An interventional study of video education and conventional education in Pelvic Organ Prolapse, sponsored by Peking Union Medical College Hospital. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Treatment
Among 12 studies in Pelvic Organ Prolapse by Peking Union Medical College Hospital — 3 open to participants now, 3 under way, none of them phase 3. Pelvic Organ Prolapse · Peking Union Medical College Hospital.
Among the 12 studies in Pelvic Organ Prolapse by Peking Union Medical College Hospital, this one is the only one that started in 2024, is one of 8 with no phase, and was the 12th registered.
521 studies on the registry are indexed under Pelvic Organ Prolapse; 80 are open to participants now.
Browse Pelvic Organ Prolapse studies →3 of the 12 studies in Pelvic Organ Prolapse by Peking Union Medical College Hospital are open now, in 1 country. Recruiting first, the newest first:
Peking Union Medical College Hospital · Sites in China
Ages 53–75 · Women only
Peking Union Medical College Hospital · Sites in China
Ages 18+ · Women only
By country, each count listing its studies:
Of the 53 Pelvic Organ Prolapse studies recruiting now, 31 (58%) set no upper age limit and 10 (19%) stop at 75 or younger; 2 take children under 18; 14 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 1 started in 2024.
This study's planned enrollment of 280 is above the median of 80 across 336 interventional studies indexed under Pelvic Organ Prolapse.
Median enrollment 173 across the 8 interventional studies, 933 across the 4 observational. Of the 1 that completed or were terminated, 0 (0%) have results posted.
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Peking Union Medical College Hospital is the lead sponsor of 1,155 studies on the registry; 475 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
1 of the studies in Pelvic Organ Prolapse by Peking Union Medical College Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06432218Peking Union Medical College HospitalPatient Education in the Clinical Management of Pessary | 2026-11 |
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Among the 12 studies in Pelvic Organ Prolapse by Peking Union Medical College Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Watch video as well as receive conventional guidance.
Other: video education · Other: conventional education
Receive conventional guidance.
Other: conventional education
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 verbal/paper instruction and counseling from a specialized doctor or nurse before pessary fitting.
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.
Time frame: 12 months after pessary fitting.
Knowledge of pessary
Self-rated score from 0 to 10 points (higher scores mean a better outcome).
Time frame: Baseline and at pessary fitting.
Willingness to treatment
Self-rated score from 0 to 10 points (higher scores mean a better outcome).
Time frame: 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).
Time frame: Baseline and at pessary fitting.
Ability to self-manage
Self-rated score from 0 to 10 points (higher scores mean a better outcome).
Time frame: 3 and 12 months after successful pessary fitting.
Treatment-related symptoms and complications
Self report and physical examination.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 3 and 12 months after successful pessary fitting.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2024; primary completion for Nov 2026, 29 months later.
Of 162 non-industry interventional studies with no phase under Pelvic Organ Prolapse, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's planned 29 months is above that.
Counting every sponsor, half of 179 studies reached it within 23 months; a quarter within 12 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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