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

NCT02113969 | Unknown

• 1 other identifier: SA12I2153
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

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

Conditions

Pelvic Organ Prolapse; Quality of Life

Keywords

Pelvic Organ Prolapse; Quality of Life; Symptoms; Pessary; Treatment

Outcome Measures

Primary Outcomes (5)

• Quality of Life changes in pessary users for symptomatic Pelvic Organs Prolapse

  At baseline, 6 and 12 month the Chilean Version of the P-QoL survey will be applied to describe the QoL changes

  6 months and 12 months

• Pelvic Floor Disorders symptoms changes in pessary users for symptomatic Pelvic Organs Prolapse

  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

  6 months and 12 months

• Sexual response changes in pessary sexually active women users for symptomatic Pelvic Organs Prolapse

  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

  6 months and 12 months

• Subjective impression of improvement after pessary use for symptomatic Pelvic Organs Prolapse

  At baseline, 6 and 12 month the Patient Global Impression of Improvement (PGI-I) survey will be applied to describe the subjective improvement

  6 months and 12 months

• Successful usage of pessary

  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.

  12 months

Study Arms (1)

Vaginal Pessary

EXPERIMENTAL

Pessary users for at least 12 months

Device: Vaginal Pessary

Interventions

Vaginal Pessary DEVICE

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.

Vaginal Pessary

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic Pelvic Organ Prolapse
• Commitment to attend controls
• Current negative cervical cytology
• Informed consent signed

You may not qualify if:

• Urinary incontinence as the only Pessary Indication
• Vaginal bleeding of undetermined cause
• Unable to return to controls

Sponsors & Collaborators

• Servicio de Salud Metropolitano Sur Oriente: lead
• Pontificia Universidad Catolica de Chile: collaborator

Study Sites (1)

Unidad de Uroginecologia, Complejo Asistencial Dr. Sotero del Rio

Santiago, Santiago Metropolitan, 8207257, Chile

RECRUITING

Related Publications (1)

• Arellano M, Santis-Moya F, Maluenda A, Pattillo A, Blumel B, Pohlhammer D, Gonzalez S, Pizarro-Berdichevsky J. Prevalence of colorectal symptoms and anal incontinence in patients with pelvic organ prolapse attended at an outpatient urogynecology service. Rev Bras Ginecol Obstet. 2024 Mar 15;46:e-rbgo10. doi: 10.61622/rbgo/2024AO10. eCollection 2024.

  PMID: 38765524 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Pessaries

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• Javier Pizarro, MD

  Complejo Asistencial Dr. Sotero del Rio

  PRINCIPAL INVESTIGATOR

• Bernardita Blumel, MD

  Complejo Asistencial Dr. Sotero del Rio

  STUDY DIRECTOR

• Silvana Gonzalez, Midwife

  Complejo Asistencial Dr. Sotero del Rio

  STUDY CHAIR

• Alejandro Pattillo, MD

  H. Dr. Sotero del Rio; Pontificia Universidad Católica de Chile

  STUDY DIRECTOR

Central Study Contacts

Javier Pizarro, MD

CONTACT

216 583-6220; jpizarro@med.puc.cl

Bernardita Blumel, MD

CONTACT

56 9 82328165; bernarditablumel@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2014
• First Posted: April 15, 2014
• Study Start: September 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2016
• Last Updated: November 18, 2014

Record last verified: 2014-11

Locations

CL (1)