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Stress Urinary IncontinenceNCT04348994

Long-term Effectiveness of Non-ablative Er: YAG Laser for Treatment of Stress Urinary Incontinence (SUI)

A study testing Non-ablative thermal-only Er:YAG laser therapy in people with Stress Urinary Incontinence, run by Adrian Gaspar.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Study is designed to assess the long-term clinical effects and safety profile of non-ablative Er:YAG (IncontiLase®) laser treatment, the durability of the results and the optimal treatment regimen for mild-to-severe stages of genuine female stress urinary incontinence (SUI). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Stress Urinary Incontinence
What is being tested?
Non-ablative thermal-only Er:YAG laser therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
No sites listed yet
Study dates
1 Mar 2015to 31 Dec 2018
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 urodynamic study (UDS) diagnosis of Stress Urinary Incontinence
  • 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 III (VLPP > 60 cm H2O)
Show all 15Show fewer
  • Any form of pelvic organ prolapse (POP) stage 2 or greater, 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

About this study

Official title: 3-year Follow up of Patients With Stress Urinary Incontinence Treated With Minimally Invasive Er: YAG Laser

Study is designed to assess the long-term clinical effects and safety profile of non-ablative Er:YAG (IncontiLase®) laser treatment, the durability of the results and the optimal treatment regimen for mild-to-severe stages of genuine female stress urinary incontinence (SUI).

Read the detailed description

All patients with urodynamically proven SUI, who have failed/declined conservative therapies will be informed about the study.

They will be invited to attend a screening/baseline 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 they meet all other inclusion / exclusion criteria, they will be eligible for inclusion. They will receive detailed instructions for performing a 24 hour pad test, and will be asked to keep a 3 day voiding diary. They will be given the International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI SF).

Patients will then undergo 3 outpatient treatment visits. The timing of visits will be approximately 1 month apart. At each of their 3 outpatient appointments, they will be asked about any deleterious effects since their last appointment. Patients will receive 3 treatments in total.

Patients will be invited to attend a follow-up visits 3, 6, 12 and 18 months after the 3rd treatment and asked to complete the 1 hour pad test, 24 hour pad test, 3 day voiding diary and ICIQ-SF questionnaire.

At the 18-, 24- and 30-month follow up, they will be given an option to receive additional single session of non-ablative Er:YAG laser treatment. At each visit, and during additional visit after 36 months, they will be asked to complete all of the tests (1 hour pad test, 24 h hour pad test, 3 day voiding diary and ICIQ-UI SF).

Being tested
Non-ablative thermal-only Er:YAG laser therapy
Keywords
stress urinary incontinence, non-ablative Er:YAG laser
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 thermal-only Er:YAG laser therapyDevice

    Also called IncontiLase®

    Each patient will receive 3 sessions of Er:YAG laser treatment for SUI (IncontiLase®).

    Single-session treatments will be offered to patients after 18, 24 and 30 months following the initial three sessions.

Study groups in NCT04348994
Study groupRoleWhat they receive
Laser therapyExperimentalNon-ablative thermal-only Er:YAG laser treatment using IncontiLase® protocol.
Receives: Device: Non-ablative thermal-only Er:YAG laser therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of ICIQ-UI SF scores

    Change in mean test scores range = 0 - 21; low score = mild symptoms, high score = significant impact on quality of life.

    Measured: Baseline, 3, 6, 12, 18, 24, 30 and 36 months

  2. Assessment of 1 hour pad weight test

    The change in standardised 1 hour pad weight test from baseline to 36 months following treatment schedule.

    Measured: Baseline, 3, 6, 12, 18, 24, 30 and 36 months

Secondary outcomes (2)

  1. Change in 24 hour pad weight test

    The change in standardised 24 hour pad weight test from baseline to 36 months following treatment schedule.

    Measured: Baseline, 3, 6, 12, 18, 24, 30 and 36 months

  2. Change in leakage frequency as assessed by 3 day voiding diary

    The change in leakage frequency from baseline to 36 months following treatment schedule.

    Measured: Baseline, 3, 6, 12, 18, 24, 30 and 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2020
  2. Study start1 Mar 2015
  3. Primary completion1 Sep 2018
  4. Study completion31 Dec 2018

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04348994
Sponsor's protocol ID
SUI/01/2015
Status last verified
Apr 2020
First submitted
14 Apr 2020
Last updated
17 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gaspar A, Koron N, Silva J, Brandi H. Vaginal erbium laser for treatment of stress urinary incontinence: optimization of treatment regimen for a sustained long-term effect. Lasers Med Sci. 2022 Jun;37(4):2157-2164. doi: 10.1007/s10103-021-03474-z. Epub 2022 Jan 24.

    PubMed 35067817

Questions about this trial

What is this clinical trial studying?

A study testing Non-ablative thermal-only Er:YAG laser therapy in people with Stress Urinary Incontinence, run by Adrian Gaspar.

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 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 17 Apr 2020. 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. 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 ICIQ-UI SF scores (time frame: Baseline, 3, 6, 12, 18, 24, 30 and 36 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 NCT04348994, 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 17 Apr 2020.

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