The Effect of Urox™ in the Treatment of Overactive Bladder and Urinary Incontinence

NCT02396160 | Completed Results DMC

• 1 other identifier: SG-04
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to assess the efficacy of a specialized herbal formula, Urox, versus control over 8 weeks, in a double blind, placebo controlled trial. 150 participants are being recruited, randomized and administered treatment or placebo for the period of 8 weeks after initial eligibility screening. Outcome measures include previously validated tools such as the 3 day symptom diary measuring self-recorded day frequency, nocturia, urgency and incontinence episodes. Quality of life improvements are being measured using the Incontinence Impact Questionnaire, Urinary Distress Inventory and the short version of the OverActive Bladder survey.

Conditions

Overactive Bladder; Urinary Incontinence; Urinary Frequency or Urgency Adverse Event; Nocturia

Keywords

overactive bladder; urinary incontinence; nocturia; urinary frequency

Outcome Measures

Primary Outcomes (2)

• Day Urinary Frequency

  Day urinary frequency as defined as the number of voluntary diurnal micturitions per day, recorded in a validated urinary diary

  8 weeks

• Nocturia Frequency

  Night time urinary frequency as defined as the number of voluntary nocturnal micturition's per day recorded in a validated urinary diary

  8 weeks

Secondary Outcomes (3)

• Urinary Urgency Frequency

  8 weeks

• Urge Incontinence Frequency

  8 weeks

• Stress Incontinence Frequency

  8 weeks

Study Arms (2)

Treatment

ACTIVE COMPARATOR

2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root

Dietary Supplement: Urox

Placebo

PLACEBO COMPARATOR

identical placebo vegetarian capsule containing color-matched cellulose

Other: Placebo

Interventions

Urox DIETARY_SUPPLEMENT

Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs

Treatment

Placebo OTHER

Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment

Placebo

Eligibility Criteria

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

You may not qualify if:

• Recent surgery particularly hysterectomy or prolapse repair (within the last 12 months)
• Recently undergone childbirth (within the last 12 months), or currently pregnant.
• Use of any natural therapies for bladder symptoms in the last month.
• Concomitant health conditions such as uncontrolled diabetes mellitus, heart disease, pancreatic, hepatic or renal disease, recurrent urinary tract infections, and chronic inflammatory conditions, which may otherwise affect outcomes.
• Currently being treated for mental health issues or psychiatric disturbances.
• Any individuals who are presently taking prescribed medication for incontinence or OAB.

Sponsors & Collaborators

• The University of Queensland: lead
• University of Tasmania: collaborator
• Seipel Group Pty Ltd: collaborator
• Endeavour College of Natural Health: collaborator

Related Publications (1)

• Schoendorfer N, Sharp N, Seipel T, Schauss AG, Ahuja KDK. Urox containing concentrated extracts of Crataeva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root, in the treatment of symptoms of overactive bladder and urinary incontinence: a phase 2, randomised, double-blind placebo controlled trial. BMC Complement Altern Med. 2018 Jan 31;18(1):42. doi: 10.1186/s12906-018-2101-4.

  PMID: 29385990 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence; Nocturia

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

Limitations and Caveats

Limitations of this study include the relatively short duration and lack of long-term follow up. As a phase 2 clinical trial, there was no active comparator and a smaller sample size was also utilized.

Results Point of Contact

• Title: Dr Niikee Schoendorfer
• Organization: University of Queensland

n.schoendorfer@uq.edu.au

0413122076

Study Officials

• Niikee Schoendorfer, PhD

  The University of Queensland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: March 24, 2015
• Study Start: August 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: May 1, 2015
• Last Updated: May 5, 2016
• Results First Posted: May 5, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share