Clinical trial NCT04523298: Use of Non-ablative Vaginal Erbium YAG Laser for the Treatment of Prolapse
Official title: Use of Non-ablative Vaginal Erbium YAG Laser for the Treatment of Prolapse: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prolapse
Keywords: laser
pelvic floor treatment
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-08-21
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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


Eligibility criteria: 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

Primary outcomes:
measure: Primary outcome is the subjective improvement of POP symptoms, assessed by the Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6).
timeFrame: 6 months after last treatment
Secondary outcomes:
measure: Assessment of the anatomical success rate by means of the POP-Q system
timeFrame: At every visit (ie. week 4, 8 and 12, optional: 16, 20 and 24 weeks), 6, 12 and 24 months after end of treatment
measure: Assessment of the rate of patient satisfaction by means of the Patient Global Impression of Improvement (PGI)
timeFrame: At every visit (ie. week 4, 8 and 12, optional: 16, 20 and 24 weeks), 6, 12 and 24 months after end of treatment
measure: Assessment of the degree of discomfort of the treatment procedure by the patient
timeFrame: At every visit (ie. week 4, 8 and 12, optional: 16, 20 and 24 weeks), 6, 12 and 24 months after end of treatment
measure: Assessment of the longevity of the effect of laser therapy
timeFrame: At every visit (ie. week 4, 8 and 12), end of treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment
measure: Assessment of sexual function, by means of the Pelvic Organ prolapse/Urinary Incontinence Sexual Questionnaire IUGA revised (PISQ-IR)
timeFrame: At every visit (ie. week 4, 8 and 12, optional: 16, 20 and 24 weeks), 6, 12 and 24 months after end of treatment
measure: Assessment of urinary symptoms by means of the Urogenital Distress Inventory (UDI-6)
timeFrame: At every visit (ie. week 4, 8 and 12, optional: 16, 20 and 24 weeks), 6, 12 and 24 months after end of treatment
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References: