Pelvic Organ Prolapse, Quality of Life
Conditions
Keywords
Pelvic Organ Prolapse, Quality of Life, Symptoms, Pessary, 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
Interventions
DEVICEVaginal 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.
Sponsors
Pontificia Universidad Catolica de Chile
Servicio de Salud Metropolitano Sur Oriente
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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. |
Countries
Chile
Contacts
Primary ContactJavier Pizarro, MD
Backup ContactBernardita Blumel, MD
Outcome results
None listed