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NCT Number: NCT06432218

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location contact

Lan Zhu, MD

PRINCIPAL_INVESTIGATOR

Ying Zhou, MD

CONTACT

[email protected]

+8613681253992

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Video education

Other

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 education

Other

Conventional verbal/paper instruction and counseling from a specialized doctor or nurse before pessary fitting.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Knowledge of pessary

    Time frame: Baseline and at pessary fitting.

    Self-rated score from 0 to 10 points (higher scores mean a better outcome).

  2. Willingness to treatment

    Time frame: Baseline, at pessary fitting, and 3 and 12 months after successful pessary fitting.

    Self-rated score from 0 to 10 points (higher scores mean a better outcome).

  3. Anxiety about pessary use

    Time frame: Baseline and at pessary fitting.

    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).

  4. Ability to self-manage

    Time frame: 3 and 12 months after successful pessary fitting.

    Self-rated score from 0 to 10 points (higher scores mean a better outcome).

  5. Treatment-related symptoms and complications

    Time frame: 3 and 12 months after successful pessary fitting.

    Self report and physical examination.

  6. Improvement in symptoms

    Time frame: 3 and 12 months after successful pessary fitting.

    Pelvic floor impact questionnaire-7 (PFIQ-7) (the range of scores is 0-300, and higher scores mean a worse outcome)

  7. Improvement in quality of life

    Time frame: 3 and 12 months after successful pessary fitting.

    Pelvic floor distress inventory-20 (PFDI-20) (the range of scores is 0-300, and higher scores mean a worse outcome)

  8. Improvement in sexual activity

    Time frame: 3 and 12 months after successful pessary fitting.

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Zhou, MD

CONTACT

[email protected]

+8613681253992

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • Changsha Hospital for Maternal and Child Health Care
  • Foshan Women's and Children's Hospital
  • Hangzhou Women's Hospital
  • Peking University People's Hospital
  • Shandong University
  • Shenzhen People's Hospital
  • Third Military Medical University
  • Tongji Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 29, 2024
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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