Cystitis RecurrentCYSTALTERNANCT04747041
Evaluation of a Phyto Aromatherapy Treatment in the Management of Recurrent Cystitis
A study of Cystitis Recurrent, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cystitis Recurrent
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 18 May 2021to 23 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Phyto Aromatherapy Treatment in the Management of Recurrent Cystitis Preliminary Study
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.
Read more
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
- Being tested
- CYSCONTROL/PHYTOCYST Herbal tea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYSCONTROL/PHYTOCYST Herbal teaCombination product
Alternating every month from Day1 to Day15 cyscontrol and phytocyst herbal tea to prevent episode of cystitis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: CYSCONTROL/PHYTOCYST Herbal tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12th month
Secondary outcomes (6)
Antibiotic treatments
The number of antibiotic treatments over 12 months
Measured: 12 months
Number of cystitis
The number of cystitis over the 12 months of the protocol
Measured: 12 months
Patients' overall satisfaction
Patients' overall satisfaction will be assessed on a simple numerical scale from 1 to 10. The scale is called the "General Satisfaction Scale" and ranges from 1 to 10. A score of 1 means not at all satisfied and 10 means very satisfied. As well as their ability to manage their symptoms. Three analogue scales will also be used to assess the impact of the protocol on patients' sexuality (including anxiety and comfort in relation to intercourse, when appropriate)
Measured: 12 months
Recording adverse events
The nature of the side effects, sought and at each phyto-aromatherapy consultation
Measured: 18 months
The benefit persisting at 6 months after stopping treatment with phyto-aromatherapy
The benefit persisting at 6 months after stopping treatment with phyto-aromatherapy will be evaluated on the number of times antibiotic therapy is used over a period of 6 months after stopping the treatment
Measured: During 6 months after stopping treatment (patient stop treatment at Month12 so between the 12th and 18th month)
Evaluation of the evolution of bacterial resistance on phenotypes isolated from the cytobacteriological examination of urine
Evaluation of the evolution of bacterial resistance on phenotypes isolated from the cytobacteriological examination of urine if inclusion resistance markers are present, in comparison with the last cytobacteriological examination of urine carried out during the protocol period, requested in the event of a clinical episode. A cytobacteriological examination of the urine carried out on a systematic basis that can detect asymptomatic colonisation or bacteriuria is not appropriate.
Measured: From date of inclusion until the date of documented episode of cystitis, assessed up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start18 May 2021
- Primary completion20 Jun 2023
- Study completion23 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystitis RecurrentStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Veronique MONDAIN, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747041
- Sponsor's protocol ID
- 17-AOIP-02
- Acronym
- CYSTALTERNA
- Status last verified
- Nov 2025
- First submitted
- 2 Feb 2021
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Phyto Aromatherapy Treatment in the Management of Recurrent Cystitis Preliminary Study
- ClinicalTrials.gov ID
- NCT04747041
- Acronym / sponsor ID
- CYSTALTERNA / 17-AOIP-02
- Conditions
- Cystitis Recurrent
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 18 May 2021 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 23 Jan 2026 (estimated)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alternating each month for 1 year between Phytocyst herbal tea and Cyscontrol | Experimental | Combination Product: CYSCONTROL/PHYTOCYST Herbal teaAlternating 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding women
- Severe visceral deficiencies in the previous year.
- Individualised psychiatric pathology.
- Other progressive infectious pathologies requiring antibiotic treatment.
- Taking anticoagulants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYSCONTROL/PHYTOCYST Herbal teaAlternating every month from Day1 to Day15 cyscontrol and phytocyst herbal tea to prevent episode of cystitis | Combination product | Alternating each month for 1 year between Phytocyst herbal tea and Cyscontrol |
Primary outcome
adherence to phyto-aromatherapy treatment
Time frame: 12th month
The scale called "treatment compliance" ranges from 1 to 10. A score of 1 means not at all observant and 10 means very observant.
6 secondary outcomes
Antibiotic treatments
Time frame: 12 months
Number of cystitis
Time frame: 12 months
Patients' overall satisfaction
Time frame: 12 months
Recording adverse events
Time frame: 18 months
The benefit persisting at 6 months after stopping treatment with phyto-aromatherapy
Time frame: During 6 months after stopping treatment (patient stop treatment at Month12 so between the 12th and 18th month)
Evaluation of the evolution of bacterial resistance on phenotypes isolated from the cytobacteriological examination of urine
Time frame: From date of inclusion until the date of documented episode of cystitis, assessed up to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronique MONDAIN principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Cystitis Recurrent, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adherence to phyto-aromatherapy treatment (time frame: 12th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.