ProlapseVELPOPNCT04523298
Use of Non-ablative Vaginal Erbium YAG Laser for the Treatment of Prolapse
A study testing Non-ablative vaginal Erbium YAG laser treatment and Pelvic floor exercises (PFE) in people with Prolapse, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This is a single center, investigator initiated study, sponsored by the UZ Leuven, Leuven, Belgium; comparing laser treatment to pelvic floor exercises (PFE). Women with symptomatic prolapse (grade II-IV) who seek for a conservative treatment, with no history of previous POP-surgery will be randomised to either the… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prolapse
- What is being tested?
- Non-ablative vaginal Erbium YAG laser treatment and Pelvic floor exercises (PFE)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Nov 2020to 30 Dec 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The presence of POP symptoms
- Diagnosis of cystocele or rectocele of grade II to IV according to the POP-Q system, leading the prolapse (i.e. C ≤ Ba/Bp)
- Voluntary informed consent
Who cannot join
- Symptoms or anatomical evidence for intussusception / rectal prolapse
- Leading descent of the middle compartment (C > Ba/Bp)
- Grade IV prolapse
- Previous POP surgery
- Pregnancy or <12 months postpartum
- Vaginal bleeding, injuries or infection in the treated area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Non-ablative Vaginal Erbium YAG Laser for the Treatment of Prolapse: a Randomized Controlled Clinical Trial
This is a single center, investigator initiated study, sponsored by the UZ Leuven, Leuven, Belgium; comparing laser treatment to pelvic floor exercises (PFE).
Women with symptomatic prolapse (grade II-IV) who seek for a conservative treatment, with no history of previous POP-surgery will be randomised to either the laser-arm or the PFE-arm.
Read more
There are 3 visits where vaginal application of laser will be performed, with a 4-weeks interval. Each application lasts around 15 minutes. The vaginal laser procedure will be performed in an outpatient setting, not requiring any specific preparation, analgesia or anesthesia, by one of two experienced operators.
The primary objective is to evaluate the effects of VEL treatment for reduction of prolapse symptoms and as a secondary outcome objective measurements. These endpoints are in line with the recommendations by Durnea et al., as being the most relevant and patient centered outcomes.
The second goals are to register adverse events and to determine for how long the effects of laser are sustained, with a maximum of two years. To do so, the investigators will measure long term satisfaction with, and the longevity of the effect (measured by the need for repeat or alternative therapy) of laser therapy.
Duration of follow-up per patient: max 27 months
- Conditions
- Prolapse
- Being tested
- Non-ablative vaginal Erbium YAG laser treatment, Pelvic floor exercises (PFE)
- Keywords
- laser, pelvic floor treatment
- Medical subject headings
- Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-ablative vaginal Erbium YAG laser treatmentProcedure or surgery
There are 3 visits where vaginal application of laser will be performed, with a 4-weeks interval. If needed, 3 extra laser applications can be added to the treatment (ie. with a maximum of 6 applications). Each application lasts around 15 minutes. The vaginal laser procedure will be performed in an outpatient setting, not requiring any specific preparation, analgesia or anesthesia, by one of two experienced operators.
Laser therapy is performed using a 2940 nm VEL (SP Spectro, Fotona, Slovenia(24)) with SMOOTH mode setting, which enables non-ablative, thermal-only operation(25). The parameters are selected based on extensive preclinical and clinical studies(26,27,28).
Each laser treatment session consists of a full vaginal canal irradiation (using a 360° circular adapter), followed by additional irradiation of the prolapsed anterior wall (using a 90° angular adaptor) and concluded with irradiation of the vestibule area.
Pelvic floor exercises (PFE)Other
Standard PFE in Belgium are 9 sessions with a pelvic floor physiotherapist of choice, which can be extended by another 9 sessions, if clinically indicated. There are different strategies, though that will be on discretion of the physiotherapist. We will register the type of physiotherapy (standard (PFMT) versus assisted pelvic floor muscles training (APFMT)), number of completed sessions and duration of therapy. What is exactly done by the patient is registered as a variable.
| Study group | Role | What they receive |
|---|---|---|
| Laser | Experimental | Not described Receives: Procedure: Non-ablative vaginal Erbium YAG laser treatment |
| PFE | Active comparator | Not described Receives: Other: Pelvic floor exercises (PFE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome is the subjective improvement of POP symptoms, assessed by the Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6).
Participants have to answer 6 questions concerning POP symptoms with a response scale from 0 to 4 (not present (=0), not at all (=1), somewhat (=2), moderately (=3), quite a bit (=4)). The score (range 0 to 100) is then obtained by multiplying the mean value of all of the answered items by 25. Missing items are dealt with by using the mean from answered items only. Higher scores indicate more distress. This questionnaire is available and validated in English, Dutch and French. Success is defined as a reduction in scores of at least 25% compared with baseline.
Measured: 6 months after last treatment
Secondary outcomes (6)
Assessment of the anatomical success rate by means of the POP-Q system
Anatomical success is defined as POP-Q = grade 0 (no prolapse) or grade I (leading edge < -1cm)
Measured: At every visit (ie. week 4, 8 and 12, optional: 16, 20 and 24 weeks), 6, 12 and 24 months after end of treatment
Assessment of the rate of patient satisfaction by means of the Patient Global Impression of Improvement (PGI)
a 5-point Likert scale (1=much worse, 2=worse, 3=same, 4=better, 5=much better)
Measured: At every visit (ie. week 4, 8 and 12, optional: 16, 20 and 24 weeks), 6, 12 and 24 months after end of treatment
Assessment of the degree of discomfort of the treatment procedure by the patient
VAS-score (Visual Analogue Scale: 0-10cm, continuous scale); the higher the score, the higher the discomfort
Measured: At every visit (ie. week 4, 8 and 12, optional: 16, 20 and 24 weeks), 6, 12 and 24 months after end of treatment
Assessment of the longevity of the effect of laser therapy
Measured by the need for repeating the same, or initiating an alternative therapy
Measured: At every visit (ie. week 4, 8 and 12), end of treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment
Assessment of sexual function, by means of the Pelvic Organ prolapse/Urinary Incontinence Sexual Questionnaire IUGA revised (PISQ-IR)
The PISQ-IR is a questionnaire with twenty questions. Q1 is a question to divide the patients based on sexual activity. Not sexually active (NSA) women are referred to Q2-Q6. Sexually active (SA) women are asked to fill out Q7-Q20. The questionnaire for NSA women consists of five questions or 12 items. A higher score refers to a higher impact of PFD on sexual functioning. The questionnaire for SA women consists of 14 questions wherein women with a partner have to fill out all 14, being 22 items. Women without partner can skip questions 13 and 14, filling out 19 items. A lower score refers to a lower impact of PFD on sexual functioning. This questionnaire is available and validated in English, Dutch and French.
Measured: At every visit (ie. week 4, 8 and 12, optional: 16, 20 and 24 weeks), 6, 12 and 24 months after end of treatment
Assessment of urinary symptoms by means of the Urogenital Distress Inventory (UDI-6)
The final UDI-6 score is calculated by adding all scores as explained in the above, and dividing the result to 6 to obtain a mean value which is in turn multiplied by 25 to obtain the scale score. The score varies from 0 to 100. The basic interpretation of the score is that the higher the score, the higher the disability. This questionnaire is available and validated in English, Dutch and French.
Measured: At every visit (ie. week 4, 8 and 12, optional: 16, 20 and 24 weeks), 6, 12 and 24 months after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start8 Nov 2020
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
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 ProlapseStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prof. dr. Jan Deprest, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523298
- Sponsor's protocol ID
- S64093
- Acronym
- VELPOP
- Status last verified
- May 2024
- First submitted
- 11 Aug 2020
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Page AS, Borowski E, Bauters E, Housmans S, Van der Aa F, Deprest J. Vaginal erbium laser versus pelvic floor exercises for the treatment of pelvic organ prolapse: A randomised controlled trial. Eur J Obstet Gynecol Reprod Biol. 2024 Dec;303:165-170. doi: 10.1016/j.ejogrb.2024.10.042. Epub 2024 Oct 26.
PubMed 39488138
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Non-ablative Vaginal Erbium YAG Laser for the Treatment of Prolapse: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04523298
- Acronym / sponsor ID
- VELPOP / S64093
- Conditions
- Prolapse
- Keywords
- laser, pelvic floor treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 8 Nov 2020 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 21 Aug 2020 (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.
This is a single center, investigator initiated study, sponsored by the UZ Leuven, Leuven, Belgium; comparing laser treatment to pelvic floor exercises (PFE).
Women with symptomatic prolapse (grade II-IV) who seek for a conservative treatment, with no history of previous POP-surgery will be randomised to either the laser-arm or the PFE-arm.
There are 3 visits where vaginal application of laser will be performed, with a 4-weeks interval. Each application lasts around 15 minutes. The vaginal laser procedure will be performed in an outpatient setting, not requiring any specific preparation, analgesia or anesthesia, by one of two experienced operators.
The primary objective is to evaluate the effects of VEL treatment for reduction of prolapse symptoms and as a secondary outcome objective measurements. These endpoints are in line with the recommendations by Durnea et al., as being the most relevant and patient centered outcomes.
The second goals are to register adverse events and to determine for how long the effects of laser are sustained, with a maximum of two years. To do so, the investigators will measure long term satisfaction with, and the longevity of the effect (measured by the need for repeat or alternative therapy) of laser therapy.
Duration of follow-up per patient: max 27 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser | Experimental | Procedure: Non-ablative vaginal Erbium YAG laser treatment |
| PFE | Active comparator | Other: Pelvic floor exercises (PFE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The presence of POP symptoms
- Diagnosis of cystocele or rectocele of grade II to IV according to the POP-Q system, leading the prolapse (i.e. C ≤ Ba/Bp)
- Voluntary informed consent
Key exclusion criteria (6 listed)
- Symptoms or anatomical evidence for intussusception / rectal prolapse
- Leading descent of the middle compartment (C > Ba/Bp)
- Grade IV prolapse
- Previous POP surgery
- Pregnancy or <12 months postpartum
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 |
|---|---|---|
| Non-ablative vaginal Erbium YAG laser treatmentThere are 3 visits where vaginal application of laser will be performed, with a 4-weeks interval. If needed, 3 extra laser applications can be added to the treatment (ie. with a maximum of 6 applications). Each application lasts around 15 minutes. The vaginal laser procedure will be performed in an outpatient setting, not requiring any specific preparation, analgesia or anesthesia, by one of two experienced operators. Laser therapy is performed using a 2940 nm VEL (SP Spectro, Fotona, Slovenia(24)) with SMOOTH mode setting, which enables non-ablative, thermal-only operation(25). The parameters are selected based on extensive preclinical and clinical studies(26,27,28). Each laser treatment session consists of a full vaginal canal irradiation (using a 360° circular adapter), followed by additional irradiation of the prolapsed anterior wall (using a 90° angular adaptor) and concluded with irradiation of the vestibule area. | Procedure or surgery | Laser |
| Pelvic floor exercises (PFE)Standard PFE in Belgium are 9 sessions with a pelvic floor physiotherapist of choice, which can be extended by another 9 sessions, if clinically indicated. There are different strategies, though that will be on discretion of the physiotherapist. We will register the type of physiotherapy (standard (PFMT) versus assisted pelvic floor muscles training (APFMT)), number of completed sessions and duration of therapy. What is exactly done by the patient is registered as a variable. | Other | PFE |
Primary outcome
Primary outcome is the subjective improvement of POP symptoms, assessed by the Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6).
Time frame: 6 months after last treatment
Participants have to answer 6 questions concerning POP symptoms with a response scale from 0 to 4 (not present (=0), not at all (=1), somewhat (=2), moderately (=3), quite a bit (=4)). The score (range 0 to 100) is then obtained by multiplying the mean value of all of the answered items by 25. Missing items are dealt with by using the mean from answered items only. Higher scores indicate more distress. This questionnaire is available and validated in English, Dutch and French. Success is defined as a reduction in scores of at least 25% compared with baseline.
6 secondary outcomes
Assessment of the anatomical success rate by means of the POP-Q system
Time frame: At every visit (ie. week 4, 8 and 12, optional: 16, 20 and 24 weeks), 6, 12 and 24 months after end of treatment
Assessment of the rate of patient satisfaction by means of the Patient Global Impression of Improvement (PGI)
Time frame: At every visit (ie. week 4, 8 and 12, optional: 16, 20 and 24 weeks), 6, 12 and 24 months after end of treatment
Assessment of the degree of discomfort of the treatment procedure by the patient
Time frame: At every visit (ie. week 4, 8 and 12, optional: 16, 20 and 24 weeks), 6, 12 and 24 months after end of treatment
Assessment of the longevity of the effect of laser therapy
Time frame: At every visit (ie. week 4, 8 and 12), end of treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment
Assessment of sexual function, by means of the Pelvic Organ prolapse/Urinary Incontinence Sexual Questionnaire IUGA revised (PISQ-IR)
Time frame: At every visit (ie. week 4, 8 and 12, optional: 16, 20 and 24 weeks), 6, 12 and 24 months after end of treatment
Assessment of urinary symptoms by means of the Urogenital Distress Inventory (UDI-6)
Time frame: At every visit (ie. week 4, 8 and 12, optional: 16, 20 and 24 weeks), 6, 12 and 24 months after end of treatment
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 14 May 2024.
- Derived from this study: PubMed 39488138Page AS, Borowski E, Bauters E, Housmans S, Van der Aa F, Deprest J. Vaginal erbium laser versus pelvic floor exercises for the treatment of pelvic organ prolapse: A randomised controlled trial. Eur J Obstet Gynecol Reprod Biol. 2024 Dec;303:165-170. doi: 10.1016/j.ejogrb.2024.10.042. Epub 2024 Oct 26.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-ablative vaginal Erbium YAG laser treatment and Pelvic floor exercises (PFE) in people with Prolapse, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 6 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 14 May 2024. 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 Belgium. 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. 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?
Primary outcome is the subjective improvement of POP symptoms, assessed by the Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6). (time frame: 6 months after last treatment). 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 NCT04523298, 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 14 May 2024.