Painless Laser Therapy for Overactive Bladder

This study is a double-blind, randomized, sham-controlled, multicenter, clinical trial that
will include enrollment of up to 200 subjects at up to 3 investigational sites.

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.

Inclusion Criteria:

- The subject is female and at least 18 years of age at screening.

- 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 vaginal bleeding.

- 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.