Recruiting

Painless Laser Therapy

Sponsor:

Zipper Urogynecology Associates

Code:

NCT01569061

Conditions

Overactive Bladder

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

LCT-1000TM (Manufacturer: LiteCure)

LCT-1000TM (Manufacturer: LiteCure)

Study Details

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.

Conditions

Overactive Bladder

Study ID

NCT01569061

Start date

Feb, 2012

Status verified date

Mar, 2012

Completion date

Dec, 2013

Anticipated

Primary completion date

Aug, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active Laser Group (ALG)

sham comparator: Sham Laser Group (SLG)

Interventions

LCT-1000TM (Manufacturer: LiteCure)

low level laser therapy (LLLT)

LCT-1000TM (Manufacturer: LiteCure)

low level laser therapy (LLLT) sham treatment

Primary outcome 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. [ Time Frame: Visits 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13 (over approximately 7 weeks) ]
  • 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. [ Time Frame: Visits 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13 (over approximately 8 weeks) ]

Central Contacts and Locations

Central contacts

Ralph Zipper, MD

321-674-2114drzipper@zipperurogyn.com

James Raders, MD

321-674-2114jraders@zipperurogyn.com

Locations

Zipper Urogynecology Associates

Recruiting

Melbourne, Florida, United States, 32901

Contacts

Ralph Zipper, MD

321-674-2114drzipper@zipperurogyn.com

James Raders, MD

321-674-2114jraders@zipperurogyn.com

Principal Investigator:

Ralph Zipper, MD

More Information

Sponsor

Zipper Urogynecology Associates

Last update posted

Apr 2, 2012

Last verified

Mar, 2012

Keywords

  • overactive bladder
  • laser therapy
  • urinary incontinence
  • urinary urgency

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Zipper Urogynecology Associates on 2012-04-02.