VESPER: Stress Urinary Incontinence STUDY (VESPER-SUI)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Female Stress Incontinence
• Intervention / Treatment: Procedure: Laser therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 23
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Victoria Corner; Phone Number: +4424127; Email: Victoria.Corner@hhft.nhs.uk
• Study Contact Backup: Name: Clare Rowe Jones; Phone Number: +441256862417; Email: Clare.Rowejones@hhft.nhs.uk

Study Locations

• United Kingdom
  • Hampshire
    • Basingstoke, Hampshire, United Kingdom, RG24 9NA
      • Recruiting
      • Basingstoke & North Hampshire Hospital
      • Contact: Victoria Corner; Phone Number: +4424127; Email: Victoria.Corner@hhft.nhs.uk
      • Contact: Clare Rowe Jones; Phone Number: +11 1356 862417; Email: Clare.Rowejones@hhft.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Adult Female, 18 years of age or older
2. Clinical and UDS diagnosis of Stress Urinary Incontinence
3. SUI on 1-hour Pad weight test between 2g and 25g (SUI I: 2-10g, SUI II:11-25g)
4. No significant improvement in urinary incontinence from at least one previous conservative treatment, such as pelvic floor muscle training

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. SUI on 1 hour pad weight test >25g (SUI III: >25g)
7. Any form of pelvic organ prolapse greater than stage 2, according to POP-Q
8. Diagnosis of urge incontinence
9. Diagnosis of collagen disorders eg.benign joint hypermobility / Elhers-Danlos / Marfans etc.
10. Incomplete bladder emptying
11. Vesicovaginal fistula
12. Faecal incontinence
13. Unwillingness or inability to complete follow-up schedule
14. Unwillingness or inability to give Informed Consent
15. 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
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Treatment arm; Therapeutic dose regime	Procedure: Laser therapy; Erbium YAG laser
PLACEBO_COMPARATOR: Sham arm; Sub-therapeutic dose regime	Procedure: Laser therapy; Erbium YAG laser

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hampshire Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Christian Phillips, Hampshire Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 6, 2022
• Primary Completion (ANTICIPATED): June 6, 2024
• Study Completion (ANTICIPATED): March 30, 2025

Study Registration Dates

• First Submitted: March 28, 2019
• First Submitted That Met QC Criteria: June 21, 2019
• First Posted (ACTUAL): June 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2023
• Last Update Submitted That Met QC Criteria: January 30, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 2019-FAM-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No