Stress Urinary IncontinenceNCT04707690
IUL Study A Randomized Sham - Controlled Clinical Study
A study testing Intraurethral laser therapy in people with Stress Urinary Incontinence, run by Medical University of Graz at 1 site in Austria.
Trial summary
Primary aim of the study is to compare the impact of SUI on the VAS (visual analogue scale) 3 months after laser therapy versus sham laser therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Intraurethral laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 8 Jan 2021to 1 Jan 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female between 18 and 80 years
- Confirmed SUI through cough stress test within the last 24 months
- SUI I-II° for more than 6 months
- At least one incontinence episode per 24 hour period measured over three days according to a bladder diary
- Valsalva leak-point pressure (VLPP) ≤60 cm H2O
- Maximum cystometric capacity ≥250 mL
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- 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)
- BMI (body mass index) ≤35 kg/m2
- Willing to give informed consent and complete the follow up schedule
Who cannot join
- Active lower urinary tract infections (urethritis, cystitis or vaginitis)
- Three (3) or more cultured-proven bacterial urinary tract infection (UTI) in the last 12 months
- Detrusor overactivity on urodynamics
- Postvoiding residual (PVR) > 100 ml
- Previous urethral surgery (i.e. fistula or diverticula)
- Pelvic organ prolapse grade > 3 as defined by POP-Q and symptomatic
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- Known polyuria (>3l/24h)
- Unevaluated macro hematuria
- 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
- Uncontrolled diabetes
- Active herpes genitalis
- Pregnancy
- Vaginal delivery within 6 months prior to the Screening/Baseline Visit
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Departement of Obstetrics and Gynecology
Graz, Styria, 8036
Daniela Gold, MD PhD, 0043316 385 81437, daniela.gold@medunigraz.at
Daniela Gold, M.D. PhD
About this study
Official title: Intraurethral Laser Therapy for Stress Urinary Incontinence: A Randomized Sham - Controlled Clinical Study
Primary aim of the study is to compare the impact of SUI on the VAS (visual analogue scale) 3 months after laser therapy versus sham laser therapy.
Read the detailed description
Background: Stress urinary incontinence (SUI) has a huge impact on the quality of life (QoL) in women and its treatment is challenging. Intraurethral laser may be an additional treatment option.
Study aim: The aim is to study the effectiveness of intraurethral laser therapy in women with SUI.
Design: randomized double blinded sham - controlled clinical study
Study population: women which have been diagnosed with SUI I-II°, aged between 18-80 years.
Study groups: Participants will be randomized (1:1), without stratification. The Intervention group will receive 2 treatments of intraurethral laser therapy and the Control group will receive 2 treatments of intraurethral SHAM laser therapy.
Sample size: A sample size of 20 women, 8 per group including a 20% Drop Out Rate, was calculated.
Primary outcome: impact of SUI on the VAS scale 3 months after laser therapy versus sham laser therapy.
Secondary study outcomes were defined as subjective SUI, objective SUI, QoL, treatment satisfaction, intraurethral microbiome, 3 months after laser therapy versus sham laser therapy.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Intraurethral laser therapy, Intraurethral SHAM laser therapy
- Keywords
- Laser therapy, Stress urinary incontinence, intraurethral
- 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.
Intraurethral laser therapyDevice
Also called Fotona smooth XS laser
The laser will be applied according to the manufacturer's protocol. This includes a 2 step laser treatment using 2 different modes at 2 timepoints. The treatment takes about 15 minutes time.
Intraurethral SHAM laser therapyDevice
Also called Fotona smooth XS laser
The laser will be applied according to the manufacturer's protocol. This includes a 2 step laser treatment using 2 different modes at 2 timepoints. The treatment takes about 15 minutes time.
| Study group | Role | What they receive |
|---|---|---|
| Intraurethral laser therapy | Active comparator | Before treatment the vulva will be carefully inspected to rule out signs of infection or recent trauma. A local anesthetic fluid (Cathejell ®) will be applied to the urethral meatus. Before laser therapy, an intraurethral swab will be taken before treatment in order to determine the intraurethral microbiome.
Vulvovaginal laser therapies will be performed with the non-ablative 2940 nm Er:YAG laser (Smooth XS, Fotona, Slovenia) in the Incontinence mode according to the manufacturer's guidelines and recommendations. The spot size (diameter of the laser beam) is 7 mm, with a pulse at a frequency of 1.6 Hz, and a fluence (laser energy delivered per unit area) of 5.0 to 10.0 J/cm2. Receives: Device: Intraurethral laser therapy |
| Intraurethral SHAM laser therapy | Placebo comparator | Clinical examination and preparations will be identical to the intervention group. Sham laser treatments will be performed with the same laser and the same device. However, a specially designed placebo probe, which blocks the emission of radiation, will be used. Women will therefore receive no therapeutic laser treatment. Before treatment, a study assistant, who is aware of the study allocation, will prepare the laser with the placebo probe, which looks identically to the "normal" probe. The treating physician will not be aware of the study allocation and the type of probe in use. Receives: Device: Intraurethral SHAM laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective symptoms of SUI
A visual analogue scale (VAS) is used for assessment for the subjective symptoms and improvement of SUI. Patients are asked to indicate the degree of their symptoms on a scle ranging from 0 (no symptoms) to 10 (worst possible symptoms).
Measured: 3 months
Secondary outcomes (10)
Degree of pain during laser therapy on a visual analogue scale (VAS)
Patients are asked to indicate the degree of pain during laser therapy on a visual analogue scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain).
Measured: 3 months
Subjective SUI
Subjective SUI as determined by the question "do you leak urine when coughing, sneezing or laughing" with the answer possibilities of "Yes" and "No".
Measured: 3 months
Objective SUI
Objective SUI as determined by the cough stress test at 300ml bladder filling, which will either be positive or negative.
Measured: 3 months
Patient Global Impression of Improvement
The PGI-I scales are robust and valid instruments to assess disease severity, bother and improvement after treatment in women and will be used to determine the Patient Global Impression of Improvement. The PGI-I consists of a 7-likert-scale with 7 being the worst bother.
Measured: 3 months
Patient Global Impression of Severity
The Patient Global Impression of Severity (PGI-S) is a global index that may be used to rate the severity of a specific condition (in a single-state scale). The PGI-I scales are robust and valid instruments to assess disease severity, bother and improvement after treatment in women and will be used to determine the Patient Global Impression of Severity. The PGI scales are robust and valid instruments to assess disease severity, bother and improvement after treatment. The patient can choose from 4 answers including none, mild, moderate and severe.
Measured: 3 months
Quality of Life using the Kings Health Questionnaire
The Kings Health Questionnaire was validated in women with stress urinary incontinence and assesses the impact of incontinence on quality of life. The eight subscales ("domains") scored between 0 (best) and 100 (worst). The Symptom Severity scale is scored from 0 (best) to 30 (worst); lower scores indicate better QoL. Success in terms of the study is defined as 10 points improvement on the total Kings Health Questionnaire score.
Measured: 3 months
Pelvic floor symptoms
A validated self-administered pelvic floor questionnaire (Baessler) will be used to assess urogentinal symptoms. Questions regarding bladder (15), bowel (12), and sexual function (10), and pelvic organ prolapse symptoms (five) are grouped according to the physiological functions of the pelvic floor: bladder function, bowel function, prolapse symptoms, and sexual function domains. Quality of life measures and bothersomeness ratings were integrated into the four domains. Frequency, severity, and bothersomeness of pelvic floor symptoms are assessed using a four-point scoring system for most items in the questionnaire, apart from defecation frequency, bowel consistency, sufficient lubrication, and the reason for sexual abstinence. The lower the score the less pelvic floor symptoms the patients have.
Measured: 3 months
Pad Weight
In regards to the one-hour stress pad weight test women are asked to drink 500 ml of sodium-free liquid in <15 min, then sit, walk for 30 min including climbing one flight of stairs. Afterwards the total amount of urine leaked is determined by weighing the pad. Lower weight means less urine loss.
Measured: 3 months
Patient satisfaction with treatment/inpatient management
Patient satisfaction will be evaluated with the "Fragebogen zur Patientenzufriedenheit - ZUF-8". The German version of the original "Client Satisfaction Questionnaire-CSQ8", is a validated tool for measuring global patient satisfaction at the end of inpatient treatment. The ZUF-8 is an 8-items questionnaire to assess satisfaction in patients undergoing inpatient treatment. At 3 months treatment satisfaction will be assessed using an adopted version of the questionnaire. The lower the score, the higher is the patient satisfaction.
Measured: 3 months
Microbiome
Extraction of archaeal/bacterial 16S rRNA gene using the Illumina MiSeq platform in order to determine the intraurethral microbiome
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start8 Jan 2021
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
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 sham - controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707690
- Sponsor's protocol ID
- V1
- Status last verified
- Jan 2024
- First submitted
- 12 Jan 2021
- Last updated
- 18 Jan 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 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraurethral Laser Therapy for Stress Urinary Incontinence: A Randomized Sham - Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT04707690
- Acronym / sponsor ID
- V1
- Conditions
- Stress Urinary Incontinence
- Keywords
- Laser therapy, Stress urinary incontinence, intraurethral
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 13 Jan 2021 (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 aim of the study is to compare the impact of SUI on the VAS (visual analogue scale) 3 months after laser therapy versus sham laser therapy.
Detailed description
Background: Stress urinary incontinence (SUI) has a huge impact on the quality of life (QoL) in women and its treatment is challenging. Intraurethral laser may be an additional treatment option.
Study aim: The aim is to study the effectiveness of intraurethral laser therapy in women with SUI.
Design: randomized double blinded sham - controlled clinical study
Study population: women which have been diagnosed with SUI I-II°, aged between 18-80 years.
Study groups: Participants will be randomized (1:1), without stratification. The Intervention group will receive 2 treatments of intraurethral laser therapy and the Control group will receive 2 treatments of intraurethral SHAM laser therapy.
Sample size: A sample size of 20 women, 8 per group including a 20% Drop Out Rate, was calculated.
Primary outcome: impact of SUI on the VAS scale 3 months after laser therapy versus sham laser therapy.
Secondary study outcomes were defined as subjective SUI, objective SUI, QoL, treatment satisfaction, intraurethral microbiome, 3 months after laser therapy versus sham laser therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Prospective randomized sham - controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intraurethral laser therapy | Active comparator | Device: Intraurethral laser therapyBefore treatment the vulva will be carefully inspected to rule out signs of infection or recent trauma. A local anesthetic fluid (Cathejell ®) will be applied to the urethral meatus. Before laser therapy, an intraurethral swab will be taken before treatment in order to determine the intraurethral microbiome. Vulvovaginal laser therapies will be performed with the non-ablative 2940 nm Er:YAG laser (Smooth XS, Fotona, Slovenia) in the Incontinence mode according to the manufacturer's guidelines and recommendations. The spot size (diameter of the laser beam) is 7 mm, with a pulse at a frequency of 1.6 Hz, and a fluence (laser energy delivered per unit area) of 5.0 to 10.0 J/cm2. |
| Intraurethral SHAM laser therapy | Placebo comparator | Device: Intraurethral SHAM laser therapyClinical examination and preparations will be identical to the intervention group. Sham laser treatments will be performed with the same laser and the same device. However, a specially designed placebo probe, which blocks the emission of radiation, will be used. Women will therefore receive no therapeutic laser treatment. Before treatment, a study assistant, who is aware of the study allocation, will prepare the laser with the placebo probe, which looks identically to the "normal" probe. The treating physician will not be aware of the study allocation and the type of probe in use. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female between 18 and 80 years
- Confirmed SUI through cough stress test within the last 24 months
- SUI I-II° for more than 6 months
- At least one incontinence episode per 24 hour period measured over three days according to a bladder diary
- Valsalva leak-point pressure (VLPP) ≤60 cm H2O
Key exclusion criteria (16 listed)
- Active lower urinary tract infections (urethritis, cystitis or vaginitis)
- Three (3) or more cultured-proven bacterial urinary tract infection (UTI) in the last 12 months
- Detrusor overactivity on urodynamics
- Postvoiding residual (PVR) > 100 ml
- Previous urethral surgery (i.e. fistula or diverticula)
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 |
|---|---|---|
| Intraurethral laser therapyAlso: Fotona smooth XS laserThe laser will be applied according to the manufacturer's protocol. This includes a 2 step laser treatment using 2 different modes at 2 timepoints. The treatment takes about 15 minutes time. | Device | Intraurethral laser therapy |
| Intraurethral SHAM laser therapyAlso: Fotona smooth XS laserThe laser will be applied according to the manufacturer's protocol. This includes a 2 step laser treatment using 2 different modes at 2 timepoints. The treatment takes about 15 minutes time. | Device | Intraurethral SHAM laser therapy |
Primary outcome
Subjective symptoms of SUI
Time frame: 3 months
A visual analogue scale (VAS) is used for assessment for the subjective symptoms and improvement of SUI. Patients are asked to indicate the degree of their symptoms on a scle ranging from 0 (no symptoms) to 10 (worst possible symptoms).
10 secondary outcomes
Degree of pain during laser therapy on a visual analogue scale (VAS)
Time frame: 3 months
Subjective SUI
Time frame: 3 months
Objective SUI
Time frame: 3 months
Patient Global Impression of Improvement
Time frame: 3 months
Patient Global Impression of Severity
Time frame: 3 months
Quality of Life using the Kings Health Questionnaire
Time frame: 3 months
Pelvic floor symptoms
Time frame: 3 months
Pad Weight
Time frame: 3 months
Patient satisfaction with treatment/inpatient management
Time frame: 3 months
Microbiome
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraurethral laser therapy in people with Stress Urinary Incontinence, run by Medical University of Graz at 1 site in Austria.
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 9 inclusion and 16 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 18 Jan 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 Austria. 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 Daniela Gold, MD PhD (0043316 385 81437, daniela.gold@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective symptoms of SUI (time frame: 3 months). 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 18 Jan 2024.