Comparative Effect of 3 Different Cranberry Extracts on Cystitis Related Urinary Comfort in Women

Completed

• Conditions: Recurrent Cystitis
• Interventions: Dietary Supplement: Y; Dietary Supplement: Z; Dietary Supplement: X

• Registration Number: NCT04962971
• Lead Sponsor: CEN Biotech

Brief Summary

Urinary discomfort includes a set of signs such as an urgent need to urinate, high frequency of urination per day, discomfort / difficulty or burning sensation when urinating, smelly urine. This urinary discomfort represents in women 2 to 5% of the reasons for consultation (Berg, 1991) and can have various etiologies but the bacterial origin is the most frequent. Cranberries are traditionally used for urinary comfort and the prevention of urinary disorders with bacterial origin.

The study objective is to collect in real life efficacy and tolerance data from the consumption of 3 cranberry extracts in order to highlight the qualitative and quantitative characteristics of these extracts which are directly involved in the improvement of urinary discomfort or situation of recurrent cystitis symptomatic episodes in women.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2021-06-17
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-05
• Study First Posted: 2021-07-15
• Primary Completion: 2021-10-01
• Study Completion: 2022-02-01
• Last Update Submitted: 2022-04-11
• Last Update Posted: 2022-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 216

Inclusion Criteria

• having had at least 3 symptomatic episodes of cystitis (including 1 urinary tract infection confirmed by a doctor) during the last 12 months
• whose episode had a significant impact on quality of life / urinary discomfort (ACSS Dimension QoL ≥ 2)
• had a smartphone compatible with Nurstrial smartphone application (e-CRF)

Exclusion Criteria

• to be a pregnant or breastfeeding woman or planning to be pregnant within 6 months,
• currently taking any other supplementation for urinary comfort or having taken any other cranberry-based food supplement in the past 3 months,
• to be under antibiotic treatment or during the last 7 days preceding inclusion,
• have urinary discomfort with a severe impact on quality of life (ACSS QoL> 7) during the last 24 hours prior to inclusion,
• have an allergy known to plants of the cranberry family or to one of the components of the products.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cranberry extract Y	Y	404 mg per Day
Cranberry extract Z	Z	2090 mg per Day
Cranberry extract X	X	373 mg per Day

Primary Outcome Measures

Name	Time	Method
Change of the Urinary comfort	on weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24	Visual Analogic score
Change of the Quality of life related to urinary discomfort	at weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24	ACCS Quality of life score

Secondary Outcome Measures

Name	Time	Method
Intensity of urinary disconfort	Every day during each urinary symptoms episod (Week 0 to Week 24)	Global ACCS score
Patient Global Impression of Improvement	Week 4,Week 12,Week 24	PGI-I scale related to Urinary discomfort
Duration without antibiotic treatment	on Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24	Collection of the intake and the duration of the antibiotic treatment, if applicable
Observance of the supplementation	on Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24	Total products minus remaining products
Tolerance of the supplementation	Week 4,Week 12,Week 24	Adverse events assessment
Evolution of the impact of urinary discomfort on psychosocial life	Week 0,Week 4,Week 12,Week 24	Likert 5 points scales
Satisfaction of the supplementation	Week 4,Week 12,Week 24	Likert 5 points scales

Trial Locations

Locations (1)

CEN Nutriment; 🇫🇷 Dijon, Burgundy, France