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Not yet recruiting NCT06432218

Patient Education in the Clinical Management of Pessary

No phase Interventional Pelvic Organ Prolapse

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: video education, conventional education.
Who it may be relevant to
Registry conditions: Pelvic Organ Prolapse. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Randomized Controlled Trial of the Effectiveness of Patient Education in the Clinical Management of Pessary

Overview

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.

Interventions

  • Other video 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.
  • Other conventional education
    Conventional verbal/paper instruction and counseling from a specialized doctor or nurse before pessary fitting.

Primary outcome measures

  • Continued usage with satisfaction [Time frame: 12 months after pessary fitting.]
Secondary outcome measures (8)
  • 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.]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking Union Medical College Hospital — Beijing

Identifiers

NCT: NCT06432218 · K5558

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗