Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol
|ClinicalTrials.gov Identifier: NCT02113969|
Recruitment Status : Unknown
Verified November 2014 by Servicio de Salud Metropolitano Sur Oriente.
Recruitment status was: Recruiting
First Posted : April 15, 2014
Last Update Posted : November 18, 2014
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 or disease||Intervention/treatment||Phase|
|Pelvic Organ Prolapse Quality of Life||Device: Vaginal Pessary||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||294 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||March 2015|
|Estimated Study Completion Date :||March 2016|
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.
- Quality of Life changes in pessary users for symptomatic Pelvic Organs Prolapse [ Time Frame: 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
- Pelvic Floor Disorders symptoms changes in pessary users for symptomatic Pelvic Organs Prolapse [ Time Frame: 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
- Sexual response changes in pessary sexually active women users for symptomatic Pelvic Organs Prolapse [ Time Frame: 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 [ Time Frame: 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
- Successful usage of pessary [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02113969
|Contact: Javier Pizarro, MD||216 firstname.lastname@example.org|
|Contact: Bernardita Blumel, MD||56 9 email@example.com|
|Unidad de Uroginecologia, Complejo Asistencial Dr. Sotero del Rio||Recruiting|
|Santiago, Region Metropolitana, Chile, 8207257|
|Contact: Javier Pizarro, MD 216-583-6220 firstname.lastname@example.org|
|Contact: Bernardita Blumel, MD 56 9 8232 8165 email@example.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|
|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|