Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2012-02-29
2013-12-31
Brief Summary
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Detailed Description
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The study population will be randomized at a 1:1 ratio into two groups: Sham Laser Group (SLG) and Active Laser Group (ALG). The Sham Laser Group will receive a sham LLLT procedure (no laser energy) and the Active Laser Group will receive an active LLLT procedure (laser energy).
Both groups will undergo 3 LLLT procedures per week for 3 weeks, for a total of 9 LLLT procedures. Whether the procedure will be a sham procedure (placebo) or an active LLLT application will be determined by randomization which will assign subjects to be treated with an LCT-1000TM labeled either Laser A or Laser B. The only difference between Laser A and Laser B is that one does not emit laser energy; therefore, both subjects and site research personnel will be blinded as to whether laser energy is actually applied to the subject.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active Laser Group (ALG)
LCT-1000TM (Manufacturer: LiteCure)
low level laser therapy (LLLT)
Sham Laser Group (SLG)
LCT-1000TM (Manufacturer: LiteCure)
low level laser therapy (LLLT) sham treatment
Interventions
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LCT-1000TM (Manufacturer: LiteCure)
low level laser therapy (LLLT)
LCT-1000TM (Manufacturer: LiteCure)
low level laser therapy (LLLT) sham treatment
Eligibility Criteria
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Inclusion Criteria
* A score of \> 4 on the OAB-q short form for urgency.
* The subject has an average urinary frequency of \> 10 voids per day.
* Self-reported bladder symptoms for \> 3 months.
* Self-reported failed conservative care.
* The subject has discontinued all antimuscarinics for at least 2 weeks prior to screening.
* The subject is ambulatory and able to use the toilet independently and without difficulty.
* Negative pregnancy test in subjects of childbearing potential.
* Subject attests in writing that she has not had unprotected intercourse within 3 weeks prior to study enrollment and agrees to have no intercourse until treatments conclude.
* Subject Informed Consent obtained in writing in compliance with local regulations prior to enrollment into this study.
* The subject (and caregiver, if applicable) is willing to participate in this study for at least 7 weeks.
* The subject is otherwise in general good health with no other major medical conditions.
Exclusion Criteria
* The subject has urinary or gastric retention or a neurogenic bladder.
* The subject is not capable of completing study questionnaires or undergoing portions of the study.
* The subject has been sexually assaulted.
* The subject has an alcohol or drug addiction.
* The subject has used isotretinoin (Accutane) within 6 months prior to study enrollment.
* The subject has cancer.
* The subject has used Botox® in the bladder or pelvic floor muscles within 12 months prior to study enrollment.
* The subject currently has a urinary tract infection or vaginal infection.
* The subject is using Interstim® or Bion®.
* Current use of TENS in pelvic region, back or legs.
* The subject is pregnant or lactating, or is of childbearing potential unless she is surgically sterile or she and/or her partner are using a medically acceptable method of birth control.
* Any use of light-activated drugs (photodynamic therapy) or heat sensitive medications within 30 days of first treatment.
* The subject has used an investigational drug/device therapy or participated in any clinical investigation involving or impacting gynecologic, urinary, or renal function within 4 weeks prior to study enrollment.
* The subject is otherwise determined, based on the opinion of the Investigator, to be an unsuitable candidate for enrollment in this study.
18 Years
FEMALE
No
Sponsors
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Zipper Urogynecology Associates
OTHER
Responsible Party
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Ralph Zipper, MD
Principal Investigator
Principal Investigators
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Ralph Zipper, MD
Role: PRINCIPAL_INVESTIGATOR
Zipper Urogynecology Associates
Locations
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Zipper Urogynecology Associates
Melbourne, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Zipper Urogynecology Associates
Other Identifiers
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11-179
Identifier Type: -
Identifier Source: org_study_id
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