VESPER: Pelvic Organ Prolapse Study

NCT ID: NCT03995797

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-01-01

Brief 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. 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.

Conditions

Pelvic Organ Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment arm

Treatment with erbium YAG laser

Group Type: ACTIVE_COMPARATOR

Laser therapy

Intervention Type: PROCEDURE

Erbium YAG laser

Sham arm

Sub therapeutic procedure with erbium YAG laser

Group Type: PLACEBO_COMPARATOR

Laser therapy

Intervention Type: PROCEDURE

Erbium YAG laser

Interventions

Laser therapy

Erbium YAG laser

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Adult Female, 18 years of age or older

2. Clinical diagnosis of symptomatic stage 1-2 pelvic organ prolapse (PoPQ classification)

3. Failed / declined conservative treatments, such as pelvic floor muscle training or vaginal pessaries

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. Any form of pelvic organ prolapse greater than stage 2, according to POP-Q

7. Diagnosis of collagen disorders eg.benign joint hypermobility / Elhers-Danlos / Marfans etc.

8. Incomplete bladder emptying

9. Vesicovaginal fistula

10. Faecal incontinence

11. Unwillingness or inability to complete follow-up schedule

12. Unwillingness or inability to give Informed Consent

13. Failure to comply with diary requirements during extended baseline period

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hampshire Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 40709601 (View on PubMed)

Other Identifiers

2019-FAM-02

Identifier Type: -

Identifier Source: org_study_id