Multicenter, prospective, randomized, placebo-controlled study after market approval with the Fotona Smooth Erbium:YAG laser for the treatment of stress urinary incontinence
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
Incontinence, stress urinary incontinence
(BASEC)
Women, 18 years and older, diagnosed with stress urinary incontinence, previously unsuccessful conservative therapy for stress urinary incontinence (BASEC)
Ausschlusskriterien
Pregnancy, severe obesity, any form of bladder pathology, severe prolapse (BASEC)
Studienstandort
Andere
(BASEC)
Frauenfeld
(BASEC)
Sponsor
Prof. Dr. med. Volker Viereck, Kantonsspital Frauenfeld
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Dr. med. Volker Viereck
+41 52 723 70 60
blasenzentrum.ksf@clutterstgag.chKantonsspital Frauenfeld
(BASEC)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Ostschweiz EKOS
(BASEC)
Datum der Bewilligung durch die Ethikkommission
06.01.2020
(BASEC)
ICTRP Studien-ID
NCT03996070 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Multicenter, Post-market, Prospective, Randomized, Sham-Controlled Trial of FotonaSmooth Erbium:YAG Laser in the Treatment of Stress Urinary Incontinence (BASEC)
Wissenschaftlicher Titel
Randomised, Sham Controlled Trial of Fotona Smooth Erbium Yag Laser In the Treatment of Stress Urinary Incontinence (ICTRP)
Öffentlicher Titel
VESPER: Stress Urinary Incontinence STUDY (ICTRP)
Untersuchte Krankheit(en)
Female Stress Incontinence
(ICTRP)
Untersuchte Intervention
Procedure: Laser therapy
(ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
28.03.2019 (ICTRP)
Einschluss des ersten Teilnehmers
01.09.2019 (ICTRP)
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
nicht verfügbar
Sekundäre IDs
2019-FAM-01 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
http://www.who.int/trialsearch/Trial2.aspx?TrialID=NCT03996070 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar