IUL Study A Randomized Sham - Controlled Clinical Study

Last updated: January 17, 2024
Sponsor: Medical University of Graz
Overall Status: Active - Recruiting

Phase

N/A

Condition

Enuresis

Urinary Incontinence

Treatment

Intraurethral laser therapy

Intraurethral SHAM laser therapy

Clinical Study ID

NCT04707690
V1
  • Ages 18-80
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 daysaccording 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 haveresidual or recurrent SUI following colposuspension or a sling procedure may beincluded in the study if the procedure was conducted at least 6 months prior toscreening /baseline visit)
  • BMI (body mass index) ≤35 kg/m2
  • Willing to give informed consent and complete the follow up schedule

Exclusion

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

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Intraurethral laser therapy
Phase:
Study Start date:
January 08, 2021
Estimated Completion Date:
January 01, 2025

Study 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.

Connect with a study center

  • Departement of Obstetrics and Gynecology

    Graz, Styria 8036
    Austria

    Active - Recruiting

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