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

Not Applicable

• Conditions: Pelvic Organ Prolapse; Quality of Life

• Registration Number: NCT02113969
• Lead Sponsor: Servicio de Salud Metropolitano Sur Oriente

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-04-09
• Study First Submitted QC: 2014-04-10
• Study First Posted: 2014-04-15
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-18
• Primary Completion: 2015-03
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 294

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Quality of Life changes in pessary users for symptomatic Pelvic Organs Prolapse	6 months and 12 months	At baseline, 6 and 12 month the Chilean Version of the P-QoL survey will be applied to describe the QoL changes
Successful usage of pessary	12 months	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.
Sexual response changes in pessary sexually active women users for symptomatic Pelvic Organs Prolapse	6 months and 12 months	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	6 months and 12 months	At baseline, 6 and 12 month the Patient Global Impression of Improvement (PGI-I) survey will be applied to describe the subjective improvement
Pelvic Floor Disorders symptoms changes in pessary users for symptomatic Pelvic Organs Prolapse	6 months and 12 months	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

Trial Locations

Locations (1)

Unidad de Uroginecologia, Complejo Asistencial Dr. Sotero del Rio; 🇨🇱 Santiago, Region Metropolitana, Chile