Clinical trial NCT04707690: IUL Study A Randomized Sham - Controlled Clinical Study
Official title: Intraurethral Laser Therapy for Stress Urinary Incontinence: A Randomized Sham - Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Laser therapy
Stress urinary incontinence
intraurethral
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized sham - controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Subjective symptoms of SUI
timeFrame: 3 months
Secondary outcomes:
measure: Degree of pain during laser therapy on a visual analogue scale (VAS)
timeFrame: 3 months
measure: Subjective SUI
timeFrame: 3 months
measure: Objective SUI
timeFrame: 3 months
measure: Patient Global Impression of Improvement
timeFrame: 3 months
measure: Patient Global Impression of Severity
timeFrame: 3 months
measure: Quality of Life using the Kings Health Questionnaire
timeFrame: 3 months
measure: Pelvic floor symptoms
timeFrame: 3 months
measure: Pad Weight
timeFrame: 3 months
measure: Patient satisfaction with treatment/inpatient management
timeFrame: 3 months
measure: Microbiome
timeFrame: 3 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Departement of Obstetrics and Gynecology
state: Styria
Study officials:
References: