- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03995797
VESPER: Pelvic Organ Prolapse Study (VESPER:POP)
Randomised, Sham Controlled Trial of Fotona Smooth Erbium Yag Laser In the Treatment of Pelvic Organ Prolapse.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- Adult Female, 18 years of age or older
- Clinical diagnosis of symptomatic stage 1-2 pelvic organ prolapse (PoPQ classification)
- Failed / declined conservative treatments, such as pelvic floor muscle training or vaginal pessaries
Exclusion Criteria:
Exclusion Criteria
- Pre-existing bladder pathology including prior radiation treatment
- Pregnancy
- BMI>35
- Radical pelvic surgery or previous incontinence surgery
- Urinary tract infection or other active infections of urinary tract or bladder
- Any form of pelvic organ prolapse greater than stage 2, according to POP-Q
- Diagnosis of collagen disorders eg.benign joint hypermobility / Elhers-Danlos / Marfans etc.
- Incomplete bladder emptying
- Vesicovaginal fistula
- Faecal incontinence
- Unwillingness or inability to complete follow-up schedule
- Unwillingness or inability to give Informed Consent
- Failure to comply with diary requirements during extended baseline period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Treatment arm
Treatment with erbium YAG laser
|
Erbium YAG laser
|
Placebo Comparator: Sham arm
Sub therapeutic procedure with erbium YAG laser
|
Erbium YAG laser
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pelvic Organ Prolapse Quantification Score (POP-Q) between baseline and 6 months after treatment.
Time Frame: 6 months
|
The change in Pelvic Organ Prolapse Quantification Score (PoP-Q)classification between baseline and 6 months, range = 0 - stage 4
|
6 months
|
Pelvic Organ Prolapse Quantification Score (POP-Q) between baseline and 12 months after treatment.
Time Frame: 12 months
|
The change in Pelvic Organ Prolapse Quantification Score (PoP-Q) classification between baseline and 12 months, range = 0 - stage 4
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mean International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS) test scores from baseline to 6 months post treatment
Time Frame: 6 months
|
Change in mean test scores from baseline to 6 months post treatment. Range: vaginal symptom scores (0-53), sexual matters scores (0-58), quality of life scores (0-10); higher score indicates greater severity of symptoms. |
6 months
|
Change in mean International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS) test scores from baseline to 12 months post treatment
Time Frame: 12 months
|
Change in mean test scores from baseline to 12 months post treatment. Range: vaginal symptom scores (0-53), sexual matters scores (0-58), quality of life scores (0-10); higher score indicates greater severity of symptoms. |
12 months
|
Patient's Global Impression of Improvement (PGI-I) at 6 months
Time Frame: 6 months
|
Questionnaire scores - range 1 (very much worse) to 7 (very much improved)
|
6 months
|
Patient's Global Impression of Improvement (PGI-I) at 12 months
Time Frame: 12 months
|
Questionnaire scores - range 1 (very much worse) to 7 (very much improved)
|
12 months
|
Change in mean Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) scores
Time Frame: 6 months
|
Change in mean test scores - range = 0 - 48; Higher value = increased sexual function, lower value = less sexual function
|
6 months
|
Change in mean Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) scores
Time Frame: 12 months
|
Change in mean test scores - range = 0 - 48; Higher value = increased sexual function, lower value = less sexual function
|
12 months
|
Pain visual analogue scale
Time Frame: 4 months
|
Patient reported assessment of pain on 10cm visual analogue scale during treatment, range 1 - 10cm; 0= no pain, 10= severe pain
|
4 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-FAM-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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