VESPER: Stress Urinary Incontinence STUDY

Study Overview
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Brief Summary
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Patients seen with stress urinary incontinence (SUI) that 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 prior to treatment and then at 6 and 12 months following the final treatment. At 6 months Sham patients will be un-blinded and offered the laser therapy if they wish.

Detailed Description
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All patients with urodynamically proven SUI, who have failed/declined conservative therapies and their history suggests mild to moderate SUI, will be informed about the study and consented if they wish. They will be invited to attend a screening visit. At this visit, they will be asked to perform a standardised 1 hour pad test. Their medical history will be checked and they will undergo a clinical and vaginal examination, pregnancy test and dip stick urinalysis.If their 1 hour pad weight is >2g and <25g and they meet all other inclusion / exclusion criteria, they will be eligible for inclusion. At the Baseline visit, the patient will have medical history confirmed, and be asked to complete a standing and supine (lying) cough test. They will be given the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) questionnaire. Patients will be randomised using a computer randomisation programme and blinded to their allocated arm: active treatment or sham treatment. Patients will then undergo 3 outpatient treatment visits. The timing of visits will be 1 month apart. At each visit they will be asked if they have any further questions and if they are happy to continue to participate in the study. If happy to participate, they will have their urine tested for infection (dipstick urinalysis) and pregnancy test at each treatment appointment. If urinalysis is negative, they will receive an outpatient Incontilase laser treatment. At each of their 3 outpatient appointments, they will be asked about any deleterious effects since their last appointment and asked to complete an ICIQ-SF and Patient Global Impression of Improvement questionnaire (treatment 2 onwards). Patients will receive 3 treatments in total. Patients will be invited to attend a follow up visits 6 & 12 months after the 3rd treatment and asked to complete ICIQ-SF, PISQ-12 and PGI-I symptom questionnaires and undergo a clinical examination. They will be asked to perform a cough test supine (lying) and standing and at 6 and 12 months also perform a 1 hour pad test as described earlier (see appendices). Patients randomised to the Sham arm will be un-blinded at 6 months and offered the treatment if they wish and followed up for six months.

Official Title
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Randomised, Sham Controlled Trial of Fotona Smooth Erbium Yag Laser In the Treatment of Stress Urinary Incontinence

Conditions
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Female Stress Incontinence

Intervention / Treatment
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* Procedure: Laser therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult Female, 18 years of age or older Clinical and UDS diagnosis of Stress Urinary Incontinence SUI on 1-hour Pad weight test between 2g and 25g (SUI I: 2-10g, SUI II:11-25g) No significant improvement in urinary incontinence from at least one previous conservative treatment, such as pelvic floor muscle training 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 SUI on 1 hour pad weight test >25g (SUI III: >25g) Any form of pelvic organ prolapse greater than stage 2, according to POP-Q Diagnosis of urge incontinence 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment arm<br>Therapeutic dose regime | Procedure: Laser therapy<br>* Erbium YAG laser<br>|
| Placebo Comparator: Sham arm<br>Sub-therapeutic dose regime | Procedure: Laser therapy<br>* Erbium YAG laser<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of 1hr pad weight test | The change in standardised 1hr pad weight test from baseline to 6 months following treatment compared with the sham arm. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cough stress test from baseline to 6 months post treatment | change in cough stress test (positive or negative, ie urine leakage or no leakage) | 6 months | 
| Change in cough stress test from baseline to 12 months post treatment | change in cough stress test (positive or negative, ie urine leakage or no leakage) | 12 months | 
| change in 1-hour pad weight test from baseline to 12 months post treatment | change in 1-hour pad weight test (urine leakage over 1hr measured in g) | 12 months | 
| International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) from baseline to 6 months post treatment | Change in mean test scores range = 0 - 21; low score = mild symptoms, high score = significant impact on quality of life | 6 months | 
| International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) from baseline to 12 months post treatment | Change in mean test scores range = 0 - 21; low score = mild symptoms, high score = significant impact on quality of life | 12 months | 
| Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) from baseline to 6 months post treatment | Change in mean test scores range = 0 - 48; Higher value = increased sexual function, lower value = less sexual function | 6 months | 
| Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) from baseline to 12 months post treatment | Change in mean test scores range = 0 - 48; Higher value = increased sexual function, lower value = less sexual function | 12 months | 
| Patient's Global Impression of Improvement (PGII) at 6 months post treatment | Assessments of patients' outcome of treatment; range 1 - 7; range 1 (very much worse) to 7 (very much improved) | 6 months | 
| Patient's Global Impression of Improvement (PGII) at 12 months post treatment | Assessments of patients' outcome of treatment; range 1 - 7; range 1 (very much worse) to 7 (very much improved) | 12 months | 
| Pain visual analogue scale | Patient reported assessment of pain on 10cm visual analogue scale during treatment, range 0 - 10cm; 0= no pain, 10= severe pain | 3 months |