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Painless Laser Therapy for Overactive Bladder (PLTOAB)

Primary Purpose

Overactive Bladder

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

LCT-1000TM (Manufacturer: LiteCure)

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring overactive bladder, laser therapy, urinary incontinence, urinary urgency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Zipper Urogynecology AssociatesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active Laser Group (ALG)

Sham Laser Group (SLG)

Arm Description

Outcomes

Primary Outcome Measures

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.

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.

Patients will undergo 3 LLLT procedures per week for 3 weeks, for a total of 9 LLLT procedures.

Secondary Outcome Measures

Full Information

NCT ID

NCT01569061

First Posted

March 26, 2012

Last Updated

March 29, 2012

Sponsor

Zipper Urogynecology Associates

1. Study Identification

Unique Protocol Identification Number

NCT01569061

Brief Title

Painless Laser Therapy for Overactive Bladder

Acronym

PLTOAB

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

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Unknown status

Study Start Date

February 2012 (undefined)

Primary Completion Date

August 2013 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zipper Urogynecology Associates

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overactive Bladder

Keywords

overactive bladder, laser therapy, urinary incontinence, urinary urgency

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active Laser Group (ALG)

Arm Type

Active Comparator

Arm Title

Sham Laser Group (SLG)

Arm Type

Sham Comparator

Intervention Type

Device

Intervention Name(s)

LCT-1000TM (Manufacturer: LiteCure)

Intervention Description

low level laser therapy (LLLT)

Intervention Type

Device

Intervention Name(s)

LCT-1000TM (Manufacturer: LiteCure)

Intervention Description

low level laser therapy (LLLT) sham treatment

Primary Outcome Measure Information:

Title

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.

Description

Patients will undergo 3 LLLT procedures per week for 3 weeks, for a total of 9 LLLT procedures.

Time Frame

Visits 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13 (over approximately 7 weeks)

Title

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.

Description

Patients will undergo 3 LLLT procedures per week for 3 weeks, for a total of 9 LLLT procedures.

Time Frame

Visits 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13 (over approximately 8 weeks)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ralph Zipper, MD

Phone

321-674-2114

drzipper@zipperurogyn.com

First Name & Middle Initial & Last Name or Official Title & Degree

James Raders, MD

Phone

321-674-2114

jraders@zipperurogyn.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ralph Zipper, MD

Organizational Affiliation

Zipper Urogynecology Associates

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zipper Urogynecology Associates

City

Melbourne

State/Province

Florida

ZIP/Postal Code

32901

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ralph Zipper, MD

Phone

321-674-2114

drzipper@zipperurogyn.com

First Name & Middle Initial & Last Name & Degree

James Raders, MD

Phone

321-674-2114

jraders@zipperurogyn.com

First Name & Middle Initial & Last Name & Degree

Ralph Zipper, MD

12. IPD Sharing Statement

Links:

URL

http://www.zipperurogyn.com/

Description

Zipper Urogynecology Associates

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Painless Laser Therapy for Overactive Bladder

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