Patient Education in the Clinical Management of Pessary

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorPeking Union Medical College Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • video education

    Other intervention

    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 intervention

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

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: the conventional education plus video education groupExperimental treatment 2 interventions
Group B: the conventional education groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

Knowledge of pessary

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

Time frame
Baseline and at pessary fitting.
2

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.
3

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.
4

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.

Other outcomes

Sponsors and contacts

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Peking Union Medical College Hospital

Lead sponsor

Peking University People's Hospital

Collaborator

Shandong University

Collaborator

Tongji Hospital

Collaborator

Third Military Medical University

Collaborator

Changsha Hospital for Maternal and Child Health Care

Collaborator

Hangzhou Women's Hospital

Collaborator

Shenzhen People's Hospital

Collaborator

Foshan Women's and Children's Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: