Clinical trial NCT02113969: Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol
Official title: Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Organ Prolapse
Quality of Life
Keywords: Pelvic Organ Prolapse
Quality of Life
Symptoms
Pessary
Treatment
Lead sponsor: Servicio de Salud Metropolitano Sur Oriente
Sponsor class: OTHER_GOV
Collaborators: name: Pontificia Universidad Catolica de Chile
First posted: 2014-04-15
Enrollment: 294
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Quality of Life changes in pessary users for symptomatic Pelvic Organs Prolapse
timeFrame: 6 months and 12 months
measure: Pelvic Floor Disorders symptoms changes in pessary users for symptomatic Pelvic Organs Prolapse
timeFrame: 6 months and 12 months
measure: Sexual response changes in pessary sexually active women users for symptomatic Pelvic Organs Prolapse
timeFrame: 6 months and 12 months
measure: Subjective impression of improvement after pessary use for symptomatic Pelvic Organs Prolapse
timeFrame: 6 months and 12 months
measure: Successful usage of pessary
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Unidad de Uroginecologia, Complejo Asistencial Dr. Sotero del Rio
state: Region Metropolitana
Study officials:
affiliation: Complejo Asistencial Dr. Sotero del Rio
name: Javier Pizarro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Complejo Asistencial Dr. Sotero del Rio
name: Bernardita Blumel, MD
role: STUDY_DIRECTOR
affiliation: Complejo Asistencial Dr. Sotero del Rio
name: Silvana Gonzalez, Midwife
role: STUDY_CHAIR
affiliation: H. Dr. Sotero del Rio; Pontificia Universidad Católica de Chile
name: Alejandro Pattillo, MD
role: STUDY_DIRECTOR
References: