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

NCT ID: NCT04643353

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-27
• Study Completion Date: 2023-12-30

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

Study Design

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

Study Groups

Non-ablative vaginal Erbium YAG laser treatment

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.

Group Type: EXPERIMENTAL

Non-ablative vaginal Erbium YAG laser treatment

Intervention Type: 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.

Pelvic floor exercises (PFE)

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.

Group Type: ACTIVE_COMPARATOR

PFE

Intervention Type: 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.

Interventions

Non-ablative vaginal Erbium YAG laser treatment

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.

Intervention Type: DEVICE

PFE

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

prof. dr. Jan Deprest

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jan Deprest, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

UZ Leuven

Leuven, , Belgium

Countries

Belgium

Other Identifiers

S64486

Identifier Type: -

Identifier Source: org_study_id