Overactive BladderPLTOABNCT01569061
Painless Laser Therapy for Overactive Bladder
A study testing LCT-1000TM (Manufacturer: LiteCure) in people with Overactive Bladder, run by Zipper Urogynecology Associates at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- LCT-1000TM (Manufacturer: LiteCure)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Zipper Urogynecology Associates
Melbourne, Florida, 32901
Ralph Zipper, MD, 321-674-2114, drzipper@zipperurogyn.com
James Raders, MD, 321-674-2114, jraders@zipperurogyn.com
About this study
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.
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.
Read the 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.
- Conditions
- Overactive Bladder
- Being tested
- LCT-1000TM (Manufacturer: LiteCure)
- Keywords
- overactive bladder, laser therapy, urinary incontinence, urinary urgency
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCT-1000TM (Manufacturer: LiteCure)Device
low level laser therapy (LLLT)
LCT-1000TM (Manufacturer: LiteCure)Device
low level laser therapy (LLLT) sham treatment
| Study group | Role | What they receive |
|---|---|---|
| Active Laser Group (ALG) | Active comparator | Not described Receives: Device: LCT-1000TM (Manufacturer: LiteCure) |
| Sham Laser Group (SLG) | Sham comparator | Not described Receives: Device: LCT-1000TM (Manufacturer: LiteCure) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Patients will undergo 3 LLLT procedures per week for 3 weeks, for a total of 9 LLLT procedures.
Measured: Visits 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13 (over approximately 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startFeb 2012
- Primary completionAug 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zipper Urogynecology Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ralph Zipper, MD, Zipper Urogynecology Associates
- Investigators
- Ralph Zipper, MD, Principal investigator, Zipper Urogynecology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569061
- Sponsor's protocol ID
- 11-179
- Acronym
- PLTOAB
- Status last verified
- Mar 2012
- First submitted
- 26 Mar 2012
- Last updated
- 2 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01569061
- Acronym / sponsor ID
- PLTOAB / 11-179
- Conditions
- Overactive Bladder
- Keywords
- overactive bladder, laser therapy, urinary incontinence, urinary urgency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zipper Urogynecology AssociatesUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 2 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Laser Group (ALG) | Active comparator | Device: LCT-1000TM (Manufacturer: LiteCure) |
| Sham Laser Group (SLG) | Sham comparator | Device: LCT-1000TM (Manufacturer: LiteCure) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LCT-1000TM (Manufacturer: LiteCure)low level laser therapy (LLLT) | Device | Active Laser Group (ALG) |
| LCT-1000TM (Manufacturer: LiteCure)low level laser therapy (LLLT) sham treatment | Device | Sham Laser Group (SLG) |
Primary outcome
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)
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.
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2012.
- Zipper Urogynecology AssociatesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph Zipper, MD principal investigator
Zipper Urogynecology Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LCT-1000TM (Manufacturer: LiteCure) in people with Overactive Bladder, run by Zipper Urogynecology Associates at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ralph Zipper, MD (321-674-2114, drzipper@zipperurogyn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2012.