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

NCT03017170 | Completed Phase 1

• 1 other identifier: 1506016303
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• Mean change in number of micturitions per day from baseline until end of treatment

  6 Months

Secondary Outcomes (6)

• Change in number of urgency and frequency episodes per 24 hours from baseline until end of treatment

  6 Months

• Change in number of micturitions occuring during the night from baseline until end of treatment

  6 Months

• Change in overactive bladder questionnaire short form (OABQ-SF) score

  6 Months

• Change in patient perception of bladder condition (PPBC) score

  6 Months

• Change in Sexual Quality of Life-Female (SQOL-F) score

  6 Months

Study Arms (2)

Cranberry

EXPERIMENTAL

500mg Dried Cranberry

Drug: Dried Cranberry

Placebo Oral Capsule

PLACEBO COMPARATOR

Color Matching Placebo

Drug: Placebo Oral Capsule

Interventions

Dried Cranberry DRUG

Dried cranberry powder is not an "extract" of cranberries, but a "full spectrum" ingredient. It is comprised of a proprietary ratio of dried cranberry fruit, cranberry pomace, and cranberry seeds, each of which is a recognized food and/or dietary ingredient. One 500 mg capsule of dried cranberry powder consists of approximately 25 grams of cranberry fruit.

Also known as: Cranberry

Cranberry

Placebo Oral Capsule DRUG

Colored Maltodextrin: Proprietary mixture of: maltodextrin and food grade colors

Also known as: Placebo

Placebo Oral Capsule

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Naturex-Dbs: collaborator

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

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

Study Officials

• Bilal Chughtai, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2016
• First Posted: January 11, 2017
• Study Start: April 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: September 17, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)