IUL Study A Randomized Sham - Controlled Clinical Study

NCT04707690 | Unknown DMC

• 1 other identifier: V1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stress Urinary Incontinence

Keywords

Laser therapy; Stress urinary incontinence; intraurethral

Outcome Measures

Primary Outcomes (1)

• 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).

  3 months

Secondary Outcomes (10)

• Degree of pain during laser therapy on a visual analogue scale (VAS)

  3 months

• Subjective SUI

  3 months

• Objective SUI

  3 months

• Patient Global Impression of Improvement

  3 months

• Patient Global Impression of Severity

  3 months

Study Arms (2)

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.

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.

Device: Intraurethral SHAM laser therapy

Interventions

Intraurethral laser therapy DEVICE

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.

Also known as: Fotona smooth XS laser

Intraurethral laser therapy

Intraurethral SHAM laser therapy DEVICE

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.

Also known as: Fotona smooth XS laser

Intraurethral SHAM laser therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Only females can participate in this study because it is led by gynecologists.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Departement of Obstetrics and Gynecology

Graz, Styria, 8036, Austria

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Daniela Gold, MD PhD

CONTACT

0043316 385 81437; daniela.gold@medunigraz.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Eligible patients will receive written and oral information about the study. After informed consent patients will be randomized into the intraurethral laser treatment group or sham laser group using the internet based program "randomizer", at a 1.1 ratio without stratification. Patients and the person performing the laser treatment will not aware of the treatment given. The laser devices can be used as a placebo laser blocking the laser beam with a plug.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective randomized sham - controlled trial

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 13, 2021
• Study Start: January 8, 2021
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)