Pelvic Organ ProlapseNCT06432218
Patient Education in the Clinical Management of Pessary
A study testing video education and conventional education in people with Pelvic Organ Prolapse, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study is a prospective, randomized, controlled, single-blinded, multi-center clinical trial. Symptomatic patients with pelvic organ prolapse (POP) stage II, III or IV arranged to undergo pessary treatment will be randomized into either the experimental group or the control group. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- video education and conventional education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- Jun 2024to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Symptomatic pelvic organ prolapse of stage II~IV
- Ability to participate in clinical trial and follow-up
- The patient and family understand the study, are willing to participate in the 1-year study, and provide written informed consent
Who cannot join
- Acute phase of infection of the internal and/or external genital tracts
- Genital fistula
- Suspected or untreated lower genital tract tumors
- Abnormally elevated intra-abdominal pressure (e.g., ascites, tumors)
- Life expectancy less than 1 year
- Cognitive or language communication disorders
- Unable to watch video (e.g., blindness)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Ying Zhou, MD, +8613681253992, shellypumch@163.com
Lan Zhu, MD
About this study
Official title: A Randomized Controlled Trial of the Effectiveness of Patient Education in the Clinical Management of Pessary
This study is a prospective, randomized, controlled, single-blinded, multi-center clinical trial. Symptomatic patients with pelvic organ prolapse (POP) stage II, III or IV arranged to undergo pessary treatment will be randomized into either the experimental group or the control group. All patients will receive conventional verbal/paper instruction and counseling from a specialized doctor or nurse before pessary fitting, and the experimental group will receive additional patient education in the form of a re-watchable video. The video mainly includes a short introduction of pessary treatment for pelvic organ prolapse, tips and tricks for wearing and self-management of pessary, possible adverse reactions and remedy. All patients will receive regular pessary fitting and be followed up for 1 year. Self-assessment questionnaires will be used to assess the patients' willingness to pessary treatment, anxiety status, treatment satisfaction and efficacy, and to assess the patients' self-management, complications and treatment adherence. Then the differences between the two groups will be compared.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- video education, conventional education
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video educationOther
A re-watchable video provided before pessary fitting which mainly includes a short introduction of pessary treatment for pelvic organ prolapse, tips and tricks for wearing and self-management of pessary, possible adverse reactions and remedy.
conventional educationOther
Conventional verbal/paper instruction and counseling from a specialized doctor or nurse before pessary fitting.
| Study group | Role | What they receive |
|---|---|---|
| the conventional education plus video education group | Experimental | Watch video as well as receive conventional guidance. Receives: Other: video education; Other: conventional education |
| the conventional education group | Active comparator | Receive conventional guidance. Receives: Other: conventional education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continued usage with satisfaction
Continued usage of the pessary and have very much or much improvement in the patient impression of improvement (PGI-I) questionnaire at 1 year.
Measured: 12 months after pessary fitting.
Secondary outcomes (8)
Knowledge of pessary
Self-rated score from 0 to 10 points (higher scores mean a better outcome).
Measured: Baseline and at pessary fitting.
Willingness to treatment
Self-rated score from 0 to 10 points (higher scores mean a better outcome).
Measured: Baseline, at pessary fitting, and 3 and 12 months after successful pessary fitting.
Anxiety about pessary use
7-item generalized anxiety disorder questionnaire (GAD-7) (the range of scores is 0-21, and higher scores mean a worse outcome), and self-rated score of sleep quality from 0 to 10 points (higher scores mean a better outcome).
Measured: Baseline and at pessary fitting.
Ability to self-manage
Self-rated score from 0 to 10 points (higher scores mean a better outcome).
Measured: 3 and 12 months after successful pessary fitting.
Treatment-related symptoms and complications
Self report and physical examination.
Measured: 3 and 12 months after successful pessary fitting.
Improvement in symptoms
Pelvic floor impact questionnaire-7 (PFIQ-7) (the range of scores is 0-300, and higher scores mean a worse outcome)
Measured: 3 and 12 months after successful pessary fitting.
Improvement in quality of life
Pelvic floor distress inventory-20 (PFDI-20) (the range of scores is 0-300, and higher scores mean a worse outcome)
Measured: 3 and 12 months after successful pessary fitting.
Improvement in sexual activity
The pelvic organ prolapse/urinary incontinence sexual questionnaire short form (PISQ-12) (the range of scores is 0-48, and higher scores mean a worse outcome)
Measured: 3 and 12 months after successful pessary fitting.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study startJun 2024 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University People's Hospital, Shandong University, Tongji Hospital, Third Military Medical University, Changsha Hospital for Maternal and Child Health Care, Hangzhou Women's Hospital, Shenzhen People's Hospital, Foshan Women's and Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Lan Zhu, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432218
- Sponsor's protocol ID
- K5558
- Status last verified
- May 2024
- First submitted
- 10 May 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Effectiveness of Patient Education in the Clinical Management of Pessary
- ClinicalTrials.gov ID
- NCT06432218
- Acronym / sponsor ID
- K5558
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Peking University People's Hospital, Shandong University, Tongji Hospital, Third Military Medical University, Changsha Hospital for Maternal and Child Health Care, Hangzhou Women's Hospital, Shenzhen People's Hospital, Foshan Women's and Children's Hospital
- Study start
- Jun 2024 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 29 May 2024 (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 study is a prospective, randomized, controlled, single-blinded, multi-center clinical trial. Symptomatic patients with pelvic organ prolapse (POP) stage II, III or IV arranged to undergo pessary treatment will be randomized into either the experimental group or the control group. All patients will receive conventional verbal/paper instruction and counseling from a specialized doctor or nurse before pessary fitting, and the experimental group will receive additional patient education in the form of a re-watchable video. The video mainly includes a short introduction of pessary treatment for pelvic organ prolapse, tips and tricks for wearing and self-management of pessary, possible adverse reactions and remedy. All patients will receive regular pessary fitting and be followed up for 1 year. Self-assessment questionnaires will be used to assess the patients' willingness to pessary treatment, anxiety status, treatment satisfaction and efficacy, and to assess the patients' self-management, complications and treatment adherence. Then the differences between the two groups will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the conventional education plus video education group | Experimental | Other: video education, Other: conventional educationWatch video as well as receive conventional guidance. |
| the conventional education group | Active comparator | Other: conventional educationReceive conventional guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic pelvic organ prolapse of stage II~IV
- Ability to participate in clinical trial and follow-up
- The patient and family understand the study, are willing to participate in the 1-year study, and provide written informed consent
Key exclusion criteria (7 listed)
- Acute phase of infection of the internal and/or external genital tracts
- Genital fistula
- Suspected or untreated lower genital tract tumors
- Abnormally elevated intra-abdominal pressure (e.g., ascites, tumors)
- Life expectancy less than 1 year
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 |
|---|---|---|
| video educationA re-watchable video provided before pessary fitting which mainly includes a short introduction of pessary treatment for pelvic organ prolapse, tips and tricks for wearing and self-management of pessary, possible adverse reactions and remedy. | Other | the conventional education plus video education group |
| conventional educationConventional verbal/paper instruction and counseling from a specialized doctor or nurse before pessary fitting. | Other | the conventional education group, the conventional education plus video education group |
Primary outcome
Continued usage with satisfaction
Time frame: 12 months after pessary fitting.
Continued usage of the pessary and have very much or much improvement in the patient impression of improvement (PGI-I) questionnaire at 1 year.
8 secondary outcomes
Knowledge of pessary
Time frame: Baseline and at pessary fitting.
Willingness to treatment
Time frame: Baseline, at pessary fitting, and 3 and 12 months after successful pessary fitting.
Anxiety about pessary use
Time frame: Baseline and at pessary fitting.
Ability to self-manage
Time frame: 3 and 12 months after successful pessary fitting.
Treatment-related symptoms and complications
Time frame: 3 and 12 months after successful pessary fitting.
Improvement in symptoms
Time frame: 3 and 12 months after successful pessary fitting.
Improvement in quality of life
Time frame: 3 and 12 months after successful pessary fitting.
Improvement in sexual activity
Time frame: 3 and 12 months after successful pessary fitting.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- 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.
Lan Zhu, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing video education and conventional education in people with Pelvic Organ Prolapse, run by Peking Union Medical College Hospital at 1 site in China.
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 3 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: opening soon, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Zhou, MD (+8613681253992, shellypumch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continued usage with satisfaction (time frame: 12 months after pessary fitting.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2024.