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Stress Urinary IncontinenceNCT03296241

Non-ablative Er:Yttrium Aluminum Garnet Laser for Stress Urinary Incontinence (SUI)

A study testing laser in people with Stress Urinary Incontinence, run by Dr Adolf Lukanovič.

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

Stress urinary incontinence (SUI) is a common complaint in women after childbirth. The aim of this study was to evaluate the efficacy and safety of non-ablative Er:YAG laser therapy in the treatment of SUI and improvement of sexual gratification in parous women. Read more about this study

Who is it for?
Ages 35 to 65 years, women only
Conditions the study is for
Stress Urinary Incontinence
What is being tested?
laser
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
114 participants
Where
No sites listed yet
Study dates
1 Aug 2012to 30 Aug 2013
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 35 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • diagnosis of stress urinary incontinence
  • sexually active
  • at least one vaginal delivery

Who cannot join

  • pelvic organ prolapse greater than stage I
  • urgency or mixed UI
  • infection
  • previous gynaecologic surgery or irradiation
  • refuse consent

About this study

Official title: Non-ablative Er:Yttrium Aluminum Garnet (Er:YAG) Laser Therapy Effect on Stress Urinary Incontinence (SUI) Related Quality of Life and Sexual Function: a Randomized Controlled Trial

Stress urinary incontinence (SUI) is a common complaint in women after childbirth. The aim of this study was to evaluate the efficacy and safety of non-ablative Er:YAG laser therapy in the treatment of SUI and improvement of sexual gratification in parous women. 114 premenopausal parous women with SUI were randomized in two groups of 57 women; a laser intervention group and sham control (placebo) group. Both groups were treated according to the IncontiLaseTM clinical treatment protocol for SUI with non-ablative thermal-only Er:YAG laser, except that there was no energy output when treating the sham group. Patients were blinded to the allocation. At baseline and 3 months after treatment patients were clinically examined, answered questionnaires for SUI severity sexual function assessment and their pelvic floor muscle (PFM) function was assessed with perineometry. The improvement in the laser group will be compared to the improvement in the sham group.

Read the detailed description

Stress urinary incontinence (SUI) is a common complaint in women after childbirth. It affects their quality of life and sexual satisfaction and is one of the major reasons for gynaecological surgery. There is a need for effective non-invasive treatment alternatives. The aim of this study was to evaluate the efficacy and safety of non-ablative Er:YAG laser therapy in the treatment of SUI and improvement of sexual gratification in parous women. 114 premenopausal parous women with SUI were randomized in two groups of 57 women; a laser intervention group and sham control (placebo) group. Both groups were treated according to the IncontiLaseTM clinical treatment protocol for SUI with non-ablative thermal-only Er:YAG laser, except that there was no energy output when treating the sham group. Patients were blinded to the allocation. At baseline and 3 months after treatment patients were clinically examined, answered questionnaires for SUI severity sexual function assessment and their pelvic floor muscle (PFM) function was assessed with perineometry. Validated International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) was used as the primary outcome measure. The Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire short form (PISQ-12) and The Female Sexual Function Index (FSFI) were used to assess the sexual function. Patients were monitored for discomfort and side-effects during treatment and follow up period.

Being tested
laser, sham control
Keywords
stress urinary incontinence, sexual dysfunction, laser, Er:YAG, vaginal laser, vaginal tightening, non-ablative, minimally-invasive
Medical subject headings
Urinary Incontinence, Stress, Sexual Dysfunction, Physiological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • laserDevice

    Also called IncontiLaseTM, IncontiLase

  • sham controlDevice

    Also called placebo

Study groups in NCT03296241
Study groupRoleWhat they receive
LaserExperimentalOne session of non-ablative Er:YAG laser (2940 nm) treatment of the vaginal wall, introitus and vestibule.
Receives: Device: laser
Sham controlSham comparatorThe sham control group was treated with the same procedure but with zero intensity settings - without receiving therapeutic irradiation (placebo).
Receives: Device: sham control

What is being measured

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

  1. Change from baseline in ICIQ-UI SF score

    International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form

    Measured: at 3 months after intervention

Secondary outcomes (5)

  1. Change from baseline in PISQ-12 score

    The Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire

    Measured: at 3 months after intervention

  2. Change from baseline in FSFI score

    The Female Sexual Function Index, a validated generalized questionnaire utilized to assess sexual function in women in a general population.

    Measured: at 3 months after intervention

  3. Change from baseline in perineometry variable maximal contraction pressure

    Measured with Myomed 632 perineometer with the women in supine position.

    Measured: at 3 months after intervention

  4. Change from baseline in perineometry variable average contraction pressure

    Measured with Myomed 632 perineometer with the women in supine position.

    Measured: at 3 months after intervention

  5. Change from baseline in perineometry variable mean muscle endurance (stamina)

    Measured with Myomed 632 perineometer with the women in supine position.

    Measured: at 3 months after intervention

Timeline

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

  1. First posted28 Sep 2017
  2. Study start1 Aug 2012
  3. Primary completion30 Aug 2013
  4. Study completion30 Aug 2013

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
Randomised
Intervention model
Parallel groups
Model description
Patients assigned randomly to two groups: laser-treatment group and sham (control) group
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03296241
Sponsor's protocol ID
SUI_ErYAG_Sham
Status last verified
Sep 2017
First submitted
21 Sep 2017
Last updated
28 Sep 2017
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

Questions about this trial

What is this clinical trial studying?

A study testing laser in people with Stress Urinary Incontinence, run by Dr Adolf Lukanovič.

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 5 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 28 Sep 2017. 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 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?

Change from baseline in ICIQ-UI SF score (time frame: at 3 months after intervention). 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 NCT03296241, 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 28 Sep 2017.

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