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Laser Therapy in Managing Vaginal Prolapse

N

National and Kapodistrian University of Athens

Status

Unknown

Conditions

Enterocele
Cystocele
Vaginal Vault Prolapse
Rectocele

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03714607
310/26-04-2018

Details and patient eligibility

About

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.

Full description

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.

Enrollment

30 patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Laser
Experimental group
Description:
Erbium Yttrium Aluminum Garnet (Er:YAG) laser therapies
Treatment:
Device: Erbium Yttrium Aluminum Garnet (Er:YAG) laser
Control
No Intervention group
Description:
No intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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