Patient Education in the Clinical Management of Pessary

NCT ID: NCT06432218

Last Updated: 2024-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-30

Study Completion Date

2026-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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the conventional education plus video education group

Watch video as well as receive conventional guidance.

Group Type EXPERIMENTAL

video education

Intervention Type 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

Intervention Type OTHER

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

the conventional education group

Receive conventional guidance.

Group Type ACTIVE_COMPARATOR

conventional education

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

conventional education

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role collaborator

Shandong University

OTHER

Sponsor Role collaborator

Tongji Hospital

OTHER

Sponsor Role collaborator

Third Military Medical University

OTHER

Sponsor Role collaborator

Changsha Hospital for Maternal and Child Health Care

OTHER

Sponsor Role collaborator

Hangzhou Women's Hospital

UNKNOWN

Sponsor Role collaborator

Shenzhen People's Hospital

OTHER

Sponsor Role collaborator

Foshan Women's and Children's Hospital

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lan Zhu, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Ying Zhou, MD

Role: CONTACT

+8613681253992

Facility Contacts

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Ying Zhou, MD

Role: primary

+8613681253992

Other Identifiers

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K5558

Identifier Type: -

Identifier Source: org_study_id

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