Evaluation of a Phyto Aromatherapy Treatment in the Management of Recurrent Cystitis

NCT04747041 | Active Not Recruiting

• 1 other identifier: 17-AOIP-02
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystitis Recurrent

Outcome Measures

Primary Outcomes (1)

• adherence to phyto-aromatherapy treatment

  The scale called "treatment compliance" ranges from 1 to 10. A score of 1 means not at all observant and 10 means very observant.

  12th month

Secondary Outcomes (6)

• Antibiotic treatments

  12 months

• Number of cystitis

  12 months

• Patients' overall satisfaction

  12 months

• Recording adverse events

  18 months

• The benefit persisting at 6 months after stopping treatment with phyto-aromatherapy

  During 6 months after stopping treatment (patient stop treatment at Month12 so between the 12th and 18th month)

Study Arms (1)

Alternating each month for 1 year between Phytocyst herbal tea and Cyscontrol

EXPERIMENTAL

Alternating each month (From Day1 to DAY15) for 1 year between Phytocyst herbal tea and Cyscontrol = Preventive Treatment In case of episode of cystitis : AROMAFEMINA, Capsules for the comfort of the urinary tract Oleocaps 2 : 2 capsules before meals, 3 times a day for 5 consecutive days.

Combination Product: CYSCONTROL/PHYTOCYST Herbal tea

Interventions

CYSCONTROL/PHYTOCYST Herbal tea COMBINATION_PRODUCT

Alternating every month from Day1 to Day15 cyscontrol and phytocyst herbal tea to prevent episode of cystitis

Alternating each month for 1 year between Phytocyst herbal tea and Cyscontrol

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Hôpital Archet

Nice, 06202, France

Location

Study Officials

• Veronique MONDAIN

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 10, 2021
• Study Start: May 18, 2021
• Primary Completion: June 20, 2023
• Study Completion: January 23, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

FR (1)