Pelvic Organ Prolapse, Vaginal Prolapse
Conditions
Keywords
vaginal pessary, pelvic floor disorders, quality of life, conservative treatment, cross-shaped pessary, volumetric pessary
Brief summary
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.
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.
Interventions
DEVICEVolumetric 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.
Sponsors
Dnipro State Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking was used because the investigational pessary is visibly and physically distinct from traditional vaginal pessary types.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pelvic Floor Distress Inventory-20 Score at 3 Months | 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
| Measure | Time frame | Description |
|---|---|---|
| Device Continuation Rate at 6 Months | 6 months | Proportion of participants continuing use of the cross-shaped vaginal pessary at 6 months. |
| Change From Baseline in Pelvic Floor Impact Questionnaire-7 Score at 3 and 6 Months | 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. |
| Change From Baseline in Pelvic Organ Prolapse Quantification Stage at 1, 3, and 6 Months | Baseline, 1 month, 3 months, and 6 months | Pelvic organ prolapse stage is assessed using the Pelvic Organ Prolapse Quantification system. |
| Change From Baseline in Baden-Walker Grade at 1, 3, and 6 Months | Baseline, 1 month, 3 months, and 6 months | Pelvic organ prolapse grade is assessed using the Baden-Walker grading system. |
| Change From Baseline in Pain Visual Analogue Scale Score at 1, 3, and 6 Months | 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. |
| Patient Global Impression of Improvement at 3 and 6 Months | 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. |
| Patient Global Impression of Severity at 3 and 6 Months | 3 months and 6 months | Patient Global Impression of Severity is assessed using a 4-point Likert scale from no problems to severe problems. |
| Patient Preference for Cross-Shaped Pessary at 6 Months | 6 months | Patient preference for the cross-shaped pessary compared with the previous traditional pessary is assessed by structured telephone interview. |
| Incidence of Device-Related Adverse Events Through 6 Months | 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. |
Countries
Ukraine
Contacts
PRINCIPAL_INVESTIGATORMykhailo V. Medvediev, MD, PhD, DSc
Dnipro State Medical University
Outcome results
None listed