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Completed

NCT Number: NCT07554651

Cross-Shaped Vaginal Pessary for Pelvic Organ Prolapse

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.

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Key information

Conditions

Pelvic Organ Prolapse Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Floor Disorders Pregnancy Complications Prolapse Urogenital Diseases Uterine Diseases Uterine Prolapse Vaginal Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

City Clinical Hospital No. 6, Dnipro City Council, Dnipro, Ukraine

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Volumetric Cross-Shaped Vaginal Pessary

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Device Continuation Rate at 6 Months

    Time frame: 6 months

    Proportion of participants continuing use of the cross-shaped vaginal pessary at 6 months.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Dnipro State Medical University

Other

Registry information

Official study title

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

Acronym: CROSS-PES

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 28, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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