Cross-Shaped Vaginal Pessary for Pelvic Organ Prolapse

Dnipro State Medical University51 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pelvic Organ Prolapse Vaginal Prolapse

Interventions

Volumetric Cross-Shaped Vaginal PessaryDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

City Clinical Hospital No. 6, Dnipro City Council

Dnipro, Ukraine

Clinical Hospital of Emergency Medical Care, Dnipro City Council

Dnipro, Ukraine

City Out-Patient Clinic No. 18, Kharkiv City Council

Kharkiv, Ukraine

Regional Clinical Hospital, Poltava Regional Council

Poltava, Ukraine

Outcomes

Primary Outcomes

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.

Time frame: Baseline and 3 months

Secondary Outcomes

Device Continuation Rate at 6 Months

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline, 1 month, 3 months, and 6 months

Data from ClinicalTrials.gov

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