Active — Not RecruitingPhase 3

Clinical Trial of the Efficacy and Safety of Raphamin in Prevention of Recurrences of Chronic Bacterial Cystitis

Russia415 participantsStarted 2023-10-16

Plain-language summary

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Female patients aged 18 years and older.
✓. Patients with a confirmed diagnosis of chronic bacterial cystitis.
✓. Patients with exacerbation of chronic cystitis based on typical symptoms of exacerbation of the disease with a severity of 7 points or more in accordance wuth ACSS.
✓. The first 48 hours from the onset of exacerbation) of chronic bacterial cystitis.
✓. Patients who agreed to use an acceptable method of contraception during the study (for women of reproductive potential).
✓. Availability of a signed patient information sheet and informed consent form for participation in the clinical trial.

✕. Presence of urolithiasis, urinary tract obstruction, urothelial cancer, pelvic organ prolapse, neurogenic bladder disorders at the time of examination.
✕. Presence of malignant neoplasms of the urinary tract, ureter stone, more than 50 ml of residual urine in the bladder, confirmed by ultrasound examination.
✕. Suspicion of bladder tuberculosis.
✕. Presence of indications for hospitalization due to a serious condition, macrohematuria, complicated cystitis.
✕. Decompensation of diabetes mellitus, immunodeficiency of any etiology, malignant cancer of any localization, severe circulatory insufficiency (cardiovascular disease with functional class IV according to the classification of the New York Heart Association, 1964).

Time to the first recurrence of chronic bacterial cystitis

Timeframe: 6 months

NCT IDNCT06284265

SponsorMateria Medica Holding

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Female patients aged 18 years and older.
✓. Patients with a confirmed diagnosis of chronic bacterial cystitis.
✓. Patients with exacerbation of chronic cystitis based on typical symptoms of exacerbation of the disease with a severity of 7 points or more in accordance wuth ACSS.
✓. The first 48 hours from the onset of exacerbation) of chronic bacterial cystitis.
✓. Patients who agreed to use an acceptable method of contraception during the study (for women of reproductive potential).
✓. Availability of a signed patient information sheet and informed consent form for participation in the clinical trial.

✕. Presence of urolithiasis, urinary tract obstruction, urothelial cancer, pelvic organ prolapse, neurogenic bladder disorders at the time of examination.
✕. Presence of malignant neoplasms of the urinary tract, ureter stone, more than 50 ml of residual urine in the bladder, confirmed by ultrasound examination.
✕. Suspicion of bladder tuberculosis.
✕. Presence of indications for hospitalization due to a serious condition, macrohematuria, complicated cystitis.
✕. Decompensation of diabetes mellitus, immunodeficiency of any etiology, malignant cancer of any localization, severe circulatory insufficiency (cardiovascular disease with functional class IV according to the classification of the New York Heart Association, 1964).