Laser Therapy in Managing Vaginal Prolapse

NCT ID: NCT03714607

Last Updated: 2019-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2020-01-31

Brief Summary

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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.

Detailed Description

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Postmenopausal women with symptomatic cystocele and/or rectocele stage 2 or 3 will be 1:1 randomly allocated to Er:YAG laser or watchful waiting group. Participants in the Er:YAG laser group will receive laser therapies at monthly intervals, while participants in the watchful waiting group will receive no treatment. All outcomes in both groups will be evaluated at baseline, 4-months and 6-months from baseline.

Conditions

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Cystocele Vaginal Vault Prolapse Rectocele Enterocele

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Laser

Erbium Yttrium Aluminum Garnet (Er:YAG) laser therapies

Group Type EXPERIMENTAL

Erbium Yttrium Aluminum Garnet (Er:YAG) laser

Intervention Type DEVICE

5 Er:YAG laser therapies vaginally administered at monthly intervals

Control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Erbium Yttrium Aluminum Garnet (Er:YAG) laser

5 Er:YAG laser therapies vaginally administered at monthly intervals

Intervention Type DEVICE

Other Intervention Names

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Fotona

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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)
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National and Kapodistrian University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Themos Grigoriadis

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stavros Athanasiou, Associate Proffesor

Role: STUDY_DIRECTOR

National and Kapodistrian University of Athens, Greece

Locations

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Urogynecological Unit of Alexandra Hospital

Athens, , Greece

Site Status

Countries

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Greece

References

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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.

Reference Type DERIVED
PMID: 32720552 (View on PubMed)

Other Identifiers

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310/26-04-2018

Identifier Type: -

Identifier Source: org_study_id

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