protocolSection identificationModule nctId: NCT06284265, orgStudyIdInfo id: MMH-407-007, briefTitle: Clinical Trial of the Efficacy and Safety of Raphamin in Prevention of Recurrences of Chronic Bacterial Cystitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-16, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Materia Medica Holding, class: INDUSTRY, descriptionModule briefSummary: Clinical Trial of the Efficacy and Safety of Raphamin in Prevention of Recurrences of Chronic Bacterial Cystitis, conditionsModule conditions: Cystitis Chronic, conditions: Cystitis Bacterial, conditions: Recurrence of Chronic Bacterial Cystitis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 632, type: ESTIMATED, armsInterventionsModule interventions name: Raphamin, interventions name: Placebo, outcomesModule primaryOutcomes measure: Time to the first recurrence of chronic bacterial cystitis, secondaryOutcomes measure: Percentage of patients with a reduction of recurrences of chronic bacterial cystitis, otherOutcomes measure: Average duration of episodes of recurrences of chronic bacterial cystitis, otherOutcomes measure: Average number of recurrences of chronic bacterial cystitis, otherOutcomes measure: Severity of chronic bacterial cystitis recurrences, otherOutcomes measure: Change in the severity of chronic bacterial cystitis recurrences, otherOutcomes measure: VAS score at the end of the follow-up period, otherOutcomes measure: The Presence of Adverse Events (AEs)., otherOutcomes measure: Changes in Vital Signs (Blood Pressure measured in mm Hg), otherOutcomes measure: Changes in Vital Signs (Pulse Rate (Heart Rate) measured in beats per minute), otherOutcomes measure: Changes in Vital Signs (Respiration Rate (Breathing Rate) measured in breaths per minute), otherOutcomes measure: Proportion of patients with clinically significant laboratory abnormalities, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Scientific Center for Family Health and Human Reproduction Problems/Reproductive Health Department, status: RECRUITING, city: Irkutsk, zip: 664003, country: Russian Federation, contacts name: Larisa Suturina, Prof., role: CONTACT, contacts name: Larisa Suturina, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.29778, lon: 104.29639, locations facility: Kazan State Medical University/Professor's clinic, status: NOT_YET_RECRUITING, city: Kazan, zip: 420012, country: Russian Federation, contacts name: Ruslan Fatykhov, MD, PhD, role: CONTACT, contacts name: Ruslan Fatykhov, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.78874, lon: 49.12214, locations facility: LLC "Fenareta" Women's and Men's Health Clinic", status: RECRUITING, city: Kemerovo, zip: 650000, country: Russian Federation, contacts name: Natalia Artymuk, Prof., role: CONTACT, contacts name: Natalia Artymuk, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.33333, lon: 86.08333, locations facility: City Clinical Hospital #15 named after O.M. Filatov Department of Health of Moscow, status: RECRUITING, city: Moscow, zip: 111539, country: Russian Federation, contacts name: Vladimir Kuzmin, Prof., role: CONTACT, contacts name: Vladimir Kuzmin, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, locations facility: City Clinical Hospital # 13/Gynecology Department # 1, status: RECRUITING, city: Moscow, zip: 115280, country: Russian Federation, contacts name: Felix Grigoryan, PhD, role: CONTACT, contacts name: Felix Grigoryan, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Clinical Hospital # 85 of the Federal Medical and Biological Agency/Central polyclinic, status: RECRUITING, city: Moscow, zip: 115409, country: Russian Federation, contacts name: Sergey Levakov, Prof., role: CONTACT, contacts name: Sergey Levakov, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Research Institute of Rheumatology named after V.A. Nasonova, status: RECRUITING, city: Moscow, zip: 115522, country: Russian Federation, contacts name: Victoria Gelashvili, MD, role: CONTACT, contacts name: Victoria Gelashvili, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, locations facility: National Medical Research Center for Obstetrics, Gynecology and Perinatology named after V.I. Kulakov/Department of Aesthetic Gynecology and Rehabilitation, status: RECRUITING, city: Moscow, zip: 117198, country: Russian Federation, contacts name: Inna Apolikhina, Prof., role: CONTACT, contacts name: Inna Apolikhina, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Peoples' Friendship University of Russia/Department of Obstetrics and Gynecology with a course in perinatology, status: WITHDRAWN, city: Moscow, zip: 117198, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Russian National Research Medical University named after N.I. Pirogov/Department of Obstetrics and Gynecology, Faculty of Medicine, status: RECRUITING, city: Moscow, zip: 117997, country: Russian Federation, contacts name: Yulia Dobrokhotova, Prof., role: CONTACT, contacts name: Yulia Dobrokhotova, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, locations facility: City Clinical Hospital # 1 named after. N.I. Pirogov of the Moscow City Health Department, status: RECRUITING, city: Moscow, zip: 119049, country: Russian Federation, contacts name: Sergey Kotov, PhD, MD, role: CONTACT, contacts name: Sergey Kotov, PhD, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, locations facility: United hospital with clinic of the Administration of the President of the Russian Federation, status: NOT_YET_RECRUITING, city: Moscow, zip: 119285, country: Russian Federation, contacts name: Nikolay Keshishev, MD, PhD, role: CONTACT, contacts name: Nikolay Keshishev, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, locations facility: City Clinical Hospital # 67 named after L.A. Vorokhobov, status: NOT_YET_RECRUITING, city: Moscow, zip: 121423, country: Russian Federation, contacts name: Olga Perevozkina, MD, PhD, role: CONTACT, contacts name: Olga Perevozkina, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, locations facility: JSC "MEDSI Group of Companies", status: WITHDRAWN, city: Moscow, zip: 123056, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Moscow State Medical and Dental University named after A.I. Evdokimov/Department of Urologya, status: RECRUITING, city: Moscow, zip: 127473, country: Russian Federation, contacts name: Dmitry Pushkar, Prof., role: CONTACT, contacts name: Dmitry Pushkar, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Privolzhsky District Medical Center, status: RECRUITING, city: Nizhny Novgorod, zip: 603001, country: Russian Federation, contacts name: Vagif Atduev, Prof., role: CONTACT, contacts name: Vagif Atduev Vagif, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 56.32867, lon: 44.00205, locations facility: National Medical Research Center for Radiology/Research Institute of Urology and Interventional Radiology named after. N.A. Lopatkin, status: NOT_YET_RECRUITING, city: Obninsk, zip: 105425, country: Russian Federation, contacts name: Tatyana Perepanova, Prof., role: CONTACT, contacts name: Tatyana Perepanova, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.09681, lon: 36.61006, locations facility: City Clinical Hospital, status: NOT_YET_RECRUITING, city: Pyatigorsk, zip: 357500, country: Russian Federation, contacts name: Alexander Bardin, MD, role: CONTACT, contacts name: Alexander Bardin, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.04861, lon: 43.05944, locations facility: Clinical and Diagnostic Center "Health" in Rostov-on-Don, status: RECRUITING, city: Rostov-on-Don, zip: 344011, country: Russian Federation, contacts name: Igor Aboyan, Prof., role: CONTACT, contacts name: Igor Aboyan, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.23135, lon: 39.72328, locations facility: Rostov State Medical University/Department of Urology and Human Reproductive Health with a course of pediatric urology-andrology, status: RECRUITING, city: Rostov-on-Don, zip: 344022, country: Russian Federation, contacts name: Mikhail Kogan, Prof., role: CONTACT, contacts name: Mikhail Kogan, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.23135, lon: 39.72328, locations facility: Rostov Central District Hospital, status: NOT_YET_RECRUITING, city: Rostov, zip: 152155, country: Russian Federation, contacts name: Ariz Gyulmamedov, MD, role: CONTACT, contacts name: Ariz Gyulmamedov, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 57.1914, lon: 39.41394, locations facility: JSC "Polyclinic Complex", status: WITHDRAWN, city: Saint Petersburg, zip: 190013, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: LLC "Medical Center Capital-Polis", status: NOT_YET_RECRUITING, city: Saint Petersburg, zip: 190013, country: Russian Federation, contacts name: Dmitry Gorelov, MD, role: CONTACT, contacts name: Dmitry Gorelov, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.93863, lon: 30.31413, locations facility: LLC "BioTechService", status: RECRUITING, city: Saint Petersburg, zip: 190121, country: Russian Federation, contacts name: Alexander Parshin, PhD, role: CONTACT, contacts name: Alexander Parshin, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.93863, lon: 30.31413, locations facility: City clinic # 44, status: NOT_YET_RECRUITING, city: Saint Petersburg, zip: 192071, country: Russian Federation, contacts name: Farzali Farzaliev, MD, role: CONTACT, contacts name: Farzali Farzaliev, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.93863, lon: 30.31413, locations facility: All-Russian Center for Emergency and Radiation Medicine named after A.M. Nikiforov/Urology department, status: RECRUITING, city: Saint Petersburg, zip: 194044, country: Russian Federation, contacts name: Vladislav Grigoriev, PhD, role: CONTACT, contacts name: Vladislav Grigoriev, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.93863, lon: 30.31413, locations facility: St. Luke's Clinical Hospital, status: RECRUITING, city: Saint Petersburg, zip: 194044, country: Russian Federation, contacts name: Orlov Igor, PhD, role: CONTACT, contacts name: Orlov Igor, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.93863, lon: 30.31413, locations facility: City Multidisciplinary Hospital # 2/Urology department, status: WITHDRAWN, city: Saint Petersburg, zip: 194354, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Llc "Medical Clinic", status: RECRUITING, city: Saint Petersburg, zip: 194356, country: Russian Federation, contacts name: Maxim Bushara, MD, role: CONTACT, contacts name: Maxim Bushara, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Medical and sanitary unit No. 70 - branch of the St. Petersburg State Unitary Enterprise of Passenger Road Transport, status: RECRUITING, city: Saint Petersburg, zip: 195197, country: Russian Federation, contacts name: Vadim Zubarev, PhD, MD, role: CONTACT, contacts name: Vadim Zubarev, PhD, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.93863, lon: 30.31413, locations facility: LLC "Research Center Eco-Safety", status: TERMINATED, city: Saint Petersburg, zip: 196143, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Jsc "Northwestern Center of Evidence-Based Medicine", status: WITHDRAWN, city: Saint Petersburg, zip: 196158, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: City Hospital # 15, status: NOT_YET_RECRUITING, city: Saint Petersburg, zip: 198205, country: Russian Federation, contacts name: Konstantin Dunets, MD, role: CONTACT, contacts name: Konstantin Dunets, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Research Institute of Obstetrics, Gynecology and Reproductology named after D.O. Ott/Department of Gynecology and Endocrinology, status: RECRUITING, city: Saint Petersburg, zip: 199034, country: Russian Federation, contacts name: Maria Yarmolinskaya, Prof., role: CONTACT, contacts name: Maria Yarmolinskaya, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.93863, lon: 30.31413, locations facility: City Pokrovskaya Hospital/Department of Urology, status: RECRUITING, city: Saint Petersburg, zip: 199106, country: Russian Federation, contacts name: Andrey Gorelov, Prof., role: CONTACT, contacts name: Andrey Gorelov, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Sertolovo City Hospital, status: NOT_YET_RECRUITING, city: Sertolovo, zip: 188650, country: Russian Federation, contacts name: Alexander Shvets, MD, role: CONTACT, contacts name: Alexander Shvets, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 60.1444, lon: 30.20165, locations facility: Siberian State Medical University/Faculty clinics of Siberian State Medical University, status: NOT_YET_RECRUITING, city: Tomsk, zip: 634050, country: Russian Federation, contacts name: Victor Latypov, MD, PhD, role: CONTACT, contacts name: Victor Latypov, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 56.49771, lon: 84.97437, locations facility: Bashkir State Medical University/Department of Obstetrics and Gynecology # 1, status: WITHDRAWN, city: Ufa, zip: 450008, country: Russian Federation, geoPoint lat: 54.74306, lon: 55.96779, locations facility: Voronezh State Medical University named after N.N. Burdenko/Department of Urology, status: RECRUITING, city: Voronezh, zip: 394036, country: Russian Federation, contacts name: Andrey Kuzmenko, Prof., role: CONTACT, contacts name: Andrey Kuzmenko, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.67204, lon: 39.1843, locations facility: Vsevolozhsk Clinical Interdistrict Hospital/Center for Outpatient Surgery, status: RECRUITING, city: Vsevolozhsk, zip: 188643, country: Russian Federation, contacts name: Nikolay Kanareikin, MD, role: CONTACT, contacts name: Nikolay Kanareikin, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 60.01512, lon: 30.67314, locations facility: Yaroslavl State Medical University/Department of Urology and Nephrology, status: NOT_YET_RECRUITING, city: Yaroslavl, zip: 150000, country: Russian Federation, contacts name: Igor Shormanov, Prof., role: CONTACT, contacts name: Igor Shormanov, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 57.62987, lon: 39.87368, locations facility: LLC "Clinic of Modern Medicine Dr. Bogorodskaya", status: NOT_YET_RECRUITING, city: Yaroslavl, zip: 150001, country: Russian Federation, contacts name: Andrey Soloviev, MD, PhD, role: CONTACT, contacts name: Andrey Soloviev, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 57.62987, lon: 39.87368, locations facility: LLC "Medical Center for Diagnosis and Prevention Plus", status: RECRUITING, city: Yaroslavl, zip: 150040, country: Russian Federation, contacts name: Svetlana Isakova, MD, role: CONTACT, contacts name: Svetlana Isakova, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 57.62987, lon: 39.87368, locations facility: Regional Clinical Hospital/Urology department, status: RECRUITING, city: Yaroslavl, zip: 150062, country: Russian Federation, contacts name: Dmitry Komlev, PhD, role: CONTACT, contacts name: Dmitry Komlev, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 57.62987, lon: 39.87368, hasResults: False