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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02113969
• Other study ID #: SA12I2153
• 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

• Pelvic Organ Prolapse
• Prolapse
• Quality of Life

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