Multicenter, prospective, randomized, placebo-controlled study after market approval with the Fotona Smooth Erbium:YAG laser for the treatment of stress urinary incontinence
Descrizione riassuntiva dello studio
In this study, we aim to investigate the efficacy and tolerability of laser therapy for stress urinary incontinence. Initial clinical studies showed that it is a simple, effective, and safe procedure. Study participants will be randomly assigned to two groups. Two-thirds of the participants will receive active laser therapy, one-third will be treated with a placebo laser, so we can determine the difference. The participants will not know which group they have been assigned to during the treatment phase, but those treated with placebo will be offered active laser therapy after the first completed treatment phase as part of the study. The laser therapy will take place in three sessions of approximately 30 minutes each. Follow-up will occur six and twelve months after treatment.
(BASEC)
Intervento studiato
Laser therapy: A total of three laser sessions are planned at intervals of six weeks each. A laser treatment occurs in three steps: laser treatment of the anterior vaginal wall, laser treatment of the entire vaginal wall, laser treatment of the outer region around the vaginal entrance.
Placebo therapy: the procedure is the same, but a special setting on the laser device completely blocks the laser beam, so it has no effect.
(BASEC)
Malattie studiate
Incontinence, stress urinary incontinence
(BASEC)
Women, 18 years and older, diagnosed with stress urinary incontinence, previously unsuccessful conservative therapy for stress urinary incontinence (BASEC)
Criteri di esclusione
Pregnancy, severe obesity, any form of bladder pathology, severe prolapse (BASEC)
Luogo dello studio
Altro
(BASEC)
Frauenfeld
(BASEC)
Sponsor
Prof. Dr. med. Volker Viereck, Kantonsspital Frauenfeld
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Dr. med. Volker Viereck
+41 52 723 70 60
blasenzentrum.ksf@clutterstgag.chKantonsspital Frauenfeld
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Ethikkommission Ostschweiz EKOS
(BASEC)
Data di approvazione del comitato etico
06.01.2020
(BASEC)
ID di studio ICTRP
NCT03996070 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Multicenter, Post-market, Prospective, Randomized, Sham-Controlled Trial of FotonaSmooth Erbium:YAG Laser in the Treatment of Stress Urinary Incontinence (BASEC)
Titolo accademico
Randomised, Sham Controlled Trial of Fotona Smooth Erbium Yag Laser In the Treatment of Stress Urinary Incontinence (ICTRP)
Titolo pubblico
VESPER: Stress Urinary Incontinence STUDY (ICTRP)
Malattie studiate
Female Stress Incontinence
(ICTRP)
Intervento studiato
Procedure: Laser therapy
(ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant). (ICTRP)
Criteri di inclusione/esclusione
Inclusion Criteria: 1. Adult Female, 18 years of age or older 2. Clinical and UDS diagnosis of Stress Urinary Incontinence 3. SUI on 1-hour Pad weight test between 2g and 25g (SUI I: 2-10g, SUI II:11-25g) 4. No significant improvement in urinary incontinence from at least one previous conservative treatment, such as pelvic floor muscle training Exclusion Criteria: 1. Pre-existing bladder pathology including prior radiation treatment 2. Pregnancy 3. BMI>35 4. Radical pelvic surgery or previous incontinence surgery 5. Urinary tract infection or other active infections of urinary tract or bladder 6. SUI on 1 hour pad weight test >25g (SUI III: >25g) 7. Any form of pelvic organ prolapse greater than stage 2, according to POP-Q 8. Diagnosis of urge incontinence 9. Diagnosis of collagen disorders eg.benign joint hypermobility / Elhers-Danlos / Marfans etc. 10. Incomplete bladder emptying 11. Vesicovaginal fistula 12. Faecal incontinence 13. Unwillingness or inability to complete follow-up schedule 14. Unwillingness or inability to give Informed Consent 15. Failure to comply with diary requirements during extended baseline period
Minimum age: 18 Years
Maximum age: N/A
Sex: Female (ICTRP)
non disponibile
Endpoint primari e secondari
Assessment of 1hr pad weight test
(ICTRP)
change in 1-hour pad weight test from baseline to 12 months post treatment
Change in cough stress test from baseline to 12 months post treatment
Change in cough stress test from baseline to 6 months post treatment
International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) from baseline to 12 months post treatment
International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) from baseline to 6 months post treatment
Pain visual analogue scale
Patient's Global Impression of Improvement (PGII) at 12 months post treatment
Patient's Global Impression of Improvement (PGII) at 6 months post treatment
Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) from baseline to 12 months post treatment
Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) from baseline to 6 months post treatment
(ICTRP)
Data di registrazione
28.03.2019 (ICTRP)
Inclusione del primo partecipante
01.09.2019 (ICTRP)
Sponsor secondari
non disponibile
Contatti aggiuntivi
non disponibile
ID secondari
2019-FAM-01 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
http://www.who.int/trialsearch/Trial2.aspx?TrialID=NCT03996070 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile