VESPER: PROLAPSE study
Research type
Research Study
Full title
VESPER: PROLAPSE (Vaginal Erbium laser in Stress incontinence, Prolapse, Estrogen deficiency and vaginal Relaxation: Stress Urinary Incontinence study): Randomised, Sham Controlled trial of Fotona Smooth Erbium Yag Laser In the treatment of Pelvic Organ Prolapse.
IRAS ID
264227
Contact name
Christian Phillips
Contact email
Sponsor organisation
Hampshire Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Patients seen with Stage 1-2 pelvic organ prolapse (POP) who have failed conservative treatments will be offered to participate in a sham controlled RCT of outpatient therapy with the Fotona Smooth Erbium Yag Laser. Patients will be randomised to either outpatient laser treatments or sham treatments. Patients will be blinded to which arm they have been randomised. Patients will be asked to complete appropriate relevant symptom and quality of life questionnaires and prolapse scoring, prior to treatment and at each monthly treatment and then 6 and 12 months following the final treatment. At 6 months following final treatment, Sham patients will be un-blinded and offered the laser therapy if they wish.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
19/WM/0136
Date of REC Opinion
4 Sep 2019
REC opinion
Further Information Favourable Opinion