Female Stress IncontinenceVESPER-SUINCT03996070
VESPER: Stress Urinary Incontinence STUDY
A study testing Laser therapy in people with Female Stress Incontinence, run by Hampshire Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Female Stress Incontinence
- What is being tested?
- Laser therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jun 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Basingstoke & North Hampshire Hospital
Basingstoke, Hampshire, RG24 9NA
About this study
Official title: 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.
Read the 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.
- Conditions
- Female Stress Incontinence
- Being tested
- Laser therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser therapyProcedure or surgery
Erbium YAG laser
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Active comparator | Therapeutic dose regime Receives: Procedure: Laser therapy |
| Sham arm | Placebo comparator | Sub-therapeutic dose regime Receives: Procedure: Laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (10)
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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start6 Jun 2022
- Primary completion30 Nov 2024
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Female Stress IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hampshire Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Phillips, Principal investigator, Hampshire Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996070
- Sponsor's protocol ID
- 2019-FAM-01
- Acronym
- VESPER-SUI
- Status last verified
- Sep 2025
- First submitted
- 28 Mar 2019
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Phillips C, Shah G, Gamper M, Kuszka A, Chandrakumaran K, Viereck V. Vaginal Erbium Laser for the Treatment of Mild-to-Moderate Stress Urinary Incontinence: A Multicentre Randomised Sham-Controlled Trial. BJOG. 2026 Mar;133(4):609-617. doi: 10.1111/1471-0528.70080. Epub 2025 Nov 12.
PubMed 41221700Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.
PubMed 40709601
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Sham Controlled Trial of Fotona Smooth Erbium Yag Laser In the Treatment of Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT03996070
- Acronym / sponsor ID
- VESPER-SUI / 2019-FAM-01
- Conditions
- Female Stress Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hampshire Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 24 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Active comparator | Procedure: Laser therapyTherapeutic dose regime |
| Sham arm | Placebo comparator | Procedure: Laser therapySub-therapeutic dose regime |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser therapyErbium YAG laser | Procedure or surgery | Sham arm, Treatment arm |
Primary outcome
Assessment of 1hr pad weight test
Time frame: 6 months
The change in standardised 1hr pad weight test from baseline to 6 months following treatment compared with the sham arm.
10 secondary outcomes
Change in cough stress test from baseline to 6 months post treatment
Time frame: 6 months
Change in cough stress test from baseline to 12 months post treatment
Time frame: 12 months
change in 1-hour pad weight test from baseline to 12 months post treatment
Time frame: 12 months
International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) from baseline to 6 months post treatment
Time frame: 6 months
International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) from baseline to 12 months post treatment
Time frame: 12 months
Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) from baseline to 6 months post treatment
Time frame: 6 months
Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) from baseline to 12 months post treatment
Time frame: 12 months
Patient's Global Impression of Improvement (PGII) at 6 months post treatment
Time frame: 6 months
Patient's Global Impression of Improvement (PGII) at 12 months post treatment
Time frame: 12 months
Pain visual analogue scale
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Derived from this study: PubMed 41221700Phillips C, Shah G, Gamper M, Kuszka A, Chandrakumaran K, Viereck V. Vaginal Erbium Laser for the Treatment of Mild-to-Moderate Stress Urinary Incontinence: A Multicentre Randomised Sham-Controlled Trial. BJOG. 2026 Mar;133(4):609-617. doi: 10.1111/1471-0528.70080. Epub 2025 Nov 12.
- Derived from this study: PubMed 40709601Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Phillips principal investigator
Hampshire Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser therapy in people with Female Stress Incontinence, run by Hampshire Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of 1hr pad weight test (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03996070, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.