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.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: Visits 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13 (over approximately 7 weeks)
Patients will undergo 3 LLLT procedures per week for 3 weeks, for a total of 9 LLLT procedures.
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.
时间窗: Visits 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13 (over approximately 8 weeks)
Patients will undergo 3 LLLT procedures per week for 3 weeks, for a total of 9 LLLT procedures.
次要结局
未报告次要终点
研究者
Ralph Zipper, MD
Principal Investigator
Zipper Urogynecology Associates