Clinical trial NCT04747041: Evaluation of a Phyto Aromatherapy Treatment in the Management of Recurrent Cystitis
Official title: Evaluation of a Phyto Aromatherapy Treatment in the Management of Recurrent Cystitis Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystitis Recurrent
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Half of the women have a once-in-a-lifetime episode of cystitis. Recurrence occurs in about 20% to 30% of patients, and half of these patients will have more than 4 episodes per year, defining recurrent cystitis.

The clinical assessment sometimes brings to light favourable factors; variables in pre- or post-menopause; but in the majority of cases, no explanatory cause can solve the problem and some authors refer to resignation as a classic reaction to this problem.

several countries have already opted for alternative treatments (Nonsteroidal anti-inflammatory drugs, phytotherapy, diuresis treatment), especially since the pressure of antibiotic selection is at the root of the dramatic spread of bacterial resistances.

There is a growing interest in the potential of complementary medicine to assist in this care. Products based on cranberries, for example, have been particularly studied and a 2012 Cochrane review concluded that there is a benefit with an estimated risk reduction of between 10 and 20%. Another "alternative" approach is the use of Chinese medicinal herbs. These herbs have been used for more than 2000 years.

The implementation of phyto-aromatherapy treatment implies a global management of patients with recurrent cystitis. Initially, it involves a curative phase as soon as the first symptoms of the attack appear, thanks to a mixture of antibacterial essential oils. In a second phase, it integrates a preventive phase over several months thanks to an association of medicinal plants whose effects in this field have been proven in vitro and in vivo, allowing to rebalance a "terrain" associating anxiety, hypersensitivity to pain, a terrain willingly associated with the irritable bowel syndrome in these patients. While having few side effects, the plants will act, in the long term, at different levels: directly on the cause of the disease thanks to their antiseptic, antiadhesive and diuretic activities, but also by reducing the symptoms thanks to their anti-inflammatory, analgesic, antispasmodic and anxiolytic activities.

Investigators hypothesize that patients with recurrent cystitis can be improved by a two-phase, multi-plant, phyto-aromatherapy treatment combining several plants: the treatment of attacks, by aromatherapy, and a prophylactic treatment, by phytotherapy. In the absence of any such studies published in the literature, investigators propose a non-randomised prospective monocentric interventional pilot study on 15 patients with proof of concept and feasibility.


Eligibility criteria: Inclusion Criteria:

* Women aged 18 or older.
* Affiliated to social security.
* Presenting recurrent cystitis defined by a frequency of at least 4 episodes per year.
* For women of childbearing age: effective contraception followed for at least 3 months prior to the start of the study and agreeing to keep it throughout the study period
* Available to consult a phyto-aromatherapy pharmacist for an initial consultation and then every 3 months (M3, 6,9, 12) and then at 18 months.
* Having been previously explored according to good practice and informed
* Having signed the informed consent

Exclusion Criteria:

* Pregnant or breastfeeding women
* Severe visceral deficiencies in the previous year.
* Individualised psychiatric pathology.
* Other progressive infectious pathologies requiring antibiotic treatment.
* Taking anticoagulants.
* Concomitant intake of non-drug treatments.

Primary outcomes:
measure: adherence to phyto-aromatherapy treatment
timeFrame: 12th month
Secondary outcomes:
measure: Antibiotic treatments
timeFrame: 12 months
measure: Number of cystitis
timeFrame: 12 months
measure: Patients' overall satisfaction
timeFrame: 12 months
measure: Recording adverse events
timeFrame: 18 months
measure: The benefit persisting at 6 months after stopping treatment with phyto-aromatherapy
timeFrame: During 6 months after stopping treatment (patient stop treatment at Month12 so between the 12th and 18th month)
measure: Evaluation of the evolution of bacterial resistance on phenotypes isolated from the cytobacteriological examination of urine
timeFrame: From date of inclusion until the date of documented episode of cystitis, assessed up to 18 months
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpital Archet
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Veronique MONDAIN
role: PRINCIPAL_INVESTIGATOR
References: