ClinicalTrials.Veeva

Menu

Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol

S

Servicio de Salud Metropolitano Sur Oriente

Status

Unknown

Conditions

Quality of Life
Pelvic Organ Prolapse

Treatments

Device: Vaginal Pessary

Study type

Interventional

Funder types

Other

Identifiers

NCT02113969
SA12I2153

Details and patient eligibility

About

Genital prolapse is a common condition (up 20%), affecting the quality of life. Treatment can be surgical or conservative using vaginal pessaries. These devices are introduced into the vagina aiming to reduces the prolapse.

Pessaries have shown effectiveness in improving symptoms and quality of life. There are no randomized studies comparing them with surgery. This study design would be difficult to perform, because the inclusion criteria for both treatments are different. There are no currently standard protocols for the use of pessaries. This makes harder to widespread the usage of this conservative treatment.

The aim of the investigators is to identify variables that influence the success of conservative management of genital prolapse at 1 year of follow up. Using these variables and an expert panel opinion the investigators will develop a standardized protocol for pessary management.

Chile has a primary gynecological care system based midwives. Therefore having algorithms for pessaries usage becomes relevant. This algorithm can be implemented with basic training. This would increase the respond capacity, by the health care system to this disease, considering the scarce access to surgery.

The investigators hypothesis is: It is possible to generate a standardized protocol of conservative management of symptomatic genital prolapse in patient's beneficiary of public health system in Santiago, Chile, using pessaries through a prospective cohort study based in the success of these devices with 1 year of follow up, measured with questionnaires of symptoms, quality of life and sexuality

Enrollment

294 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Symptomatic Pelvic Organ Prolapse
  • Commitment to attend controls
  • Current negative cervical cytology
  • Informed consent signed

Exclusion criteria

  • Urinary incontinence as the only Pessary Indication
  • Vaginal bleeding of undetermined cause
  • Unable to return to controls

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

294 participants in 1 patient group

Vaginal Pessary
Experimental group
Description:
Pessary users for at least 12 months
Treatment:
Device: Vaginal Pessary

Trial contacts and locations

1

Loading...

Central trial contact

Bernardita Blumel, MD; Javier Pizarro, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems