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

NCT04523298 | Completed DMC

• 1 other identifier: S64093
• Study Type: interventional
• Target: 46
• 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 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

Conditions

Prolapse

Keywords

laser; pelvic floor treatment

Outcome Measures

Primary Outcomes (1)

• Primary outcome is the subjective improvement of POP symptoms, assessed by the Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6).

  Participants have to answer 6 questions concerning POP symptoms with a response scale from 0 to 4 (not present (=0), not at all (=1), somewhat (=2), moderately (=3), quite a bit (=4)). The score (range 0 to 100) is then obtained by multiplying the mean value of all of the answered items by 25. Missing items are dealt with by using the mean from answered items only. Higher scores indicate more distress. This questionnaire is available and validated in English, Dutch and French. Success is defined as a reduction in scores of at least 25% compared with baseline.

  6 months after last treatment

Secondary Outcomes (6)

• Assessment of the anatomical success rate by means of the POP-Q system

  At every visit (ie. week 4, 8 and 12, optional: 16, 20 and 24 weeks), 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, optional: 16, 20 and 24 weeks), 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, optional: 16, 20 and 24 weeks), 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 treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment

• Assessment of sexual function, by means of the Pelvic Organ prolapse/Urinary Incontinence Sexual Questionnaire IUGA revised (PISQ-IR)

  At every visit (ie. week 4, 8 and 12, optional: 16, 20 and 24 weeks), 6, 12 and 24 months after end of treatment

Study Arms (2)

Laser

EXPERIMENTAL

Procedure: Non-ablative vaginal Erbium YAG laser treatment

PFE

ACTIVE COMPARATOR

Other: Pelvic floor exercises (PFE)

Interventions

Non-ablative vaginal Erbium YAG laser treatment PROCEDURE

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.

Laser

Pelvic floor exercises (PFE) OTHER

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.

PFE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

• Page AS, Borowski E, Bauters E, Housmans S, Van der Aa F, Deprest J. Vaginal erbium laser versus pelvic floor exercises for the treatment of pelvic organ prolapse: A randomised controlled trial. Eur J Obstet Gynecol Reprod Biol. 2024 Dec;303:165-170. doi: 10.1016/j.ejogrb.2024.10.042. Epub 2024 Oct 26.

  PMID: 39488138 DERIVED

MeSH Terms

Conditions

Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 21, 2020
• Study Start: November 8, 2020
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)