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

NCT ID: NCT02113969

Last Updated: 2014-11-18

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

294 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Pelvic Organ Prolapse Quality of Life

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vaginal Pessary

Pessary users for at least 12 months

Group Type EXPERIMENTAL

Vaginal Pessary

Intervention Type DEVICE

Pessary fitting session at recruitment, follow up at 1 week, then monthly to complete 1 year follow up. QoL, symptoms and sexual function Surveys will be conducted at recruitment, 6 and 12 month. The absence of bacterial vaginosis (through study of vaginal discharge and pH) will be checked prior to positioning pessary and then each control. At the end of follow up period the success related variables will be determine with a statistical model. This information will be analyzed by an expert panel aiming to identify relevant clinical variables not included. This panel will generate a Standardized Management Protocol for symptomatic pelvic organ prolapse using vaginal pessaries.

Interventions

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Vaginal Pessary

Pessary fitting session at recruitment, follow up at 1 week, then monthly to complete 1 year follow up. QoL, symptoms and sexual function Surveys will be conducted at recruitment, 6 and 12 month. The absence of bacterial vaginosis (through study of vaginal discharge and pH) will be checked prior to positioning pessary and then each control. At the end of follow up period the success related variables will be determine with a statistical model. This information will be analyzed by an expert panel aiming to identify relevant clinical variables not included. This panel will generate a Standardized Management Protocol for symptomatic pelvic organ prolapse using vaginal pessaries.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role collaborator

Servicio de Salud Metropolitano Sur Oriente

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Javier Pizarro, MD

Role: PRINCIPAL_INVESTIGATOR

Complejo Asistencial Dr. Sotero del Rio

Bernardita Blumel, MD

Role: STUDY_DIRECTOR

Complejo Asistencial Dr. Sotero del Rio

Silvana Gonzalez, Midwife

Role: STUDY_CHAIR

Complejo Asistencial Dr. Sotero del Rio

Alejandro Pattillo, MD

Role: STUDY_DIRECTOR

H. Dr. Sotero del Rio; Pontificia Universidad Católica de Chile

Locations

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Unidad de Uroginecologia, Complejo Asistencial Dr. Sotero del Rio

Santiago, Santiago Metropolitan, Chile

Site Status RECRUITING

Countries

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Chile

Central Contacts

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Javier Pizarro, MD

Role: CONTACT

[email protected]
216 583-6220

Bernardita Blumel, MD

Role: CONTACT

[email protected]
56 9 82328165

Facility Contacts

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Javier Pizarro, MD

Role: primary

[email protected]
216-583-6220

Bernardita Blumel, MD

Role: backup

[email protected]
56 9 8232 8165

References

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Arellano M, Santis-Moya F, Maluenda A, Pattillo A, Blumel B, Pohlhammer D, Gonzalez S, Pizarro-Berdichevsky J. Prevalence of colorectal symptoms and anal incontinence in patients with pelvic organ prolapse attended at an outpatient urogynecology service. Rev Bras Ginecol Obstet. 2024 Mar 15;46:e-rbgo10. doi: 10.61622/rbgo/2024AO10. eCollection 2024.

Reference Type DERIVED
PMID: 38765524 (View on PubMed)

Other Identifiers

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SA12I2153

Identifier Type: -

Identifier Source: org_study_id