Pelvic Organ ProlapseNCT02113969
Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol
A study testing Vaginal Pessary in people with Pelvic Organ Prolapse and Quality of Life, run by Servicio de Salud Metropolitano Sur Oriente at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Quality of Life
- What is being tested?
- Vaginal Pessary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 1 siteChile
- Study dates
- Sep 2013to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic Pelvic Organ Prolapse
- Commitment to attend controls
- Current negative cervical cytology
- Informed consent signed
Who cannot join
- Urinary incontinence as the only Pessary Indication
- Vaginal bleeding of undetermined cause
- Unable to return to controls
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Unidad de Uroginecologia, Complejo Asistencial Dr. Sotero del Rio
Santiago, Santiago Metropolitan, 8207257
Javier Pizarro, MD, 216-583-6220, jpizarro@med.puc.cl
Bernardita Blumel, MD, 56 9 8232 8165, bernarditablumel@gmail.com
About this study
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.
Read more
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
- Being tested
- Vaginal Pessary
- Keywords
- Pelvic Organ Prolapse, Quality of Life, Symptoms, Pessary, Treatment
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal PessaryDevice
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 group | Role | What they receive |
|---|---|---|
| Vaginal Pessary | Experimental | Pessary users for at least 12 months Receives: Device: Vaginal Pessary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startSep 2013
- Primary completionMar 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Servicio de Salud Metropolitano Sur Oriente
- Sponsor type
- Other government
- Collaborators
- Pontificia Universidad Catolica de Chile
- Responsible party
- Sponsor
- Investigators
- Javier Pizarro, MD, Principal investigator, Complejo Asistencial Dr. Sotero del RioBernardita Blumel, MD, Study director, Complejo Asistencial Dr. Sotero del RioSilvana Gonzalez, Midwife, Study chair, Complejo Asistencial Dr. Sotero del RioAlejandro Pattillo, MD, Study director, H. Dr. Sotero del Rio; Pontificia Universidad Católica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113969
- Sponsor's protocol ID
- SA12I2153
- Status last verified
- Nov 2014
- First submitted
- 9 Apr 2014
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38765524
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol
- ClinicalTrials.gov ID
- NCT02113969
- Acronym / sponsor ID
- SA12I2153
- Conditions
- Pelvic Organ Prolapse, Quality of Life
- Keywords
- Pelvic Organ Prolapse, Quality of Life, Symptoms, Pessary, Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Servicio de Salud Metropolitano Sur OrienteOther government
- Collaborators
- Pontificia Universidad Catolica de Chile
- Study start
- Sep 2013
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 15 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaginal Pessary | Experimental | Device: Vaginal PessaryPessary users for at least 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptomatic Pelvic Organ Prolapse
- Commitment to attend controls
- Current negative cervical cytology
- Informed consent signed
Key exclusion criteria (3 listed)
- Urinary incontinence as the only Pessary Indication
- Vaginal bleeding of undetermined cause
- Unable to return to controls
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal PessaryPessary 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. | Device | Vaginal Pessary |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
- Derived from this study: PubMed 38765524Arellano 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Pizarro, MD principal investigator
Complejo Asistencial Dr. Sotero del Rio
Bernardita Blumel, MD study director
Complejo Asistencial Dr. Sotero del Rio
Silvana Gonzalez, Midwife study chair
Complejo Asistencial Dr. Sotero del Rio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal Pessary in people with Pelvic Organ Prolapse and Quality of Life, run by Servicio de Salud Metropolitano Sur Oriente at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Javier Pizarro, MD (216 583-6220, jpizarro@med.puc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life changes in pessary users for symptomatic Pelvic Organs Prolapse (time frame: 6 months and 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02113969, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2014.