The Effect of Increased Water Intake on the Frequency of the Clinical Recurrent Urinary Tract Infections in Pre-menopausal Women: S-HYDRACYST

Danone

Status: Completed

Conditions: Recurrent Urinary Tract Infection

Treatments: Dietary Supplement: Mineral water; Other: Coaching program; Other: No intervention

Study type: Interventional

Funder types: Industry

Identifiers

NCT02444975

NU369

Details and patient eligibility

About

The purpose of this study is to determine whether increased water intake is effective in preventing episodes of uncomplicated urinary tract infections (UTI) in pre-menopausal women suffering from UTI recurrences.

Full description

This study aims to assess the effect of increased daily water intake on the frequency of clinical, recurrent urinary tract infections (UTI) among low drinking pre-menopausal women suffering from recurrent community-acquired UTI over 12 consecutive months of study product consumption. It is a prospective, single site, open-label, randomised controlled trial in two parallel groups:

• Control group: not changing their fluid intake habits
• Intervention group: provided with mineral water, fluid intake recommendations and regular hydration coaching support

The study population consists in pre-menopausal women diagnosed with recurrent UTIs and having a 'low drinker' profile.

The total number of randomized subjects in this study is estimated at 140. The study will include only women who are low-drinkers (< 1.5 L fluids per day; urinary volume < 1.2 L per day) since they are most likely to have a predisposition to UTIs due to infrequent voiding.

Enrollment: 140 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• At least 3 clinical recurrences of symptomatic UTI in the last 12 months
• Age ≥ 18 years

Exclusion criteria

• Incapacity / non-willingness to consume 1.5 L of drinking water per day on top of their usual consumption
• Women with history of UTI complications (pyelonephritis or other) in the last 12 months
• Subjects with interstitial cystitis
• Subjects with severe or uncontrolled organic disease, likely to interfere with the parameters of the study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

140 participants in 2 patient groups

Increased water intake+coaching program

Experimental group

Description:

Women in the intervention group will be asked to increase their mineral water intake of 1.5L/day

Treatment:

Other: Coaching program

Dietary Supplement: Mineral water

No intervention

Other group

Description:

No intervention

Treatment:

Other: No intervention