Pelvic Organ ProlapseCROSS-PESNCT07554651
Cross-Shaped Vaginal Pessary for Pelvic Organ Prolapse
A study testing Volumetric Cross-Shaped Vaginal Pessary in people with Pelvic Organ Prolapse and Vaginal Prolapse, run by Dnipro State Medical University at 5 sites in Ukraine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Vaginal Prolapse
- What is being tested?
- Volumetric Cross-Shaped Vaginal Pessary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 5 sitesUkraine
- Study dates
- 1 Sep 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Ukraine5 sites
City Clinical Hospital No. 6, Dnipro City Council
Dnipro
Clinical Hospital of Emergency Medical Care, Dnipro City Council
Dnipro
City Out-Patient Clinic No. 18, Kharkiv City Council
Kharkiv
Regional Clinical Hospital, Poltava Regional Council
Poltava
State Interdistrict Screening Center
Sheptytskyi
About this study
Official 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
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.
Read the 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.
- Conditions
- Pelvic Organ Prolapse, Vaginal Prolapse
- Being tested
- Volumetric Cross-Shaped Vaginal Pessary
- Keywords
- vaginal pessary, pelvic floor disorders, quality of life, conservative treatment, cross-shaped pessary, volumetric pessary
- Medical subject headings
- Pelvic Organ Prolapse, Uterine Prolapse, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Volumetric Cross-Shaped Vaginal Pessary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 3 months
Secondary outcomes (9)
Device Continuation Rate at 6 Months
Proportion of participants continuing use of the cross-shaped vaginal pessary at 6 months.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start1 Sep 2024
- Primary completion31 Mar 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dnipro State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mykhailo Medvediev, Dnipro State Medical University
- Investigators
- Mykhailo V. Medvediev, MD, PhD, DSc, Principal investigator, Dnipro State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554651
- Sponsor's protocol ID
- DSMU-GYN-PES-2024-01
- Acronym
- CROSS-PES
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13. doi: 10.1016/j.ajog.2004.12.025.
PubMed 16021067Bump RC, Mattiasson A, Bo K, Brubaker LP, DeLancey JO, Klarskov P, Shull BL, Smith AR. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol. 1996 Jul;175(1):10-7. doi: 10.1016/s0002-9378(96)70243-0.
PubMed 8694033van der Vaart LR, Vollebregt A, Milani AL, Lagro-Janssen AL, Duijnhoven RG, Roovers JWR, van der Vaart CH. Effect of Pessary vs Surgery on Patient-Reported Improvement in Patients With Symptomatic Pelvic Organ Prolapse: A Randomized Clinical Trial. JAMA. 2022 Dec 20;328(23):2312-2323. doi: 10.1001/jama.2022.22385.
PubMed 36538310Hagen S, Kearney R, Goodman K, Best C, Elders A, Melone L, Dwyer L, Dembinsky M, Graham M, Agur W, Breeman S, Culverhouse J, Forrest A, Forrest M, Guerrero K, Hemming C, Khunda A, Manoukian S, Mason H, McClurg D, Norrie J, Thakar R, Bugge C. Clinical effectiveness of vaginal pessary self-management vs clinic-based care for pelvic organ prolapse (TOPSY): a randomised controlled superiority trial. EClinicalMedicine. 2023 Nov 23;66:102326. doi: 10.1016/j.eclinm.2023.102326. eCollection 2023 Dec.
PubMed 38078194
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07554651
- Acronym / sponsor ID
- CROSS-PES / DSMU-GYN-PES-2024-01
- Conditions
- Pelvic Organ Prolapse, Vaginal Prolapse
- Keywords
- vaginal pessary, pelvic floor disorders, quality of life, conservative treatment, cross-shaped pessary, volumetric pessary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Dnipro State Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cross-Shaped Vaginal Pessary | Experimental | Device: Volumetric Cross-Shaped Vaginal PessaryParticipants with pelvic organ prolapse and prior traditional pessary use are fitted with a volumetric cross-shaped vaginal pessary and followed for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volumetric Cross-Shaped Vaginal PessaryA 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. | Device | Cross-Shaped Vaginal Pessary |
Primary outcome
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.
9 secondary outcomes
Device Continuation Rate at 6 Months
Time frame: 6 months
Change From Baseline in Pelvic Floor Impact Questionnaire-7 Score at 3 and 6 Months
Time frame: Baseline, 3 months, and 6 months
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
Change From Baseline in Baden-Walker Grade at 1, 3, and 6 Months
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
Time frame: Baseline, 1 month, 3 months, and 6 months
Patient Global Impression of Improvement at 3 and 6 Months
Time frame: 3 months and 6 months
Patient Global Impression of Severity at 3 and 6 Months
Time frame: 3 months and 6 months
Patient Preference for Cross-Shaped Pessary at 6 Months
Time frame: 6 months
Incidence of Device-Related Adverse Events Through 6 Months
Time frame: Through 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Background: PubMed 16021067Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13. doi: 10.1016/j.ajog.2004.12.025.
- Background: PubMed 8694033Bump RC, Mattiasson A, Bo K, Brubaker LP, DeLancey JO, Klarskov P, Shull BL, Smith AR. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol. 1996 Jul;175(1):10-7. doi: 10.1016/s0002-9378(96)70243-0.
- Background: PubMed 36538310van der Vaart LR, Vollebregt A, Milani AL, Lagro-Janssen AL, Duijnhoven RG, Roovers JWR, van der Vaart CH. Effect of Pessary vs Surgery on Patient-Reported Improvement in Patients With Symptomatic Pelvic Organ Prolapse: A Randomized Clinical Trial. JAMA. 2022 Dec 20;328(23):2312-2323. doi: 10.1001/jama.2022.22385.
- Background: PubMed 38078194Hagen S, Kearney R, Goodman K, Best C, Elders A, Melone L, Dwyer L, Dembinsky M, Graham M, Agur W, Breeman S, Culverhouse J, Forrest A, Forrest M, Guerrero K, Hemming C, Khunda A, Manoukian S, Mason H, McClurg D, Norrie J, Thakar R, Bugge C. Clinical effectiveness of vaginal pessary self-management vs clinic-based care for pelvic organ prolapse (TOPSY): a randomised controlled superiority trial. EClinicalMedicine. 2023 Nov 23;66:102326. doi: 10.1016/j.eclinm.2023.102326. eCollection 2023 Dec.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mykhailo V. Medvediev, MD, PhD, DSc principal investigator
Dnipro State Medical University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volumetric Cross-Shaped Vaginal Pessary in people with Pelvic Organ Prolapse and Vaginal Prolapse, run by Dnipro State Medical University at 5 sites in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Pelvic Floor Distress Inventory-20 Score at 3 Months (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07554651, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.