Non-antibiotic alternative in the prophylaxis of recurrent urinary tract infections - AlP-FrUiT
Summary description of the study
This study is conducted at the Department of Urology and the Women's Clinic of the University Hospital of Basel. After consenting to participate, patients will be randomly assigned to either group "A=Bladder irrigations with hyaluronic acid-chondroitin sulfate (Ialuril®)" or group "B=Bladder irrigations with saline solution". In both groups, 7 bladder irrigations will be performed: in the first month weekly, in the second month every two weeks, concluding after one month. To ensure equivalent treatment for all patients, neither patients nor doctors know which group assignment is in place. At the beginning of the study, all patients will be given the opportunity to document additional symptoms and tolerability via an app or paper questionnaire. We plan to enroll 70 patients in the study over 10 months.
(BASEC)
Intervention under investigation
The study investigates preventive bladder irrigations (=prophylaxis) in patients with recurrent urinary tract infections.
(BASEC)
Disease under investigation
The study investigates preventive bladder irrigations (=prophylaxis) in patients with recurrent urinary tract infections.
(BASEC)
- recurrent urinary tract infections (defined as ≥ 3 episodes in the last year or 2 episodes in the last 6 months) - adult patient (≥18 years) (BASEC)
Exclusion criteria
- patients ≥ 70 years - no signed consent for study participation - urinary tract infection < 7 days before the start of the study - running antibiotic therapy or prophylaxis or any other prophylactic measure (BASEC)
Trial sites
Basel
(BASEC)
Sponsor
none
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. med. Hans Helge Seifert
+41 61 265 72 80
helge.seifert@clutterusb.chDepartment of Urology, University Hospital Basel
(BASEC)
General Information
Department of Urology, University Hospital Basel,
+41 61 265 72 80
helge.seifert@clutterusb.ch(ICTRP)
General Information
Department of Urology, University Hospital Basel
+41 61 265 72 80
helge.seifert@clutterusb.ch(ICTRP)
Scientific Information
Department of Urology, University Hospital Basel,
+41 61 265 72 80
helge.seifert@clutterusb.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
28.10.2019
(BASEC)
ICTRP Trial ID
NCT04095572 (ICTRP)
Official title (approved by ethics committee)
Non-antimicrobial alternative in prophylaxis of recurrent urinary tract infections: a prospective, randomised-controlled, double-blinded, multicentre study. (BASEC)
Academic title
Non-antimicrobial Alternative in Prophylaxis of Recurrent Urinary Tract Infections: a Prospective, Randomised-controlled, Double-blinded, Multicentre Study (ICTRP)
Public title
Alternative Prophylaxis in Female Recurrent Urinary Tract Infections (ICTRP)
Disease under investigation
Urinary Tract InfectionsUrinary Tract Infection (UTI) (ICTRP)
Intervention under investigation
Drug: intravesical instillation with HA-CSDrug: intravesical instillation of sterile purified water (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor). (ICTRP)
Inclusion/Exclusion criteria
Inclusion Criteria:
- Documented history of rUTI, defined as = 3 episodes of (un)complicated UTI
documented by urine culture with the isolation of =103 cfu/ml of an identified
pathogen in the last year with clinical symptoms OR 2 episodes in the last 6 month
Exclusion Criteria:
- No informed consent
- Concomitant UTI (< 7 days prior to randomisation)
- Ongoing antimicrobial prophylaxis (e.g. for rUTI or for any other reason like
endocarditis, transplanted patients under immunosuppression)
- Ongoing prophylactic strategy (e.g. immunoactive prophylaxis)
- Documented underlying urogenital abnormality (e.g. significant post voiding residual
volume (>50 ml), urethral stricture, urethral diverticula, urinary stone, reflux,
urinary neoplasia), urological device (e.g. catheter, ureteral stent) or symptomatic
pelvic floor disorder (e.g. genital prolapse stage = II)
- Concomitant disease (i.e. renal insufficiency, diabetes mellitus, corticosteroid
use)
- Urogenital urological or gynecological surgery < 6 weeks
- Known allergy to the study medication
- Use of spermicides or intrauterine device
- Pregnancy (ICTRP)
not available
Primary and secondary end points
Rate of symptomatic UTIs (based on clinical diagnosis) needing treatment with antimicrobials (ICTRP)
Symptomatic UTI (based on clinical diagnosis supported by measured bacteriuria of =103 cfu/ml) treated with antimicrobials;Symptoms of UTI according to the Acute Cystitis Symptom Score (ACSS) (cumulative number of each symptom);Time to UTI recurrence (as days between randomisation and the first recurring UTI);Asymptomatic bacteriuria of =105 cfu/ml;Detection of multidrug-resistant bacteria in urine culture (3Multiresistant gram negatives (MRGN), 4MRGN);Prescribed defined daily doses (DDD) of antibiotics (cumulative sum of DDD);Change in Pelvic Pain and Urinary/Frequency (PUF) Symptom Scale;Change in QoL Short Form (SF)-36 score (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
IBSA Institut Biochimique SA (ICTRP)
Additional contacts
Kathrin Bausch, Dr. med;Kathrin Bausch, Dr. med, kathrin.bausch@usb.ch, +41 61 265 72 80, Department of Urology, University Hospital Basel, (ICTRP)
Secondary trial IDs
2019-01377, me19Bausch (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT04095572 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available