Evaluation of the Effect of Dried Cranberry Powder in Women With Dry OAB

Completed · Phase 1 · Has a placebo group

Conditions studied: Overactive Bladder

In brief

A randomized, double-blind, placebo controlled study to evaluate the efficacy of dried cranberry at 500 mg daily in women with overactive bladder for 6-months.

Key facts

Study ID

NCT03017170

Run by

Weill Medical College of Cornell University

People needed

77

Starts

2016-04-01

Expected to finish

2018-07-01

Last updated by the study team

2018-09-17

Who can join

Age: 18 and older, up to 100. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Ambulatory female subject ≥ 18 years of age and able to use the toilet without difficulty
• OAB symptoms for ≥ 6 months
• Frequency of micturition ≥ 8 times per 24 hr and ≥ 3 episodes of urgency (grade 3 or 4) without incontinence during the 3-day micturition diary period at baseline
• Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study
• Speak English and are able to understand the nature of the study
• Able to give signed written informed consent
• Signed informed consent form

You may not qualify if…

• Significant bladder outflow obstruction
• Urinary Incontinence (defined as greater than 3 incontinence episodes in the month prior to screening)
• Catheterization (indwelling catheter)
• Diabetic neuropathy and unstable diabetes mellitus
• Urinary tract infection (UTI) at screening and recurrent UTI defined as ≥ 3 UTIs in the previous 12 months
• Urethral diverticulum
• Neurogenic bladder
• Chronic urologic inflammatory condition (Interstitial cystitis, urethral syndrome, painful bladder syndrome)
• Bladder stones
• History of carcinoma of the urinary tract
• Lower urinary tract surgery in the last 6 months
• Abnormal baseline urinalysis
• Previous pelvic radiation therapy or previous, current malignant disease of the pelvic organs or has received intravesical injection or electrostimluation in the past 12 months
• Planning to undergo urologic procedures for which mucosal bleeding is anticipated
• Drug or Nondrug treatments of OAB (in the previous 56 days), Concomitant medications that affect detrusor activity
• Cerebrovascular diseases
• Neurological impairment or psychiatric disorder preventing appropriate understanding of consent and ability to comply with site personnel instructions
• History of drug or alcohol abuse within the last 12 months.
• Has participated in a study involving the administration of an investigational agent within the past 30 days, or within six half-lives of the prior investigational agent, whichever is longer.
• Subjects on Warfarin
• Females of childbearing potential who are pregnant or planning to become pregnant during the course of the study or breast-feeding
• Subjects with history of kidneys stones
• Treatable condition that could cause urinary incontinence or urgency
• Planning to undergo urologic procedures for which mucosal bleeding is anticipated
• Previous allergic conditions to cranberry products

Where it is running

• Weill Cornell Medical College — New York, New York, United States

Full record on ClinicalTrials.gov

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