Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2025-12-30 @ 1:32 PM
Study NCT ID:
NCT01569061
Status:
UNKNOWN
Last Update Posted:
2012-04-02
First Post:
2012-03-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Painless Laser Therapy for Overactive Bladder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014555', 'term': 'Urination Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-29', 'studyFirstSubmitDate': '2012-03-26', 'studyFirstSubmitQcDate': '2012-03-29', 'lastUpdatePostDateStruct': {'date': '2012-04-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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)', 'description': 'Patients will undergo 3 LLLT procedures per week for 3 weeks, for a total of 9 LLLT procedures.'}, {'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)', 'description': 'Patients will undergo 3 LLLT procedures per week for 3 weeks, for a total of 9 LLLT procedures.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['overactive bladder', 'laser therapy', 'urinary incontinence', 'urinary urgency'], 'conditions': ['Overactive Bladder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.zipperurogyn.com/', 'label': 'Zipper Urogynecology Associates'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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).\n\nBoth 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject is female and at least 18 years of age at screening.\n* A score of \\> 4 on the OAB-q short form for urgency.\n* The subject has an average urinary frequency of \\> 10 voids per day.\n* Self-reported bladder symptoms for \\> 3 months.\n* Self-reported failed conservative care.\n* The subject has discontinued all antimuscarinics for at least 2 weeks prior to screening.\n* The subject is ambulatory and able to use the toilet independently and without difficulty.\n* Negative pregnancy test in subjects of childbearing potential.\n* 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.\n* Subject Informed Consent obtained in writing in compliance with local regulations prior to enrollment into this study.\n* The subject (and caregiver, if applicable) is willing to participate in this study for at least 7 weeks.\n* The subject is otherwise in general good health with no other major medical conditions.\n\nExclusion Criteria:\n\n* The subject has vaginal bleeding.\n* The subject has urinary or gastric retention or a neurogenic bladder.\n* The subject is not capable of completing study questionnaires or undergoing portions of the study.\n* The subject has been sexually assaulted.\n* The subject has an alcohol or drug addiction.\n* The subject has used isotretinoin (Accutane) within 6 months prior to study enrollment.\n* The subject has cancer.\n* The subject has used Botox® in the bladder or pelvic floor muscles within 12 months prior to study enrollment.\n* The subject currently has a urinary tract infection or vaginal infection.\n* The subject is using Interstim® or Bion®.\n* Current use of TENS in pelvic region, back or legs.\n* 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.\n* Any use of light-activated drugs (photodynamic therapy) or heat sensitive medications within 30 days of first treatment.\n* 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.\n* The subject is otherwise determined, based on the opinion of the Investigator, to be an unsuitable candidate for enrollment in this study.'}, 'identificationModule': {'nctId': 'NCT01569061', 'acronym': 'PLTOAB', 'briefTitle': 'Painless Laser Therapy for Overactive Bladder', 'organization': {'class': 'OTHER', 'fullName': 'Zipper Urogynecology Associates'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': '11-179'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Laser Group (ALG)', 'interventionNames': ['Device: LCT-1000TM (Manufacturer: LiteCure)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Laser Group (SLG)', 'interventionNames': ['Device: LCT-1000TM (Manufacturer: LiteCure)']}], 'interventions': [{'name': 'LCT-1000TM (Manufacturer: LiteCure)', 'type': 'DEVICE', 'description': 'low level laser therapy (LLLT)', 'armGroupLabels': ['Active Laser Group (ALG)']}, {'name': 'LCT-1000TM (Manufacturer: LiteCure)', 'type': 'DEVICE', 'description': 'low level laser therapy (LLLT) sham treatment', 'armGroupLabels': ['Sham Laser Group (SLG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32901', 'city': 'Melbourne', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ralph Zipper, MD', 'role': 'CONTACT', 'email': 'drzipper@zipperurogyn.com', 'phone': '321-674-2114'}, {'name': 'James Raders, MD', 'role': 'CONTACT', 'email': 'jraders@zipperurogyn.com', 'phone': '321-674-2114'}, {'name': 'Ralph Zipper, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zipper Urogynecology Associates', 'geoPoint': {'lat': 28.08363, 'lon': -80.60811}}], 'centralContacts': [{'name': 'Ralph Zipper, MD', 'role': 'CONTACT', 'email': 'drzipper@zipperurogyn.com', 'phone': '321-674-2114'}, {'name': 'James Raders, MD', 'role': 'CONTACT', 'email': 'jraders@zipperurogyn.com', 'phone': '321-674-2114'}], 'overallOfficials': [{'name': 'Ralph Zipper, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zipper Urogynecology Associates'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zipper Urogynecology Associates', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ralph Zipper, MD', 'investigatorAffiliation': 'Zipper Urogynecology Associates'}}}}