Use of Non-ablative Vaginal Erbium YAG Laser for the Treatment of Stress Urinary Incontinence.

NCT04643353 | Completed DMC

• 1 other identifier: S64486
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, investigator initiated study, sponsored by the UZ Leuven, Leuven, Belgium; comparing laser treatment to pelvic floor exercises (PFE). Women with symptomatic stress urinary incontinence who seek for a conservative treatment, with no history of previous incontinence-surgery will be randomised to either the laser-arm or the PFE-arm. There are 3 visits (with a maximum of 6 visits) where vaginal application of laser will be performed, with a 4-weeks interval. Each application lasts around 15 minutes. The vaginal laser procedure will be performed in an outpatient setting, not requiring any specific preparation, analgesia or anesthesia, by one of two experienced operators. The primary objective is to evaluate the effects of VEL treatment for the subjective cure or improvement of SUI. The secondary objectives are to measure objective outcomes, to register any adverse events, and to determine for how long the effects of laser are sustained, with a maximum of two years.

Conditions

Urinary Incontinence,Stress

Outcome Measures

Primary Outcomes (1)

• Primary outcome is the subjective success rate (cure or improvement) of SUI

  The tool used is the UDI-6 questionnaire. Converted UDI-6 scores range between 0 and 300. The "minimum important difference" is defined as a (MID)=11. In that score, cure is defined as answering "No" (0) to the question "Do you experience urine leakage related to physical activity, coughing or sneezing?".

  4 months after randomisation

Secondary Outcomes (7)

• Assessment of overall urinary symptoms by means of the Urogenital Distress Inventory (UDI-6).

  At every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment

• Assessment of the objective success rate by means of the cough stress test (CST).

  At every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment

• Assessment of the rate of patient satisfaction by means of the Patient Global Impression of Improvement (PGI)

  At every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment

• Assessment of the degree of discomfort of the treatment procedure by the patient

  At every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment

• Assessment of the longevity of the effect of laser therapy

  At every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment

Study Arms (2)

Non-ablative vaginal Erbium YAG laser treatment

EXPERIMENTAL

There are 3 visits where vaginal application of laser will be performed, with a 4-weeks interval. If needed, 3 extra laser applications can be added to the treatment (ie. with a maximum of 6 applications). Each application lasts around 15 minutes. The vaginal laser procedure will be performed in an outpatient setting, not requiring any specific preparation, analgesia or anesthesia, by one of two experienced operators. Laser therapy is performed using a 2940 nm VEL (SP Spectro, Fotona, Slovenia)with SMOOTH mode setting, which enables non-ablative, thermal-only operation). The parameters are selected based on extensive preclinical and clinical studies. Each laser treatment session consists of a full vaginal canal irradiation (using a 360° circular adapter), followed by additional irradiation of the prolapsed anterior wall (using a 90° angular adaptor) and concluded with irradiation of the vestibule area.

Device: Non-ablative vaginal Erbium YAG laser treatment

Pelvic floor exercises (PFE)

ACTIVE COMPARATOR

Standard PFE in Belgium are 9 sessions with a pelvic floor physiotherapist of choice, which can be extended by another 9 sessions, if clinically indicated. There are different strategies, though that will be on discretion of the physiotherapist. We will register the type of physiotherapy (standard (PFMT) versus assisted pelvic floor muscles training (APFMT)), number of completed sessions and duration of therapy. What is exactly done by the patient is registered as a variable.

Other: PFE

Interventions

Non-ablative vaginal Erbium YAG laser treatment DEVICE

Laser therapy is performed using a 2940 nm VEL (SP Spectro, Fotona, Slovenia) with SMOOTH mode setting, which enables non-ablative, thermal-only operation. The parameters are selected based on extensive preclinical and clinical studies.

Non-ablative vaginal Erbium YAG laser treatment

PFE OTHER

PFE will be prescribed as it is already implemented in clinical practice (i.e. up to 2x 9 sessions with a pelvic floor physiotherapist of choice). Type of physiotherapy, number of completed sessions and duration of therapy will be recorded.

Pelvic floor exercises (PFE)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The presence of mild (score 1-2) to moderate (3-6) SUI with wish for treatment. The patient can have concomitant urge urinary incontinence (UUI), but that should not be the leading factor. Incontinence severity will be categorized by the four-level Sandvik severity index score (SIS). Scores are from 0 to 12. The higher the score, the more severe the urinary incontinence (mild=1-2, moderate= 3-6, severe=8-9, very severe=12).
• Voluntary informed consent

You may not qualify if:

• Any previous PFE-treatment in the last year for the same problem
• Previous surgery for incontinence or prolapse
• Severe (Sandvik SIS ≥8) SUI or insensible loss, high suspicion of intrinsic sphincter deficiency (ISD)
• Prolapse grade III or more
• Pregnancy
• Vaginal bleeding, injuries or infection in the treated area

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

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

Study Officials

• Jan Deprest, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: November 25, 2020
• Study Start: November 27, 2020
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: September 26, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)