Urinary tract infection and interstitial cystitis in women
Conditions
Interventions
The experimental group of patients with urinary tract infection :Vaginal flora transplantation
The control group of patients with urinary tract infection :Placebo
The experimental group of patients with interstitial cystitis :Vaginal flora transplantation
The control group of patients with interstitial cystitis :Placebo
Sponsors
Wuxi No.2 People's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Inclusion criteria for patients with urinary tract infection: a. =18 years old female; and current occurrence of urinary tract infection =3 times in the last year/=2 times in the last 6 months. b. =18 years old female; and =3 times in the last year/=2 times in the last 6 months. c. =18 years old female; and =2 times in the last 6 months. Diagnostic criteria for urinary tract infection: urine culture of the same colony =103cfu/mL, urinalysis WBC =10/mm3; signs of urinary tract irritation such as urinary frequency, urgency, and urinary pain, or lower abdominal tenderness and renal region percussion pain with or without fever. b. Voluntary participation in the study; c. Consciousness; and d. Ability to communicate verbally in a normal manner. (2) Inclusion criteria for patients with interstitial cystitis: a. Females =18 years of age; current and definitive diagnosis of interstitial cystitis. b. Patients with interstitial cystitis. c. Patients with interstitial cystitis. d. Patients with interstitial cystinosis. Diagnostic criteria for interstitial cystitis: signs of urinary tract irritation such as urinary frequency, urgency, and dysuria with or without pain and discomfort in the lower abdominal and perineal areas; normal urinalysis indexes; and none of the following exclusion criteria. b. Voluntary participation in the study; c. Consciousness; and d. Ability to communicate normally verbally. (3) Inclusion criteria for vaginal flora donors: a. Healthy females aged 18-30 years old, no bacterial or fungal infectious diseases in the vagina in the past three years, no history of urinary tract infection or interstitial cystitis, no sexual intercourse or invasive vaginal examination in the past three months; b. No history of drug and food allergy, no history of long-term medication; c. No underlying diseases, no autoimmune diseases, parasitic infections, or other disease states. d. No any of the exclusion criteria.
Exclusion criteria
Exclusion criteria: (1) Exclusion criteria for patients with urinary tract infections: a. Current indwelling catheterisation or history of catheterisation within 2 weeks; b. Use of antibiotics in the last 2 weeks; c. Use of probiotic preparations or synthetics in the last month; d. Interstitial cystitis, urinary stones, acute or chronic pyelonephritis, cystitis, history of malignant tumours of the genitourinary system, sexually transmitted diseases or other infectious diseases, history of uterovaginal surgery, history of vaginal inflammation or invasive vaginal examination within the last 6 months, previous enlargement of the bladder or cystectomy, generalised systemic conditions known to affect the lower urinary tract, a history of uterovaginal surgery, history of vaginal inflammation or invasive vaginal examination within the last 6 months, previous bladder enlargement or cystectomy, systemic neuromuscular disease known to affect the lower urinary tract, current or impending pregnancy/recent delivery <6 months, current pelvic floor physiotherapy, current opioid use or abdominal surgery within the last 6 months, urinary incontinence, urethral malformation bladder neck protrusion, pyelonephrosis, renal atrophy, tuberculosis, pregnancy, menstruation, breastfeeding, severe cardiovascular, hepatic, renal disease, mental abnormality. (2) Exclusion criteria for patients with interstitial cystitis: a. Currently undergoing indwelling urinary catheterisation or having a history of catheterisation within 2 weeks; b. Having used antibiotics in the last 2 weeks; c. Having used probiotic preparations or synthetics in the last month; d. Having the following conditions: infectious diseases of the urinary system, stones, history of malignant tumours of the genitoural system, sexually transmitted diseases or other infectious diseases, history of uterine-vaginal surgery, vaginal inflammatory diseases in the last 6 months. months, history of vaginal inflammation or invasive vaginal examination, previous bladder enlargement or cystectomy, systemic neuromuscular disease known to affect the lower urinary tract, current or impending pregnancy/last delivery <6 months, current pelvic floor physiotherapy, current use of opioids or abdominal surgery in the past 6 months, urinary incontinence, urethral malformations, protruding bladder neck, pyelonephrosis , renal atrophy, tuberculosis, pregnancy, menstruation, breastfeeding, severe cardiovascular, hepatic, renal disease, mental abnormality. (3) Exclusion criteria for vaginal flora donors: a. current indwelling catheterization or a history of catheterization within 2 weeks; b. Use of antibiotics in the last 2 weeks; c. Use of probiotics or synbiotics in the past month; d. Those who: A history of utero-vaginal surgery, previous cystoplasty or cystectomy, systemic neuromuscular disease known to affect the lower urinary tract, history of malignancy, current or imminent planning of pregnancy/most recent delivery <6 months, ongoing pelvic floor physiotherapy, current opioid use or abdominal surgery within the past 6 months, fever, Venereal or other infectious diseases, Urogenital inflammation, Calculi, Urinary incontinence, Urethral malformation, Bladder neck protrusion, Hydronephrosis, Renal atrophy, History of tuberculosis, Pregnancy, Menstrual period, lactation period, Severe cardiovascular disease, Mental disorder, systemic serious infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinalysis;Stool for routine;Amplification quantitative culture;Mass spectrum identification;16S rRNA sequence;Metagenome;Questionnaire;Cystoscopy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Glycosylated hemoglobin;Hepatic and renal function;C-reactive protein;Sex hormone;Endotoxin;Infectious disease indicators; | — |
Countries
China
Contacts
Public ContactNinghan Feng
Wuxi No.2 People's Hospital
Outcome results
None listed