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

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

Study Overview

• Status: Unknown
• Conditions: Quality of Life; Pelvic Organ Prolapse
• Intervention / Treatment: Device: Vaginal Pessary

• Study Type: Interventional
• Enrollment (Anticipated): 294
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Javier Pizarro, MD; Phone Number: 216 583-6220; Email: jpizarro@med.puc.cl
• Study Contact Backup: Name: Bernardita Blumel, MD; Phone Number: 56 9 82328165; Email: bernarditablumel@gmail.com

Study Locations

• Chile
  • Region Metropolitana
    • Santiago, Region Metropolitana, Chile, 8207257
      • Recruiting
      • Unidad de Uroginecologia, Complejo Asistencial Dr. Sotero del Rio
      • Contact: Javier Pizarro, MD; Phone Number: 216-583-6220; Email: jpizarro@med.puc.cl
      • Contact: Bernardita Blumel, MD; Phone Number: 56 9 8232 8165; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Servicio de Salud Metropolitano Sur Oriente
• Collaborators: Pontificia Universidad Catolica de Chile
• Investigators: Principal Investigator: Javier Pizarro, MD, Complejo Asistencial Dr. Sotero del Río; Study Director: Bernardita Blumel, MD, Complejo Asistencial Dr. Sotero del Río; Study Chair: Silvana Gonzalez, Midwife, Complejo Asistencial Dr. Sotero del Río; Study Director: Alejandro Pattillo, MD, H. Dr. Sotero del Rio; Pontificia Universidad Católica de Chile

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): March 1, 2015
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: April 9, 2014
• First Submitted That Met QC Criteria: April 10, 2014
• First Posted (Estimate): April 15, 2014

Study Record Updates

• Last Update Posted (Estimate): November 18, 2014
• Last Update Submitted That Met QC Criteria: November 17, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Treatment; Quality of Life; Pelvic Organ Prolapse; Pessary; Symptoms
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: SA12I2153