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

Sponsor

Servicio de Salud Metropolitano Sur Oriente (Other)

Overall Status

Unknown status

CT.gov ID

NCT02113969

Collaborator

Pontificia Universidad Catolica de Chile (Other)

294

Enrollment

Location

Arm

Duration (Months)

9.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse Quality of Life	Device: Vaginal Pessary	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

294 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2013

Anticipated Primary Completion Date :

Mar 1, 2015

Anticipated Study Completion Date :

Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Unidad de Uroginecologia, Complejo Asistencial Dr. Sotero del Rio	Santiago	Region Metropolitana	Chile	8207257

Sponsors and Collaborators

Servicio de Salud Metropolitano Sur Oriente
Pontificia Universidad Catolica de Chile

Investigators

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