Stress Urinary IncontinenceNCT03676894
Intraurethral/Intravaginal 2940 Nm Erbium Laser Treatment for Stress Urinary Incontinence
A study testing Intravaginal Fotona SP Dynamis and Intraurethral Fotona SP Dynamis in people with Stress Urinary Incontinence, run by Fotona d.o.o. at 2 sites in Canada.
Trial summary
Primary objective is to assess the tolerability and safety of the intraurethral 2940nm Er:YAG laser technique in combination with intravaginal 2940nm Er:YAG laser method for the treatment of stress urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Intravaginal Fotona SP Dynamis and Intraurethral Fotona SP Dynamis
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 2 sitesCanada
- Study dates
- 4 Jun 2018to 23 May 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female between 18 and 80 years
- SUI or MUI with predominantly stress symptoms for more than 6 months
- Has failed 2 previous non-invasive therapies for three (3) months each (e.g. behavioural modification, electrical stimulation, pelvic muscle exercise, biofeedback, and/or drug therapy)
- Confirmed SUI through cough stress test or urodynamics
- Has at least one incontinence episode per 24 hour period measured over three days
- Valsalva leak-point pressure (VLPP) ≤100 cm H2O
Show all 10Show fewer
- Has a baseline 24h pad weight test ≥ 10 gm
- Has maximum cystometric capacity ≥250 mL
- No pelvic surgery within last 6 months (including prolapse repair, subjects who have residual or recurrent SUI following colposuspension or a sling procedure may be included in the study if the procedure was conducted at least 6 months prior to screening /baseline visit)
- Willing to give informed consent and complete the follow up schedule
Who cannot join
- Active urinary tract or vaginal infection or other active infections of urinary tract or bladder (urethritis, cystitis or vaginitis)
- Has had three (3) or more cultured-proven bacterial urinary tract infection (UTI) in the last 12 months
- Clinical diagnosis of urge incontinence or urge predominant mixed incontinence
- Has detrusor overactivity on urodynamics
- postvoiding residual (PVR) > 100 ml
- Has had previous urethral surgery (i.e. fistula or diverticula)
Show all 19Show fewer
- Grade 2 or higher Pelvic organ prolapse (POP) or Pelvic organ prolapse grade > 2 as defined by POP-Q and symptomatic
- Suffers from known polyuria (>3l/24h)
- Has a BMI ≤35 kg/m2
- Has unevaluated hematuria
- Has a neurogenic bladder
- Evidence of dysplasia in a Pap smear (done in the last 24 months)
- Tumours of the Urinary tract
- Previous radiation or brachytherapy to treat pelvic cancer
- Has uncontrolled diabetes
- Has active herpes genitalis
- Pregnancy, lactating, or not practicing adequate contraception and/or planning to get pregnant in the next 12 months
- Had a vaginal delivery within 6 months prior to the Screening/Baseline Visit
- Is currently participating in any other clinical trial, or has participated in another clinical trial within 3 months prior to the Screening/Baseline Visit
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Exgogenia, Institute of Anti-Aging and Regenerative Medicine
Sherbrooke, Quebec, J1L 1C6
University Urology Associates
Toronto, Ontario, M5T 2S8
About this study
Official title: Pilot Single-masked, Randomized, 3-arm Parallel Study Assessing the Tolerability, Safety and Efficacy of Intraurethral/Intravaginal 2940 Nm Er:YAG Laser Treatment for Stress Urinary Incontinence
Primary objective is to assess the tolerability and safety of the intraurethral 2940nm Er:YAG laser technique in combination with intravaginal 2940nm Er:YAG laser method for the treatment of stress urinary incontinence.
Read the detailed description
This study is a prospective, randomized, 3-arm parallel pilot study. Study subjects will be women currently experiencing female stress urinary incontinence (SUI) and stress-predominant mixed urinary incontinence (SMUI) with a degree of intrinsic sphincter deficiency for a minimum duration of 6 months prior to enrolment. Diagnosis of SUI with a degree of intrinsic sphincter deficiency will be performed using urodynamic and clinical assessment.
Subjects will undergo sham, intravaginal, and the combination of intravaginal and intraurethral treatment with the 2940 nm Er:yttrium aluminum garnet Er:YAG laser at two time points, 4 weeks apart. Primary objective is to assess the tolerability and safety of the intraurethral 2940nm Er:YAG laser technique in combination with intravaginal 2940nm Er:YAG laser method for the treatment of stress urinary incontinence through 6 months follow-up and extend to 12 months follow-up.
Secondary objective is to assess the effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments using subjective and objective measures, as well as improvement in quality of life through 6 months follow-up and extend to 12 months follow-up.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Sham Fotona SP Dynamis, Intravaginal Fotona SP Dynamis, Intraurethral Fotona SP Dynamis
- 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.
Sham Fotona SP DynamisDevice
Female patients with SUI will be treated with non-ablative Er:YAG laser with Fotona SP Dynamis with sham handpiece.
Intravaginal Fotona SP DynamisDevice
Female patients with SUI will be treated intravaginaly with non-ablative Er:YAG laser with Fotona SP Dynamis
Intraurethral Fotona SP DynamisDevice
Female patients with SUI will be treated intraurethraly with non-ablative Er:YAG laser with Fotona SP Dynamis
| Study group | Role | What they receive |
|---|---|---|
| Sham Treatment | Sham comparator | Sham Fotona SP Dynamis Treatment - minimum energy delivered through sham handpiece. Receives: Device: Sham Fotona SP Dynamis |
| Intravaginal Treatment | Active comparator | Intravaginal Fotona SP Dynamis Treatment - energy delivered intravaginally. Receives: Device: Intravaginal Fotona SP Dynamis |
| Intravaginal and intraurethral Treatment | Experimental | Intravaginal and intraurethral Fotona SP Dynamis Treatment Intravaginal Treatment - energy delivered intravaginally and intraurethrally. Receives: Device: Intravaginal Fotona SP Dynamis; Device: Intraurethral Fotona SP Dynamis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability of the 2940nm Er:YAG laser technique by VAS pain scale
The tolerability of intra-urethral/intravaginal Er:YAG laser treatment by VAS pain scale during procedure and by monitoring the use of pain relieving medication post treatment. The Visual Analog Scale for Pain (VAS) is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations.
Measured: 18 months
The Safety of intra-urethral/intravaginal Er:YAG laser procedure by recording the incidence and severity of complications
The Safety of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women, as assessed by recording the incidence and severity of complications
Measured: 18 months
The Safety of intra-urethral/intravaginal Er:YAG laser procedure by recording the incidence of device related adverse events
The Safety of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women, as assessed by recording the incidence of device related adverse events
Measured: 18 months
The Safety of intra-urethral/intravaginal Er:YAG laser procedure by measure uroflow and post void residual (PVR)
The Safety of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women, as assessed by measure uroflow and post void residual (PVR) 6 months after the 2ed treatment
Measured: 18 months
The Safety of intra-urethral/intravaginal Er:YAG laser procedure by Questionnaire for voiding symptoms (based on IPSS)
The Safety of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women, as assessed by questionnaire for voiding symptoms (based on IPSS)
Measured: 18 months
Secondary outcomes (4)
The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by recording 3-day voiding diary
The efficacy of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women by recording of improvement in daily number of incontinence episodes via 3-day voiding diary The 3-day voiding diary is a log used to record number of pads used, incontinence episodes, the activity in which the subject was engaged when the incontinence occurred, and micturitions.
Measured: 18 months
The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by 24-Hour Pad-Weight Test
The 24-Hour Pad-Weight Test will be used to reflect everyday incontinence. This test, standardized by the International Continence Society, correlates well with UI symptoms, and has good reproducibility.
Measured: 18 months
The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by ICIQ-UI short form questionnaire
The efficacy of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women reduction in SUI as measured by ICIQ-UI short form questionnaire. The ICIQ-UI Short Form Questionnaire provides a brief and robust measure to assess the impact of symptoms of incontinence on quality of life and outcome of treatment.
Measured: 18 months
The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by recording patient global impression of improvement (PGI-I)
- The efficacy of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women by recording patient global impression of improvement (PGI-I). The Patient Global Impression of Improvement (PGI-I) Questionnaire is a global index that may be used to rate the response of a condition to a therapy (transition scale).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start4 Jun 2018
- Primary completion28 Nov 2022
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Prospective, randomized, 3-arm parallel pilot study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fotona d.o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676894
- Sponsor's protocol ID
- SPD16-001-00
- Status last verified
- May 2023
- First submitted
- 10 Sep 2018
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Single-masked, Randomized, 3-arm Parallel Study Assessing the Tolerability, Safety and Efficacy of Intraurethral/Intravaginal 2940 Nm Er:YAG Laser Treatment for Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT03676894
- Acronym / sponsor ID
- SPD16-001-00
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Fotona d.o.o.Industry (pharma, biotech, devices)
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 28 Nov 2022 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 19 Sep 2018 (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.
Primary objective is to assess the tolerability and safety of the intraurethral 2940nm Er:YAG laser technique in combination with intravaginal 2940nm Er:YAG laser method for the treatment of stress urinary incontinence.
Detailed description
This study is a prospective, randomized, 3-arm parallel pilot study. Study subjects will be women currently experiencing female stress urinary incontinence (SUI) and stress-predominant mixed urinary incontinence (SMUI) with a degree of intrinsic sphincter deficiency for a minimum duration of 6 months prior to enrolment. Diagnosis of SUI with a degree of intrinsic sphincter deficiency will be performed using urodynamic and clinical assessment.
Subjects will undergo sham, intravaginal, and the combination of intravaginal and intraurethral treatment with the 2940 nm Er:yttrium aluminum garnet Er:YAG laser at two time points, 4 weeks apart. Primary objective is to assess the tolerability and safety of the intraurethral 2940nm Er:YAG laser technique in combination with intravaginal 2940nm Er:YAG laser method for the treatment of stress urinary incontinence through 6 months follow-up and extend to 12 months follow-up.
Secondary objective is to assess the effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments using subjective and objective measures, as well as improvement in quality of life through 6 months follow-up and extend to 12 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Prospective, randomized, 3-arm parallel pilot study
| Arm | Type | Receives |
|---|---|---|
| Sham Treatment | Sham comparator | Device: Sham Fotona SP DynamisSham Fotona SP Dynamis Treatment - minimum energy delivered through sham handpiece. |
| Intravaginal Treatment | Active comparator | Device: Intravaginal Fotona SP DynamisIntravaginal Fotona SP Dynamis Treatment - energy delivered intravaginally. |
| Intravaginal and intraurethral Treatment | Experimental | Device: Intravaginal Fotona SP Dynamis, Device: Intraurethral Fotona SP DynamisIntravaginal and intraurethral Fotona SP Dynamis Treatment Intravaginal Treatment - energy delivered intravaginally and intraurethrally. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female between 18 and 80 years
- SUI or MUI with predominantly stress symptoms for more than 6 months
- Has failed 2 previous non-invasive therapies for three (3) months each (e.g. behavioural modification, electrical stimulation, pelvic muscle exercise, biofeedback, and/or drug therapy)
- Confirmed SUI through cough stress test or urodynamics
- Has at least one incontinence episode per 24 hour period measured over three days
Key exclusion criteria (19 listed)
- Active urinary tract or vaginal infection or other active infections of urinary tract or bladder (urethritis, cystitis or vaginitis)
- Has had three (3) or more cultured-proven bacterial urinary tract infection (UTI) in the last 12 months
- Clinical diagnosis of urge incontinence or urge predominant mixed incontinence
- Has detrusor overactivity on urodynamics
- postvoiding residual (PVR) > 100 ml
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 |
|---|---|---|
| Sham Fotona SP DynamisFemale patients with SUI will be treated with non-ablative Er:YAG laser with Fotona SP Dynamis with sham handpiece. | Device | Sham Treatment |
| Intravaginal Fotona SP DynamisFemale patients with SUI will be treated intravaginaly with non-ablative Er:YAG laser with Fotona SP Dynamis | Device | Intravaginal Treatment, Intravaginal and intraurethral Treatment |
| Intraurethral Fotona SP DynamisFemale patients with SUI will be treated intraurethraly with non-ablative Er:YAG laser with Fotona SP Dynamis | Device | Intravaginal and intraurethral Treatment |
Primary outcome
Tolerability of the 2940nm Er:YAG laser technique by VAS pain scale
Time frame: 18 months
The tolerability of intra-urethral/intravaginal Er:YAG laser treatment by VAS pain scale during procedure and by monitoring the use of pain relieving medication post treatment. The Visual Analog Scale for Pain (VAS) is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations.
The Safety of intra-urethral/intravaginal Er:YAG laser procedure by recording the incidence and severity of complications
Time frame: 18 months
The Safety of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women, as assessed by recording the incidence and severity of complications
The Safety of intra-urethral/intravaginal Er:YAG laser procedure by recording the incidence of device related adverse events
Time frame: 18 months
The Safety of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women, as assessed by recording the incidence of device related adverse events
The Safety of intra-urethral/intravaginal Er:YAG laser procedure by measure uroflow and post void residual (PVR)
Time frame: 18 months
The Safety of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women, as assessed by measure uroflow and post void residual (PVR) 6 months after the 2ed treatment
The Safety of intra-urethral/intravaginal Er:YAG laser procedure by Questionnaire for voiding symptoms (based on IPSS)
Time frame: 18 months
The Safety of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women, as assessed by questionnaire for voiding symptoms (based on IPSS)
4 secondary outcomes
The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by recording 3-day voiding diary
Time frame: 18 months
The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by 24-Hour Pad-Weight Test
Time frame: 18 months
The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by ICIQ-UI short form questionnaire
Time frame: 18 months
The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by recording patient global impression of improvement (PGI-I)
Time frame: 18 months
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 13 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Stress Urinary Incontinence
RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravaginal Fotona SP Dynamis and Intraurethral Fotona SP Dynamis in people with Stress Urinary Incontinence, run by Fotona d.o.o. at 2 sites in Canada.
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 10 inclusion and 19 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 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
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?
Tolerability of the 2940nm Er:YAG laser technique by VAS pain scale (time frame: 18 months). The study lists 5 primary outcomes in all. 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 13 Mar 2025.