Painless Laser Therapy for Overactive Bladder

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Overactive Bladder

In brief

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.

Key facts

Study ID

NCT01569061

Run by

Zipper Urogynecology Associates

People needed

200

Starts

2012-02-01

Expected to finish

2013-12-01

Last updated by the study team

2012-04-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• Zipper Urogynecology Associates — Melbourne, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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