painless laser therapy for overactive bladder

Conditions: Overactive Bladder

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.

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.

Eligibility criteria:
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.

Keywords: overactive bladder laser therapy urinary incontinence urinary urgency