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
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.
Summary of Results:
Can Vaginal Laser Help Women with Stress Urinary Incontinence?
Stress urinary incontinence (SUI) is the accidental leakage of urine during activities that increase pressure on the bladder, such as coughing, sneezing, laughing or exercising. It affects millions of women and can have a major impact on confidence, exercise and quality of life.
This international clinical trial was designed to find out whether non ablative Erbium vaginal laser treatment was genuinely effective or whether any improvement was simply due to a placebo (sham) effect. The study took place in specialist urogynecology centres in the UK, Switzerland and Germany and is considered one of the highest-quality studies performed in this field because women were randomly assigned to receive either active laser treatment or an identical sham procedure, without knowing which treatment they had received.
A total of 79 women with mild to moderate stress urinary incontinence took part. Each woman received three treatment sessions and was followed for six months after completing treatment.
The results showed that almost two-thirds (63%) of women treated with the laser achieved a clinically meaningful improvement, compared with only 18% of women receiving the sham treatment. Women treated with the laser also experienced significantly less urine leakage on pad testing, improved symptom scores and better quality of life, including improvements in sexual function. Importantly, women receiving the sham treatment did not show similar improvements.
The treatment was well tolerated, with no serious treatment-related complications reported during the study. Most women experienced little discomfort and returned to normal activities immediately afterwards.
Overall, this study provides strong evidence that non-ablative Erbium vaginal laser therapy can improve symptoms in carefully selected women with mild to moderate stress urinary incontinence.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