Non-antibiotic alternative in the prophylaxis of recurrent urinary tract infections - AlP-FrUiT
Descrizione riassuntiva dello studio
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)
Intervento studiato
The study investigates preventive bladder irrigations (=prophylaxis) in patients with recurrent urinary tract infections.
(BASEC)
Malattie studiate
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)
Criteri di esclusione
- 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)
Luogo dello studio
Basilea
(BASEC)
Sponsor
none
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Dr. med. Hans Helge Seifert
+41 61 265 72 80
helge.seifert@clutterusb.chDepartment of Urology, University Hospital Basel
(BASEC)
Informazioni generali
Department of Urology, University Hospital Basel,
+41 61 265 72 80
helge.seifert@clutterusb.ch(ICTRP)
Informazioni generali
Department of Urology, University Hospital Basel
+41 61 265 72 80
helge.seifert@clutterusb.ch(ICTRP)
Informazioni scientifiche
Department of Urology, University Hospital Basel,
+41 61 265 72 80
helge.seifert@clutterusb.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
28.10.2019
(BASEC)
ID di studio ICTRP
NCT04095572 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Non-antimicrobial alternative in prophylaxis of recurrent urinary tract infections: a prospective, randomised-controlled, double-blinded, multicentre study. (BASEC)
Titolo accademico
Non-antimicrobial Alternative in Prophylaxis of Recurrent Urinary Tract Infections: a Prospective, Randomised-controlled, Double-blinded, Multicentre Study (ICTRP)
Titolo pubblico
Alternative Prophylaxis in Female Recurrent Urinary Tract Infections (ICTRP)
Malattie studiate
Urinary Tract InfectionsUrinary Tract Infection (UTI) (ICTRP)
Intervento studiato
Drug: intravesical instillation with HA-CSDrug: intravesical instillation of sterile purified water (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
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)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
IBSA Institut Biochimique SA (ICTRP)
Contatti aggiuntivi
Kathrin Bausch, Dr. med;Kathrin Bausch, Dr. med, kathrin.bausch@usb.ch, +41 61 265 72 80, Department of Urology, University Hospital Basel, (ICTRP)
ID secondari
2019-01377, me19Bausch (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT04095572 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile