Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 53 of 762 for:    region | Chile

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Collaborator:
Pontificia Universidad Catolica de Chile
Information provided by (Responsible Party):
Servicio de Salud Metropolitano Sur Oriente

Tracking Information
First Submitted Date  ICMJE April 9, 2014
First Posted Date  ICMJE April 15, 2014
Last Update Posted Date November 18, 2014
Study Start Date  ICMJE September 2013
Estimated Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2014)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02113969 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol
Official Title  ICMJE Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pelvic Organ Prolapse
  • Quality of Life
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Vaginal Pessary
Pessary users for at least 12 months
Intervention: Device: Vaginal Pessary
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 10, 2014)
294
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2016
Estimated Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02113969
Other Study ID Numbers  ICMJE SA12I2153
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Servicio de Salud Metropolitano Sur Oriente
Study Sponsor  ICMJE Servicio de Salud Metropolitano Sur Oriente
Collaborators  ICMJE Pontificia Universidad Catolica de Chile
Investigators  ICMJE
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
PRS Account Servicio de Salud Metropolitano Sur Oriente
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP