Non-antibiotic alternative in the prophylaxis of recurrent urinary tract infections - AlP-FrUiT
Zusammenfassung der Studie
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)
Untersuchte Intervention
The study investigates preventive bladder irrigations (=prophylaxis) in patients with recurrent urinary tract infections.
(BASEC)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
- 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)
Studienstandort
Basel
(BASEC)
Sponsor
none
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Dr. med. Hans Helge Seifert
+41 61 265 72 80
helge.seifert@clutterusb.chDepartment of Urology, University Hospital Basel
(BASEC)
Allgemeine Auskünfte
Department of Urology, University Hospital Basel,
+41 61 265 72 80
helge.seifert@clutterusb.ch(ICTRP)
Allgemeine Auskünfte
Department of Urology, University Hospital Basel
+41 61 265 72 80
helge.seifert@clutterusb.ch(ICTRP)
Wissenschaftliche Auskünfte
Department of Urology, University Hospital Basel,
+41 61 265 72 80
helge.seifert@clutterusb.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
28.10.2019
(BASEC)
ICTRP Studien-ID
NCT04095572 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Non-antimicrobial alternative in prophylaxis of recurrent urinary tract infections: a prospective, randomised-controlled, double-blinded, multicentre study. (BASEC)
Wissenschaftlicher Titel
Non-antimicrobial Alternative in Prophylaxis of Recurrent Urinary Tract Infections: a Prospective, Randomised-controlled, Double-blinded, Multicentre Study (ICTRP)
Öffentlicher Titel
Alternative Prophylaxis in Female Recurrent Urinary Tract Infections (ICTRP)
Untersuchte Krankheit(en)
Urinary Tract InfectionsUrinary Tract Infection (UTI) (ICTRP)
Untersuchte Intervention
Drug: intravesical instillation with HA-CSDrug: intravesical instillation of sterile purified water (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
IBSA Institut Biochimique SA (ICTRP)
Weitere Kontakte
Kathrin Bausch, Dr. med;Kathrin Bausch, Dr. med, kathrin.bausch@usb.ch, +41 61 265 72 80, Department of Urology, University Hospital Basel, (ICTRP)
Sekundäre IDs
2019-01377, me19Bausch (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT04095572 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar