Stress Urinary IncontinenceNCT04636749
Erbium Vaginal Laser for the Treatment of Stress Urinary Incontinence
A study testing Erbium laser in people with Stress Urinary Incontinence, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Two arms of women who suffer from clinical stress urinary incontinence. Women will be divided randomly into two arms. One arm will be treated with vaginal Erbium laser and the second with Sham laser, three treatments each. Follow up will be done 6 and 12 months after the last treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Erbium laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- 9 Mar 2021to 22 Oct 2022
- 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 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women above 18 with SUI -
Who cannot join
- Recurrent pelvic inflammatory disease
- Vaginal operation in the previous year
- Women with abnormal uterine bleeding
- Women with diagnosed genital herpes infection
- Any concurrent lower genital tract infection -
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam Health Care Campus
Haifa
NAAMA FARAGO, DR, +972-4-7772201, N_FARAGO@RMC.GOV.IL
About this study
Official title: Erbium Vaginal Laser for the Treatment of Stress Urinary Incontinence - Randomized Single Blind Trial
Two arms of women who suffer from clinical stress urinary incontinence. Women will be divided randomly into two arms. One arm will be treated with vaginal Erbium laser and the second with Sham laser, three treatments each. Follow up will be done 6 and 12 months after the last treatment.
Read the detailed description
Examine the efficacy of vaginal Erbium laser treatment for stress urinary incontinence (SUI) in compare to placebo.
Plenty of women suffer from SUI. It is a condition in which involuntary urine leakage occurs during exercise. This condition affects about 40% of all women and causes huge disturbance to daily life. There are plenty of risk factors, such as age, obesity and parity. We assume that the pathophysiology is related to hypermobility of the urethra due to damage to the surrounding tissue.
The treatment options vary from surgical interventional to conservative, each treatment has its own success rate and risk factors. An attempt to find effective treatment option has been made.
The use of laser for various gynecologic conditions are at rise. ERBIUM type laser works on the lamina propria layer and causes rejuvenation probably by strengthening collagen structures and creating new ones.
The efficacy and safety of vaginal laser therapy has been proven already, but in the field of SUI the numbers in each study were low and there was no control group.
In this study we desire to examine the effect of vaginal ERBIUM treatment on SUI in compare to placebo.
this is a randomized single blind control trial. 40 women will be included in the research group and 40 in the placebo group. Women will be assigned randomly to each group. They will be treated with vaginal laser probe, three treatments 4 weeks apart. Follow up visits will be performed 3, 6, and 12 months after the first treatment.
Effectiveness evaluation will be done by physical urodynamic examination before treatment and 6 month after finishing, by 24 hours pad test' cough test and by fulfilling questionnaires-
- The Urogenital Distress inventory (UDI6)
- The Female Sexual Function Index (FSFI)
- Conditions
- Stress Urinary Incontinence
- Being tested
- Erbium laser, Sham 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.
Erbium laserDevice
Vaginal laser therapy
Sham laserDevice
Sham laser therapy
| Study group | Role | What they receive |
|---|---|---|
| Erbium laser | Active comparator | Treatment with Erbium laser Receives: Device: Erbium laser |
| Sham laser | Sham comparator | Treatment with sham laser Receives: Device: Sham laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough test
Results of full bladder cough test
Measured: From enrollment up to 12 months post treatment
Pad test
Results of 24 hour pad weighing test
Measured: From enrollment up to 12 months post treatment
Secondary outcomes (3)
Urinary distress index 6
Results of Urinary distress index 6 questionnaire
Measured: From enrollment up to 12 months post treatment
Female sexual function
Results of female sexual function index questionnaire
Measured: From enrollment up to 12 months post treatment
Urinary incontinence and sexuality
Results of urinary incontinence and sexuality questionnaire
Measured: From enrollment up to 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start9 Mar 2021
- Primary completion22 Oct 2022 (estimated)
- Study completion22 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naama Farago MD, Rambam Health Care Campus
- Investigators
- Naama Farago, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636749
- Sponsor's protocol ID
- 0379-20-RMB-CTIL
- Status last verified
- Mar 2021
- First submitted
- 10 Nov 2020
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cervigni M, Gambacciani M. Female urinary stress incontinence. Climacteric. 2015;18 Suppl 1:30-6. doi: 10.3109/13697137.2015.1090859.
PubMed 26366798Padmanabhan P, Dmochowski R. Urinary incontinence in women: a comprehensive review of the pathophysiology, diagnosis and treatment. Minerva Ginecol. 2014 Oct;66(5):469-78. Epub 2014 Jul 31.
PubMed 25078140Itkonen Freitas AM, Rahkola-Soisalo P, Mikkola TS, Mentula M. Current treatments for female primary stress urinary incontinence. Climacteric. 2019 Jun;22(3):263-269. doi: 10.1080/13697137.2019.1568404. Epub 2019 Feb 18.
PubMed 30773062Kobashi KC, Albo ME, Dmochowski RR, Ginsberg DA, Goldman HB, Gomelsky A, Kraus SR, Sandhu JS, Shepler T, Treadwell JR, Vasavada S, Lemack GE. Surgical Treatment of Female Stress Urinary Incontinence: AUA/SUFU Guideline. J Urol. 2017 Oct;198(4):875-883. doi: 10.1016/j.juro.2017.06.061. Epub 2017 Jun 15.
PubMed 28625508Dwyer PL, Karmakar D. Surgical management of urinary stress incontinence - Where are we now? Best Pract Res Clin Obstet Gynaecol. 2019 Jan;54:31-40. doi: 10.1016/j.bpobgyn.2018.10.003. Epub 2018 Oct 30.
PubMed 30503362Saraswat L, Rehman H, Omar MI, Cody JD, Aluko P, Glazener CM. Traditional suburethral sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2020 Jan 28;1(1):CD001754. doi: 10.1002/14651858.CD001754.pub5.
PubMed 31990055Majaron B, Srinivas SM, Huang He, Nelson JS. Deep coagulation of dermal collagen with repetitive Er:YAG laser irradiation. Lasers Surg Med. 2000;26(2):215-22. doi: 10.1002/(sici)1096-9101(2000)26:23.0.co;2-o.
PubMed 10685095Greene D, Egbert BM, Utley DS, Koch RJ. In vivo model of histologic changes after treatment with the superpulsed CO(2) laser, erbium:YAG laser, and blended lasers: a 4- to 6-month prospective histologic and clinical study. Lasers Surg Med. 2000;27(4):362-72. doi: 10.1002/1096-9101(2000)27:43.0.co;2-h.
PubMed 11074514Vizintin Z, Lukac M, Kazic M, Tettamanti M. Erbium laser in gynecology. Climacteric. 2015;18 Suppl 1:4-8. doi: 10.3109/13697137.2015.1078668.
PubMed 26366793Okui N. Efficacy and safety of non-ablative vaginal erbium:YAG laser treatment as a novel surgical treatment for overactive bladder syndrome: comparison with anticholinergics and beta3-adrenoceptor agonists. World J Urol. 2019 Nov;37(11):2459-2466. doi: 10.1007/s00345-019-02644-7. Epub 2019 Jan 28.
PubMed 30687908Pergialiotis V, Prodromidou A, Perrea DN, Doumouchtsis SK. A systematic review on vaginal laser therapy for treating stress urinary incontinence: Do we have enough evidence? Int Urogynecol J. 2017 Oct;28(10):1445-1451. doi: 10.1007/s00192-017-3437-x. Epub 2017 Aug 2.
PubMed 28770296Shobeiri SA, Kerkhof MH, Minassian VA, Bazi T; IUGA Research and Development Committee. IUGA committee opinion: laser-based vaginal devices for treatment of stress urinary incontinence, genitourinary syndrome of menopause, and vaginal laxity. Int Urogynecol J. 2019 Mar;30(3):371-376. doi: 10.1007/s00192-018-3830-0. Epub 2018 Dec 6.
PubMed 30523374Fistonic I, Fistonic N. Baseline ICIQ-UI score, body mass index, age, average birth weight, and perineometry duration as promising predictors of the short-term efficacy of Er:YAG laser treatment in stress urinary incontinent women: A prospective cohort study. Lasers Surg Med. 2018 Jan 23. doi: 10.1002/lsm.22789. Online ahead of print.
PubMed 29360142Su CF, Chen GD, Tsai HJ. Preliminary outcome of non-ablative vaginal Erbium laser treatment for female stress and mixed urinary incontinence. Taiwan J Obstet Gynecol. 2019 Sep;58(5):610-613. doi: 10.1016/j.tjog.2019.07.006.
PubMed 31542080Ogrinc UB, Sencar S, Lenasi H. Novel minimally invasive laser treatment of urinary incontinence in women. Lasers Surg Med. 2015 Nov;47(9):689-97. doi: 10.1002/lsm.22416. Epub 2015 Sep 21.
PubMed 26388213
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erbium Vaginal Laser for the Treatment of Stress Urinary Incontinence - Randomized Single Blind Trial
- ClinicalTrials.gov ID
- NCT04636749
- Acronym / sponsor ID
- 0379-20-RMB-CTIL
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 22 Oct 2022 (estimated)
- Study completion
- 22 Oct 2022 (estimated)
- First posted
- 19 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.
Two arms of women who suffer from clinical stress urinary incontinence. Women will be divided randomly into two arms. One arm will be treated with vaginal Erbium laser and the second with Sham laser, three treatments each. Follow up will be done 6 and 12 months after the last treatment.
Detailed description
Examine the efficacy of vaginal Erbium laser treatment for stress urinary incontinence (SUI) in compare to placebo.
Plenty of women suffer from SUI. It is a condition in which involuntary urine leakage occurs during exercise. This condition affects about 40% of all women and causes huge disturbance to daily life. There are plenty of risk factors, such as age, obesity and parity. We assume that the pathophysiology is related to hypermobility of the urethra due to damage to the surrounding tissue.
The treatment options vary from surgical interventional to conservative, each treatment has its own success rate and risk factors. An attempt to find effective treatment option has been made.
The use of laser for various gynecologic conditions are at rise. ERBIUM type laser works on the lamina propria layer and causes rejuvenation probably by strengthening collagen structures and creating new ones.
The efficacy and safety of vaginal laser therapy has been proven already, but in the field of SUI the numbers in each study were low and there was no control group.
In this study we desire to examine the effect of vaginal ERBIUM treatment on SUI in compare to placebo.
this is a randomized single blind control trial. 40 women will be included in the research group and 40 in the placebo group. Women will be assigned randomly to each group. They will be treated with vaginal laser probe, three treatments 4 weeks apart. Follow up visits will be performed 3, 6, and 12 months after the first treatment.
Effectiveness evaluation will be done by physical urodynamic examination before treatment and 6 month after finishing, by 24 hours pad test' cough test and by fulfilling questionnaires-
- The Urogenital Distress inventory (UDI6)
- The Female Sexual Function Index (FSFI)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erbium laser | Active comparator | Device: Erbium laserTreatment with Erbium laser |
| Sham laser | Sham comparator | Device: Sham laserTreatment with sham laser |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women above 18 with SUI -
Key exclusion criteria (5 listed)
- Recurrent pelvic inflammatory disease
- Vaginal operation in the previous year
- Women with abnormal uterine bleeding
- Women with diagnosed genital herpes infection
- Any concurrent lower genital tract infection -
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 |
|---|---|---|
| Erbium laserVaginal laser therapy | Device | Erbium laser |
| Sham laserSham laser therapy | Device | Sham laser |
Primary outcome
Cough test
Time frame: From enrollment up to 12 months post treatment
Results of full bladder cough test
Pad test
Time frame: From enrollment up to 12 months post treatment
Results of 24 hour pad weighing test
3 secondary outcomes
Urinary distress index 6
Time frame: From enrollment up to 12 months post treatment
Female sexual function
Time frame: From enrollment up to 12 months post treatment
Urinary incontinence and sexuality
Time frame: From enrollment up to 12 months post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Background: PubMed 26366798Cervigni M, Gambacciani M. Female urinary stress incontinence. Climacteric. 2015;18 Suppl 1:30-6. doi: 10.3109/13697137.2015.1090859.
- Background: PubMed 25078140Padmanabhan P, Dmochowski R. Urinary incontinence in women: a comprehensive review of the pathophysiology, diagnosis and treatment. Minerva Ginecol. 2014 Oct;66(5):469-78. Epub 2014 Jul 31.
- Background: PubMed 30773062Itkonen Freitas AM, Rahkola-Soisalo P, Mikkola TS, Mentula M. Current treatments for female primary stress urinary incontinence. Climacteric. 2019 Jun;22(3):263-269. doi: 10.1080/13697137.2019.1568404. Epub 2019 Feb 18.
- Background: PubMed 28625508Kobashi KC, Albo ME, Dmochowski RR, Ginsberg DA, Goldman HB, Gomelsky A, Kraus SR, Sandhu JS, Shepler T, Treadwell JR, Vasavada S, Lemack GE. Surgical Treatment of Female Stress Urinary Incontinence: AUA/SUFU Guideline. J Urol. 2017 Oct;198(4):875-883. doi: 10.1016/j.juro.2017.06.061. Epub 2017 Jun 15.
- Background: PubMed 30503362Dwyer PL, Karmakar D. Surgical management of urinary stress incontinence - Where are we now? Best Pract Res Clin Obstet Gynaecol. 2019 Jan;54:31-40. doi: 10.1016/j.bpobgyn.2018.10.003. Epub 2018 Oct 30.
- Background: PubMed 31990055Saraswat L, Rehman H, Omar MI, Cody JD, Aluko P, Glazener CM. Traditional suburethral sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2020 Jan 28;1(1):CD001754. doi: 10.1002/14651858.CD001754.pub5.
- Background: PubMed 10685095Majaron B, Srinivas SM, Huang He, Nelson JS. Deep coagulation of dermal collagen with repetitive Er:YAG laser irradiation. Lasers Surg Med. 2000;26(2):215-22. doi: 10.1002/(sici)1096-9101(2000)26:23.0.co;2-o.
- Background: PubMed 11074514Greene D, Egbert BM, Utley DS, Koch RJ. In vivo model of histologic changes after treatment with the superpulsed CO(2) laser, erbium:YAG laser, and blended lasers: a 4- to 6-month prospective histologic and clinical study. Lasers Surg Med. 2000;27(4):362-72. doi: 10.1002/1096-9101(2000)27:43.0.co;2-h.
- Background: PubMed 26366793Vizintin Z, Lukac M, Kazic M, Tettamanti M. Erbium laser in gynecology. Climacteric. 2015;18 Suppl 1:4-8. doi: 10.3109/13697137.2015.1078668.
- Background: PubMed 30687908Okui N. Efficacy and safety of non-ablative vaginal erbium:YAG laser treatment as a novel surgical treatment for overactive bladder syndrome: comparison with anticholinergics and beta3-adrenoceptor agonists. World J Urol. 2019 Nov;37(11):2459-2466. doi: 10.1007/s00345-019-02644-7. Epub 2019 Jan 28.
- Background: PubMed 28770296Pergialiotis V, Prodromidou A, Perrea DN, Doumouchtsis SK. A systematic review on vaginal laser therapy for treating stress urinary incontinence: Do we have enough evidence? Int Urogynecol J. 2017 Oct;28(10):1445-1451. doi: 10.1007/s00192-017-3437-x. Epub 2017 Aug 2.
- Background: PubMed 30523374Shobeiri SA, Kerkhof MH, Minassian VA, Bazi T; IUGA Research and Development Committee. IUGA committee opinion: laser-based vaginal devices for treatment of stress urinary incontinence, genitourinary syndrome of menopause, and vaginal laxity. Int Urogynecol J. 2019 Mar;30(3):371-376. doi: 10.1007/s00192-018-3830-0. Epub 2018 Dec 6.
- 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.
Naama Farago, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erbium laser in people with Stress Urinary Incontinence, run by Rambam Health Care Campus at 1 site in Israel.
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 1 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: status not confirmed, as of the sponsor's last update on 10 Mar 2021. 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 Israel. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naama Farago, MD (972-509267806, n_farago@rmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cough test (time frame: From enrollment up to 12 months post treatment). 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 NCT04636749, which also lists 20 linked publications.
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 10 Mar 2021.