Painless Laser Therapy for Overactive Bladder

NCT01569061 | Unknown

• 1 other identifier: 11-179
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

overactive bladder; laser therapy; urinary incontinence; urinary urgency

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Study Arms (2)

Active Laser Group (ALG)

ACTIVE COMPARATOR

Device: LCT-1000TM (Manufacturer: LiteCure)

Sham Laser Group (SLG)

SHAM COMPARATOR

Device: LCT-1000TM (Manufacturer: LiteCure)

Interventions

LCT-1000TM (Manufacturer: LiteCure) DEVICE

low level laser therapy (LLLT)

Active Laser Group (ALG)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zipper Urogynecology Associates: lead

Study Sites (1)

Zipper Urogynecology Associates

Melbourne, Florida, 32901, United States

RECRUITING

Related Links

• Zipper Urogynecology Associates

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders

Study Officials

• Ralph Zipper, MD

  Zipper Urogynecology Associates

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ralph Zipper, MD

CONTACT

321-674-2114; drzipper@zipperurogyn.com

James Raders, MD

CONTACT

321-674-2114; jraders@zipperurogyn.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2012
• First Posted: April 2, 2012
• Study Start: February 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 2, 2012

Record last verified: 2012-03

Locations

US (1)