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

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: Completed
• Conditions: Pelvic Organ Prolapse; Vaginal Prolapse
• Intervention / Treatment: Device: Volumetric Cross-Shaped Vaginal Pessary

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: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Pelvic Floor Distress Inventory-20 Score at 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

Outcome Measure	Measure Description	Time Frame
Device Continuation Rate at 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	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	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	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	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	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	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	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	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

• Sponsor: Dnipro State Medical University
• Investigators: Principal Investigator: Mykhailo V. Medvediev, MD, PhD, DSc, Dnipro State Medical University

Publications and helpful links

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

• International patent application for the volumetric cross-shaped pessary (WO2025159727A1)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Actual): March 31, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: quality of life; pelvic floor disorders; conservative treatment; vaginal pessary; cross-shaped pessary; volumetric pessary
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Male Urogenital Diseases; Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Prolapse; Pathological Conditions, Signs and Symptoms; Pelvic Organ Prolapse; Pelvic Floor Disorders; Uterine Prolapse
• Other Study ID 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