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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02113969
Other study ID # SA12I2153
Secondary ID
Status Recruiting
Phase N/A
First received April 9, 2014
Last updated November 17, 2014
Start date September 2013
Est. completion date March 2016

Study information

Verified date November 2014
Source Servicio de Salud Metropolitano Sur Oriente
Contact Javier Pizarro, MD
Phone 216 583-6220
Email jpizarro@med.puc.cl
Is FDA regulated No
Health authority Chile: Comisión Nacional de Investigación Científica y TecnológicaChile: Comité de Ética CientíficoChile: Institutional Review BoardChile: Instituto de Salud Pública de ChileChile: Ministry of Health
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 294
Est. completion date March 2016
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
Chile Unidad de Uroginecologia, Complejo Asistencial Dr. Sotero del Rio Santiago Region Metropolitana

Sponsors (2)

Lead Sponsor Collaborator
Servicio de Salud Metropolitano Sur Oriente Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of Life changes in pessary users for symptomatic Pelvic Organs Prolapse At baseline, 6 and 12 month the Chilean Version of the P-QoL survey will be applied to describe the QoL changes 6 months and 12 months No
Primary Pelvic Floor Disorders symptoms changes in pessary users for symptomatic Pelvic Organs Prolapse At baseline, 6 and 12 month the Chilean Version of the Pelvic Distress Inventory - 20 (PDFI-20) survey will be applied to describe the symptoms changes 6 months and 12 months No
Primary Sexual response changes in pessary sexually active women users for symptomatic Pelvic Organs Prolapse At baseline, 6 and 12 month the Chilean Version of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) survey will be applied to describe the Sexually response changes 6 months and 12 months No
Primary Subjective impression of improvement after pessary use for symptomatic Pelvic Organs Prolapse At baseline, 6 and 12 month the Patient Global Impression of Improvement (PGI-I) survey will be applied to describe the subjective improvement 6 months and 12 months No
Primary Successful usage of pessary If an enrolled patients is still using the pessary as the treatment for the pelvic organ prolapse will be considered as "successful".
Risk factors for unsuccessful pessary used will be measure using baseline characteristics.
12 months No
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