Use of Non-ablative Vaginal Erbium YAG Laser for the Treatment of Prolapse

NACompletedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

November 8, 2020

Primary Completion Date

December 30, 2023

Study Completion Date

December 30, 2023

Conditions
Prolapse
Interventions
PROCEDURE

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(24)) with SMOOTH mode setting, which enables non-ablative, thermal-only operation(25). The parameters are selected based on extensive preclinical and clinical studies(26,27,28).~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."

OTHER

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.

Trial Locations (1)

3000

UZ Leuven, Leuven

All Listed Sponsors
lead

Universitaire Ziekenhuizen KU Leuven

OTHER

NCT04523298 - Use of Non-ablative Vaginal Erbium YAG Laser for the Treatment of Prolapse | Biotech Hunter | Biotech Hunter