Urinary Incontinence,StressVELSUINCT04643353
Use of Non-ablative Vaginal Erbium YAG Laser for the Treatment of Stress Urinary Incontinence.
A study testing Non-ablative vaginal Erbium YAG laser treatment and PFE in people with Urinary Incontinence,Stress, 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 stress urinary incontinence who seek for a conservative treatment, with no history of previous incontinence-surgery will be randomised to… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Urinary Incontinence,Stress
- What is being tested?
- Non-ablative vaginal Erbium YAG laser treatment and PFE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 27 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The presence of mild (score 1-2) to moderate (3-6) SUI with wish for treatment. The patient can have concomitant urge urinary incontinence (UUI), but that should not be the leading factor. Incontinence severity will be categorized by the four-level Sandvik severity index score (SIS). Scores are from 0 to 12. The higher the score, the more severe the urinary incontinence (mild=1-2, moderate= 3-6, severe=8-9, very severe=12).
- Voluntary informed consent
Who cannot join
- Any previous PFE-treatment in the last year for the same problem
- Previous surgery for incontinence or prolapse
- Severe (Sandvik SIS ≥8) SUI or insensible loss, high suspicion of intrinsic sphincter deficiency (ISD)
- Prolapse grade III or more
- Pregnancy
- Vaginal bleeding, injuries or infection in the treated area
Trial locations and contacts
1 site in 1 country.
About this study
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 stress urinary incontinence who seek for a conservative treatment, with no history of previous incontinence-surgery will be randomised to either the laser-arm or the PFE-arm.
Read more
There are 3 visits (with a maximum of 6 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 the subjective cure or improvement of SUI.
The secondary objectives are to measure objective outcomes, to register any adverse events, and to determine for how long the effects of laser are sustained, with a maximum of two years.
- Conditions
- Urinary Incontinence,Stress
- Being tested
- Non-ablative vaginal Erbium YAG laser treatment, PFE
- Medical subject headings
- Urinary Incontinence, Stress
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 treatmentDevice
Laser therapy is performed using a 2940 nm VEL (SP Spectro, Fotona, Slovenia) with SMOOTH mode setting, which enables non-ablative, thermal-only operation. The parameters are selected based on extensive preclinical and clinical studies.
PFEOther
PFE will be prescribed as it is already implemented in clinical practice (i.e. up to 2x 9 sessions with a pelvic floor physiotherapist of choice). Type of physiotherapy, number of completed sessions and duration of therapy will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Non-ablative vaginal Erbium YAG laser treatment | Experimental | 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)with SMOOTH mode setting, which enables non-ablative, thermal-only operation). The parameters are selected based on extensive preclinical and clinical studies.
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. Receives: Device: Non-ablative vaginal Erbium YAG laser treatment |
| Pelvic floor exercises (PFE) | Active comparator | 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. Receives: Other: PFE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome is the subjective success rate (cure or improvement) of SUI
The tool used is the UDI-6 questionnaire. Converted UDI-6 scores range between 0 and 300. The "minimum important difference" is defined as a (MID)=11. In that score, cure is defined as answering "No" (0) to the question "Do you experience urine leakage related to physical activity, coughing or sneezing?".
Measured: 4 months after randomisation
Secondary outcomes (7)
Assessment of overall urinary symptoms by means of the Urogenital Distress Inventory (UDI-6).
The final UDI-6 score is calculated by adding all scores, 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), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment
Assessment of the objective success rate by means of the cough stress test (CST).
A working group of the International Continence Society (ICS) has developed instructions on the performance, interpretation and reporting of the CST in a standardized manner: the ICS-Uniform Cough Stress Test (ICS-UCST).
For the ICS-UCST it is recommended that the patient is in a supine/lithotomy position with 200-400 mL of fluid in the bladder, which can be non-invasively assessed with a bladder scan. She coughs forcefully 1-4 times and the examiner directly visualizes the urethral meatus for the presence of leakage. Leakage of fluid from the urethral meatus coincident with/ simultaneous to the cough(s) is considered a positive test. If the test is negative (i.e, no leakage detected), then accessory stress testing such as repeating the test in the upright position should be considered.
Measured: At every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 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)
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), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment
Assessment of the degree of discomfort of the treatment procedure by the patient
VAS-score (0-10cm, continuous scale)
Measured: At every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment
Assessment of the longevity of the effect of laser therapy
measured by the need for, and the timing for repeating the same, or initiating an alternative therapy.
Measured: At every visit (ie. week 4, 8 and 12), end of initial 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 dividing question on being sexually active or not. 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 the 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 the 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), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment
Assessment of treatment compliance in the PFE-group
Therefore we will monitor how many of the participants attended the PFE treatment complete all sessions with their physical therapist.
Measured: At end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatmentAt every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start27 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.
- Other trials for Urinary Incontinence,StressStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 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
- Investigators
- Jan Deprest, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643353
- Sponsor's protocol ID
- S64486
- Acronym
- VELSUI
- Status last verified
- May 2024
- First submitted
- 18 Nov 2020
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 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 Stress Urinary Incontinence.
- ClinicalTrials.gov ID
- NCT04643353
- Acronym / sponsor ID
- VELSUI / S64486
- Conditions
- Urinary Incontinence,Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 27 Nov 2020 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 25 Nov 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 stress urinary incontinence who seek for a conservative treatment, with no history of previous incontinence-surgery will be randomised to either the laser-arm or the PFE-arm.
There are 3 visits (with a maximum of 6 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 the subjective cure or improvement of SUI.
The secondary objectives are to measure objective outcomes, to register any adverse events, and to determine for how long the effects of laser are sustained, with a maximum of two years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-ablative vaginal Erbium YAG laser treatment | Experimental | Device: 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)with SMOOTH mode setting, which enables non-ablative, thermal-only operation). The parameters are selected based on extensive preclinical and clinical studies. 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) | Active comparator | Other: PFEStandard 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- The presence of mild (score 1-2) to moderate (3-6) SUI with wish for treatment. The patient can have concomitant urge urinary incontinence (UUI), but that should not be the leading factor. Incontinence severity will be categorized by the four-level Sandvik severity index score (SIS). Scores are from 0 to 12. The higher the score, the more severe the urinary incontinence (mild=1-2, moderate= 3-6, severe=8-9, very severe=12).
- Voluntary informed consent
Key exclusion criteria (6 listed)
- Any previous PFE-treatment in the last year for the same problem
- Previous surgery for incontinence or prolapse
- Severe (Sandvik SIS ≥8) SUI or insensible loss, high suspicion of intrinsic sphincter deficiency (ISD)
- Prolapse grade III or more
- Pregnancy
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 treatmentLaser therapy is performed using a 2940 nm VEL (SP Spectro, Fotona, Slovenia) with SMOOTH mode setting, which enables non-ablative, thermal-only operation. The parameters are selected based on extensive preclinical and clinical studies. | Device | Non-ablative vaginal Erbium YAG laser treatment |
| PFEPFE will be prescribed as it is already implemented in clinical practice (i.e. up to 2x 9 sessions with a pelvic floor physiotherapist of choice). Type of physiotherapy, number of completed sessions and duration of therapy will be recorded. | Other | Pelvic floor exercises (PFE) |
Primary outcome
Primary outcome is the subjective success rate (cure or improvement) of SUI
Time frame: 4 months after randomisation
The tool used is the UDI-6 questionnaire. Converted UDI-6 scores range between 0 and 300. The "minimum important difference" is defined as a (MID)=11. In that score, cure is defined as answering "No" (0) to the question "Do you experience urine leakage related to physical activity, coughing or sneezing?".
7 secondary outcomes
Assessment of overall urinary symptoms by means of the Urogenital Distress Inventory (UDI-6).
Time frame: At every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment
Assessment of the objective success rate by means of the cough stress test (CST).
Time frame: At every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 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), end of initial treatment (ie. 4 months after randomisation), 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), end of initial treatment (ie. 4 months after randomisation), 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 initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment
Assessment of sexual function
Time frame: At every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment
Assessment of treatment compliance in the PFE-group
Time frame: At end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatmentAt every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24
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 26 Sep 2024.
- 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.
Jan Deprest, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
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 PFE in people with Urinary Incontinence,Stress, 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 2 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 26 Sep 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 success rate (cure or improvement) of SUI (time frame: 4 months after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2024.