NCT03714607

Brief Summary

Efficacy of laser therapy in postmenopausal women with symptomatic prolapse stage \>1. Assessment tools will include prolapse stage quantification system (POP-Q) and validated condition related questionnaires.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 22, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

November 30, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

October 13, 2018

Last Update Submit

September 15, 2019

Conditions

CystoceleVaginal Vault ProlapseRectoceleEnterocele

Outcome Measures

Primary Outcomes (1)

  • Pelvic Organ Prolapse Quantification System (POP-Q)

    Physical examination

    Change from baseline to 4-6 months

Secondary Outcomes (6)

  • Pelvic Floor Distress Inventory Short Form (PFDI)

    Change from baseline το 4-6 months

  • International Consultation on Incontinence Modular Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)

    Change from baseline to 4-6 months

  • Pelvic Floor Impact Questionnaire short Form

    Change from baseline to 4-6 months

  • Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire Short form

    Change from baseline to 4-6 months

  • Patients Global Impression of Improvement

    4-6 months

  • +1 more secondary outcomes

Study Arms (2)

Laser

EXPERIMENTAL

Erbium Yttrium Aluminum Garnet (Er:YAG) laser therapies

Device: Erbium Yttrium Aluminum Garnet (Er:YAG) laser

Control

NO INTERVENTION

No intervention

Interventions

Erbium Yttrium Aluminum Garnet (Er:YAG) laserDEVICE

5 Er:YAG laser therapies vaginally administered at monthly intervals

Also known as: Fotona
Laser

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic prolapse stage \>1 (cystocele, vaginal vault prolapse, enterocele, rectocele) according to POP-Q System
  • Negative Pap-smear

You may not qualify if:

  • Asymptomatic prolapse
  • prolapse stage \<=1
  • prolapse of uterus
  • presence of any type of genital infections (i.e herpes, vaginitis etc)
  • vaginal bleeding
  • underlying pathologies that could interfere in patients compliance (i.e psychiatric)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urogynecological Unit of Alexandra Hospital

Athens, 11528, Greece

Location

Related Publications (1)

  • Athanasiou S, Pitsouni E, Cardozo L, Zacharakis D, Petrakis E, Loutradis D, Grigoriadis T. Can pelvic organ prolapse in postmenopausal women be treated with laser therapy? Climacteric. 2021 Feb;24(1):101-106. doi: 10.1080/13697137.2020.1789092. Epub 2020 Jul 28.

    PMID: 32720552DERIVED

MeSH Terms

Conditions

CystocelePelvic Organ ProlapseRectoceleHernia

Interventions

Lasers

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Stavros Athanasiou, Associate Proffesor

    National and Kapodistrian University of Athens, Greece

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 13, 2018

First Posted

October 22, 2018

Study Start

November 30, 2018

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

September 17, 2019

Record last verified: 2019-09

Locations

GR(1)