Clinical trial NCT01569061: Painless Laser Therapy for Overactive Bladder
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overactive Bladder
Keywords: overactive bladder
laser therapy
urinary incontinence
urinary urgency
Lead sponsor: Zipper Urogynecology Associates
Sponsor class: OTHER
First posted: 2012-04-02
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Primary outcomes:
measure: 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.
timeFrame: Visits 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13 (over approximately 7 weeks)
measure: 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.
timeFrame: Visits 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13 (over approximately 8 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: United States
facility: Zipper Urogynecology Associates
state: Florida
Study officials:
affiliation: Zipper Urogynecology Associates
name: Ralph Zipper, MD
role: PRINCIPAL_INVESTIGATOR
References: