology Associates