Clinical trial NCT03995797: VESPER: Pelvic Organ Prolapse Study
Official title: Randomised, Sham Controlled Trial of Fotona Smooth Erbium Yag Laser In the Treatment of Pelvic Organ Prolapse.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: Hampshire Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-06-24
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: All patients with symptomatic stage 1-2 POP, who have failed / declined conservative therapy will be informed about the study and invited to participate.

Once eligibility for inclusion into the study has been confirmed and written consent has been obtained, the patient will be invited for a baseline visit. At this visit the patient will have their medical history confirmed and have all Pelvic Organ Prolapse Quantification Score (PoP-Q) measurements made. They will be given the ICIQ Vaginal Symptom (ICIQ-VS) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) questionnaire.

Patients will be randomised and blinded to their allocated arm: active treatment or sham treatment (2:1, treatment : Sham).

Patients will then undergo 4 outpatient treatment visits. The timing of visits will be from 1 month apart. Before each treatment, they will have their urine tested for infection (dipstick urinalysis) and a pregnancy test (not required if had hysterectomy / sterilised). If urinalysis is negative, they will be receive an outpatient ProlapLase treatment which lasts 20 minutes. They will be given a leaflet outlining what to expect and a contact number if they have any concerns or questions. They will be asked about any deleterious effects since their last appointment, have a PoPQ score recorded and asked to complete a Patient Global Impression of Improvement (PGI-I) questionnaire. Patients will routinely receive 4 treatments. Each treatment will be 4 weeks apart.

Patients will be invited to attend a follow up visit 6 months after the 4th treatment. They will be asked if they are happy to continue to participate in the trial and if happy, asked to complete International Consultation on Incontinence Questionnaire (ICIQ-VS), Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) and Patient Global Impression of Improvement (PGI-I) symptom questionnaires and undergo a Pelvic Organ Prolapse Quantification Score (PoP-Q) score. Patients will be asked about any Adverse Event / Serious Adverse Event since involvement in the study. Patients randomised to the Sham arm will be un-blinded at 6 months and offered the treatments (x4) if they wish. They will then be followed up at 6 and 12 months after treatment.

Eligibility criteria: Inclusion Criteria

1. Adult Female, 18 years of age or older
2. Clinical diagnosis of symptomatic stage 1-2 pelvic organ prolapse (PoPQ classification)
3. Failed / declined conservative treatments, such as pelvic floor muscle training or vaginal pessaries

Exclusion Criteria:

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. Any form of pelvic organ prolapse greater than stage 2, according to POP-Q
7. Diagnosis of collagen disorders eg.benign joint hypermobility / Elhers-Danlos / Marfans etc.
8. Incomplete bladder emptying
9. Vesicovaginal fistula
10. Faecal incontinence
11. Unwillingness or inability to complete follow-up schedule
12. Unwillingness or inability to give Informed Consent
13. Failure to comply with diary requirements during extended baseline period

Primary outcomes:
measure: Pelvic Organ Prolapse Quantification Score (POP-Q) between baseline and 6 months after treatment.
timeFrame: 6 months
measure: Pelvic Organ Prolapse Quantification Score (POP-Q) between baseline and 12 months after treatment.
timeFrame: 12 months
Secondary outcomes:
measure: Change in mean International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS) test scores from baseline to 6 months post treatment
timeFrame: 6 months
measure: Change in mean International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS) test scores from baseline to 12 months post treatment
timeFrame: 12 months
measure: Patient's Global Impression of Improvement (PGI-I) at 6 months
timeFrame: 6 months
measure: Patient's Global Impression of Improvement (PGI-I) at 12 months
timeFrame: 12 months
measure: Change in mean Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) scores
timeFrame: 6 months
measure: Change in mean Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) scores
timeFrame: 12 months
measure: Pain visual analogue scale
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
References: