Cross-Shaped Vaginal Pessary for Pelvic Organ Prolapse (CROSS-PES)

April 29, 2026 updated by: Mykhailo Medvediev, Dnipro State Medical University

Effectiveness and Safety of a Novel Volumetric Cross-Shaped Vaginal Pessary for the Management of Pelvic Organ Prolapse: A Prospective Multicenter Within-Subject Comparison Study

This prospective multicenter single-arm study evaluates the effectiveness and safety of a novel volumetric cross-shaped vaginal pessary in women with pelvic organ prolapse who had prior experience using a traditional vaginal pessary. Each participant serves as her own control by comparing outcomes after fitting of the cross-shaped pessary with documented baseline outcomes during prior traditional pessary use.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Women aged 18 years and older with pelvic organ prolapse stage II or higher and at least 12 weeks of prior traditional pessary use were enrolled at five Ukrainian medical centers. At baseline, the previous pessary was replaced with a volumetric cross-shaped vaginal pessary made of medical-grade silicone. Follow-up assessments were performed at approximately 1 month, 3 months, and 6 months. Assessments included pelvic organ prolapse quantification, Baden-Walker grading, Pelvic Floor Distress Inventory-20, Pelvic Floor Impact Questionnaire-7, pain by visual analogue scale, Patient Global Impression measures, continuation status, patient preference, and adverse events.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ukraine
      • Dnipro, Ukraine
        • City Clinical Hospital No. 6, Dnipro City Council
      • Dnipro, Ukraine
        • Clinical Hospital of Emergency Medical Care, Dnipro City Council
      • Kharkiv, Ukraine
        • City Out-Patient Clinic No. 18, Kharkiv City Council
      • Poltava, Ukraine
        • Regional Clinical Hospital, Poltava Regional Council
      • Sheptytskyi, Ukraine
        • State Interdistrict Screening Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female participants aged 18 years or older
  • Pelvic organ prolapse stage II or higher in any compartment
  • Current use of a traditional vaginal pessary for at least 12 consecutive weeks before enrollment
  • Willing and able to provide written informed consent
  • Able to attend scheduled follow-up visits or participate in telephone interviews

Exclusion Criteria:

  • Active vaginal or pelvic infection at enrollment
  • Pregnancy or planned pregnancy during the study period
  • History of pelvic radiation therapy
  • Severe vaginal atrophy with active erosion preventing pessary use
  • Planned surgical treatment for pelvic organ prolapse during the study period
  • Cognitive impairment or psychiatric condition precluding informed consent or protocol compliance
  • Known allergy to silicone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cross-Shaped Vaginal Pessary
Participants with pelvic organ prolapse and prior traditional pessary use are fitted with a volumetric cross-shaped vaginal pessary and followed for 6 months.
Device: Volumetric Cross-Shaped Vaginal Pessary
A medical-grade silicone vaginal pessary consisting of two intersecting closed rings arranged at approximately right angles around a shared center of symmetry, forming a three-dimensional cross-shaped structure intended to provide multi-vector support for pelvic organ prolapse. The pessary is fitted by a trained gynecologist and participants receive standardized instructions for self-removal, reinsertion, and hygiene.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Pelvic Floor Distress Inventory-20 Score at 3 Months
Time Frame: Baseline and 3 months
The Pelvic Floor Distress Inventory-20 is a validated 20-item questionnaire for pelvic floor symptom distress. Scores range from 0 to 300, with higher scores indicating greater symptom distress. Change from baseline to 3 months is analyzed.
Baseline and 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Device Continuation Rate at 6 Months
Time Frame: 6 months
Proportion of participants continuing use of the cross-shaped vaginal pessary at 6 months.
6 months
Change From Baseline in Pelvic Floor Impact Questionnaire-7 Score at 3 and 6 Months
Time Frame: Baseline, 3 months, and 6 months
The Pelvic Floor Impact Questionnaire-7 is a validated 7-item questionnaire assessing the impact of pelvic floor disorders on activities, relationships, and emotions. Scores range from 0 to 300, with higher scores indicating greater impact.
Baseline, 3 months, and 6 months
Change From Baseline in Pelvic Organ Prolapse Quantification Stage at 1, 3, and 6 Months
Time Frame: Baseline, 1 month, 3 months, and 6 months
Pelvic organ prolapse stage is assessed using the Pelvic Organ Prolapse Quantification system.
Baseline, 1 month, 3 months, and 6 months
Change From Baseline in Baden-Walker Grade at 1, 3, and 6 Months
Time Frame: Baseline, 1 month, 3 months, and 6 months
Pelvic organ prolapse grade is assessed using the Baden-Walker grading system.
Baseline, 1 month, 3 months, and 6 months
Change From Baseline in Pain Visual Analogue Scale Score at 1, 3, and 6 Months
Time Frame: Baseline, 1 month, 3 months, and 6 months
Pessary-related discomfort is assessed using a 10-cm visual analogue scale from 0, no pain, to 10, worst imaginable pain.
Baseline, 1 month, 3 months, and 6 months
Patient Global Impression of Improvement at 3 and 6 Months
Time Frame: 3 months and 6 months
Patient Global Impression of Improvement is assessed using a 7-point Likert scale ranging from very much better to very much worse.
3 months and 6 months
Patient Global Impression of Severity at 3 and 6 Months
Time Frame: 3 months and 6 months
Patient Global Impression of Severity is assessed using a 4-point Likert scale from no problems to severe problems.
3 months and 6 months
Patient Preference for Cross-Shaped Pessary at 6 Months
Time Frame: 6 months
Patient preference for the cross-shaped pessary compared with the previous traditional pessary is assessed by structured telephone interview.
6 months
Incidence of Device-Related Adverse Events Through 6 Months
Time Frame: Through 6 months
Adverse events include vaginal discharge, vaginal erosion or abrasion, bleeding, pain, urinary symptoms, pessary expulsion, infection, fistula formation, and other unanticipated events. Events are summarized by type, severity, and relationship to the device.
Through 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dnipro State Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mykhailo V. Medvediev, MD, PhD, DSc, Dnipro State Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders. American Journal of Obstetrics and Gynecology. 2005;193(1):103-113.
  • Bump RC, Mattiasson A, Bo K, et al. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. American Journal of Obstetrics and Gynecology. 1996;175(1):10-17.
  • van der Vaart LR, Vollebregt A, Milani AL, et al. Effect of pessary vs surgery on patient-reported improvement in women with symptomatic pelvic organ prolapse: the PEOPLE randomized clinical trial. JAMA. 2022;328(23):2312-2323.
  • Hagen S, Glazener C, Sinclair L, et al. Clinical effectiveness of vaginal pessary self-management vs clinic-based care for pelvic organ prolapse: the TOPSY randomised controlled superiority trial. EClinicalMedicine. 2023;66:102326.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DSMU-GYN-PES-2024-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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