Cross-Shaped Vaginal Pessary for Pelvic Organ Prolapse

NCT07554651 | Completed

• 1 other identifier: DSMU-GYN-PES-2024-01
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 5

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.

Conditions

Pelvic Organ Prolapse; Vaginal Prolapse

Keywords

vaginal pessary; pelvic floor disorders; quality of life; conservative treatment; cross-shaped pessary; volumetric pessary

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Device Continuation Rate at 6 Months

  6 months

• Change From Baseline in Pelvic Floor Impact Questionnaire-7 Score at 3 and 6 Months

  Baseline, 3 months, and 6 months

• Change From Baseline in Pelvic Organ Prolapse Quantification Stage at 1, 3, and 6 Months

  Baseline, 1 month, 3 months, and 6 months

• Change From Baseline in Baden-Walker Grade at 1, 3, and 6 Months

  Baseline, 1 month, 3 months, and 6 months

• Change From Baseline in Pain Visual Analogue Scale Score at 1, 3, and 6 Months

  Baseline, 1 month, 3 months, and 6 months

Study Arms (1)

Cross-Shaped Vaginal Pessary

EXPERIMENTAL

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

Interventions

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.

Cross-Shaped Vaginal Pessary

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dnipro State Medical University: lead

Study Sites (5)

City Clinical Hospital No. 6, Dnipro City Council

Dnipro, Ukraine

Location

Clinical Hospital of Emergency Medical Care, Dnipro City Council

Dnipro, Ukraine

Location

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

Kharkiv, Ukraine

Location

Regional Clinical Hospital, Poltava Regional Council

Poltava, Ukraine

Location

State Interdistrict Screening Center

Sheptytskyi, Ukraine

Location

Related Publications (4)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse; Uterine Prolapse; Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Officials

• Mykhailo V. Medvediev, MD, PhD, DSc

  Dnipro State Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking was used because the investigational pessary is visibly and physically distinct from traditional vaginal pessary types.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head, Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start: September 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: June 30, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

UA (5)