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

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Prolapse

Treatments: Procedure: Non-ablative vaginal Erbium YAG laser treatment; Other: Pelvic floor exercises (PFE)

Study type: Interventional

Funder types: Other

Identifiers

NCT04523298

S64093

Details and patient eligibility

About

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 prolapse (grade II-IV) who seek for a conservative treatment, with no history of previous POP-surgery will be randomised to either the laser-arm or the PFE-arm.

There are 3 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 reduction of prolapse symptoms and as a secondary outcome objective measurements. These endpoints are in line with the recommendations by Durnea et al., as being the most relevant and patient centered outcomes.

The second goals are to register adverse events and to determine for how long the effects of laser are sustained, with a maximum of two years. To do so, the investigators will measure long term satisfaction with, and the longevity of the effect (measured by the need for repeat or alternative therapy) of laser therapy.

Duration of follow-up per patient: max 27 months

Enrollment: 46 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The presence of POP symptoms
• Diagnosis of cystocele or rectocele of grade II to IV according to the POP-Q system, leading the prolapse (i.e. C ≤ Ba/Bp)
• Voluntary informed consent

Exclusion criteria

• Symptoms or anatomical evidence for intussusception / rectal prolapse
• Leading descent of the middle compartment (C > Ba/Bp)
• Grade IV prolapse
• Previous POP surgery
• Pregnancy or <12 months postpartum
• Vaginal bleeding, injuries or infection in the treated area

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Laser

Experimental group

Treatment:

Procedure: Non-ablative vaginal Erbium YAG laser treatment

PFE

Active Comparator group

Treatment:

Other: Pelvic floor exercises (PFE)