IUL Study A Randomized Sham - Controlled Clinical Study

NCT ID: NCT04707690

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-08
• Study Completion Date: 2025-01-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intraurethral laser therapy

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.

Group Type: ACTIVE_COMPARATOR

Intraurethral laser therapy

Intervention Type: 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.

Intraurethral SHAM laser therapy

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.

Group Type: PLACEBO_COMPARATOR

Intraurethral SHAM laser therapy

Intervention Type: 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.

Interventions

Intraurethral laser therapy

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.

Intervention Type: DEVICE

Intraurethral SHAM laser therapy

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.

Intervention Type: DEVICE

Other Intervention Names

Fotona smooth XS laser; Fotona smooth XS laser

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Vaginal delivery within 6 months prior to the Screening/Baseline Visit

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Departement of Obstetrics and Gynecology

Graz, Styria, Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Daniela Gold, MD PhD

Role: CONTACT

daniela.gold@medunigraz.at

0043316 385 81437

Facility Contacts

Daniela Gold, MD PhD

Role: primary

daniela.gold@medunigraz.at

0043316 385 81437

Other Identifiers

V1

Identifier Type: -

Identifier Source: org_study_id