Painless Laser Therapy for Overactive Bladder

A Double-blind, Randomized, Sham-controlled, Multicenter Clinical Trial to Assess the Effectiveness of Therapeutic Class IV Laser LCT-1000TM Treatment for Overactive Bladder Syndrome.

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.

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.