Pelvic Organ ProlapseVESPER:POPNCT03995797
VESPER: Pelvic Organ Prolapse Study
A study testing Laser therapy in people with Pelvic Organ Prolapse, run by Hampshire Hospitals NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 1 Jan 2023
- 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 diagnosis of symptomatic stage 1-2 pelvic organ prolapse (PoPQ classification)
- Failed / declined conservative treatments, such as pelvic floor muscle training or vaginal pessaries
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
- Any form of pelvic organ prolapse greater than stage 2, according to POP-Q
Show all 13Show fewer
- 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
About this study
Official title: Randomised, Sham Controlled Trial of Fotona Smooth Erbium Yag Laser In the Treatment of Pelvic Organ Prolapse.
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.
Read the 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.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Laser therapy
- Medical subject headings
- Pelvic Organ Prolapse
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 | Treatment with erbium YAG laser Receives: Procedure: Laser therapy |
| Sham arm | Placebo comparator | Sub therapeutic procedure with erbium YAG laser Receives: Procedure: Laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Organ Prolapse Quantification Score (POP-Q) between baseline and 6 months after treatment.
The change in Pelvic Organ Prolapse Quantification Score (PoP-Q)classification between baseline and 6 months, range = 0 - stage 4
Measured: 6 months
Pelvic Organ Prolapse Quantification Score (POP-Q) between baseline and 12 months after treatment.
The change in Pelvic Organ Prolapse Quantification Score (PoP-Q) classification between baseline and 12 months, range = 0 - stage 4
Measured: 12 months
Secondary outcomes (7)
Change in mean International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS) test scores from baseline to 6 months post treatment
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.
Measured: 6 months
Change in mean International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS) test scores from baseline to 12 months post treatment
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.
Measured: 12 months
Patient's Global Impression of Improvement (PGI-I) at 6 months
Questionnaire scores - range 1 (very much worse) to 7 (very much improved)
Measured: 6 months
Patient's Global Impression of Improvement (PGI-I) at 12 months
Questionnaire scores - range 1 (very much worse) to 7 (very much improved)
Measured: 12 months
Change in mean Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) scores
Change in mean test scores - range = 0 - 48; Higher value = increased sexual function, lower value = less sexual function
Measured: 6 months
Change in mean Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) scores
Change in mean test scores - range = 0 - 48; Higher value = increased sexual function, lower value = less sexual function
Measured: 12 months
Pain visual analogue scale
Patient reported assessment of pain on 10cm visual analogue scale during treatment, range 1 - 10cm; 0= no pain, 10= severe pain
Measured: 4 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 start1 Jan 2023
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Why it stopped: Study did not open
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hampshire Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995797
- Sponsor's protocol ID
- 2019-FAM-02
- Acronym
- VESPER:POP
- Status last verified
- Sep 2025
- First submitted
- 28 Mar 2019
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ippolito 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 23 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 Pelvic Organ Prolapse.
- ClinicalTrials.gov ID
- NCT03995797
- Acronym / sponsor ID
- VESPER:POP / 2019-FAM-02
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study did not open
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hampshire Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (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 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.
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 therapyTreatment with erbium YAG laser |
| Sham arm | Placebo comparator | Procedure: Laser therapySub therapeutic procedure with erbium YAG laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 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
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
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
7 secondary outcomes
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 International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS) test scores from baseline to 12 months post treatment
Time frame: 12 months
Patient's Global Impression of Improvement (PGI-I) at 6 months
Time frame: 6 months
Patient's Global Impression of Improvement (PGI-I) at 12 months
Time frame: 12 months
Change in mean Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) scores
Time frame: 6 months
Change in mean Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) scores
Time frame: 12 months
Pain visual analogue scale
Time frame: 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Laser therapy in people with Pelvic Organ Prolapse, run by Hampshire Hospitals NHS Foundation Trust.
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 3 inclusion and 13 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: withdrawn, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Pelvic Organ Prolapse Quantification Score (POP-Q) between baseline and 6 months after treatment. (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT03995797, which also lists 1 linked publication.
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 23 Sep 2025.