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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Servicio de Salud Metropolitano Sur Oriente
Sponsor:
Collaborator:
Pontificia Universidad Catolica de Chile
Information provided by (Responsible Party):
Servicio de Salud Metropolitano Sur Oriente
ClinicalTrials.gov Identifier:
NCT02113969
First received: April 9, 2014
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention
Pelvic Organ Prolapse
Quality of Life
Device: Vaginal Pessary

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol

Resource links provided by NLM:


Further study details as provided by Servicio de Salud Metropolitano Sur Oriente:

Primary Outcome Measures:
  • Quality of Life changes in pessary users for symptomatic Pelvic Organs Prolapse [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
    At baseline, 6 and 12 month the Chilean Version of the P-QoL survey will be applied to describe the QoL changes

  • Pelvic Floor Disorders symptoms changes in pessary users for symptomatic Pelvic Organs Prolapse [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
    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

  • Sexual response changes in pessary sexually active women users for symptomatic Pelvic Organs Prolapse [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
    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

  • Subjective impression of improvement after pessary use for symptomatic Pelvic Organs Prolapse [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
    At baseline, 6 and 12 month the Patient Global Impression of Improvement (PGI-I) survey will be applied to describe the subjective improvement

  • Successful usage of pessary [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 294
Study Start Date: September 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaginal Pessary
Pessary users for at least 12 months
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02113969

Contacts
Contact: Javier Pizarro, MD 216 583-6220 jpizarro@med.puc.cl
Contact: Bernardita Blumel, MD 56 9 82328165 bernarditablumel@gmail.com

Locations
Chile
Unidad de Uroginecologia, Complejo Asistencial Dr. Sotero del Rio Recruiting
Santiago, Region Metropolitana, Chile, 8207257
Contact: Javier Pizarro, MD    216-583-6220    jpizarro@med.puc.cl   
Contact: Bernardita Blumel, MD    56 9 8232 8165    bernarditablumel@gmail.com   
Principal Investigator: Javier Pizarro, MD         
Sub-Investigator: Bernardita Blumel, MD         
Sub-Investigator: Silvana Gonzalez, Midwife         
Sub-Investigator: Rodrigo Cuevas, MD         
Sub-Investigator: Alejandro Pattillo, MD         
Sub-Investigator: Marco Arellano, MD         
Sub-Investigator: Rodrigo Pineda, MD         
Sub-Investigator: Victor Miranda, Md, MsC         
Sub-Investigator: Oslando Padilla, MsC         
Sub-Investigator: Howard B Goldman, MD         
Sponsors and Collaborators
Servicio de Salud Metropolitano Sur Oriente
Pontificia Universidad Catolica de Chile
Investigators
Principal Investigator: Javier Pizarro, MD Complejo Asistencial Dr. Sotero del Rio
Study Director: Bernardita Blumel, MD Complejo Asistencial Dr. Sotero del Rio
Study Chair: Silvana Gonzalez, Midwife Complejo Asistencial Dr. Sotero del Rio
Study Director: Alejandro Pattillo, MD H. Dr. Sotero del Rio; Pontificia Universidad Católica de Chile
  More Information

No publications provided

Responsible Party: Servicio de Salud Metropolitano Sur Oriente
ClinicalTrials.gov Identifier: NCT02113969     History of Changes
Other Study ID Numbers: SA12I2153
Study First Received: April 9, 2014
Last Updated: April 10, 2014
Health Authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica
Chile: Comité de Ética Científico
Chile: Institutional Review Board
Chile: Instituto de Salud Pública de Chile
Chile: Ministry of Health

Keywords provided by Servicio de Salud Metropolitano Sur Oriente:
Pelvic Organ Prolapse
Quality of Life
Symptoms
Pessary
Treatment

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 28, 2014