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

• Status: Completed
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborator: Naturex-Dbs

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Gastrointestinal obstruction or retention or fecal impaction

• Failure to complete baseline 3-day diary

• Subjects unable to swallow the capsule of the intervention

• Subjects with gross hematuria

• Judged by the investigator to be unsuitable for enrollment in this study for any reason

• Allergy or sensitivity to aspirin

• Aspirin dose > 81 mg

• Subjects taking other prescription anti-platelet agents (e.g. clopidogrel, ticlopidine, prasugrel, and ticagrelor)

• Subject has moderate to severe hepatic impairment (Child-Pugh class B or C)

• Subject has severe renal impairment defined as eGFR<30 mL/min/1.73 m2)