## Protocol Section
### Identification Module
**NCT ID:** NCT06432218

**Brief Title:** Patient Education in the Clinical Management of Pessary

**Official Title:** A Randomized Controlled Trial of the Effectiveness of Patient Education in the Clinical Management of Pessary

#### Organization Study ID Info
**ID:** K5558
#### Organization
**Class:** OTHER
**Full Name:** Peking Union Medical College Hospital
### Status Module
#### Completion Date
**Date:** 2026-11

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-11

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Peking University People's Hospital

**Class:** OTHER

**Name:** Shandong University

**Class:** OTHER

**Name:** Tongji Hospital

**Class:** OTHER

**Name:** Third Military Medical University

**Class:** OTHER

**Name:** Changsha Hospital for Maternal and Child Health Care

**Class:** UNKNOWN

**Name:** Hangzhou Women's Hospital

**Class:** OTHER

**Name:** Shenzhen People's Hospital

**Class:** UNKNOWN

**Name:** Foshan Women and Children Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** Peking Union Medical College Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Pelvic Organ Prolapse

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 280

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Watch video as well as receive conventional guidance.

**Intervention Names:**

- Other: video education

- Other: conventional education

**Label:** the conventional education plus video education group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Receive conventional guidance.

**Intervention Names:**

- Other: conventional education

**Label:** the conventional education group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- the conventional education plus video education group

**Description:** 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.

**Name:** video education

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- the conventional education group

- the conventional education plus video education group

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

**Name:** conventional education

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Continued usage of the pessary and have very much or much improvement in the patient impression of improvement (PGI-I) questionnaire at 1 year.

**Measure:** Continued usage with satisfaction

**Time Frame:** 12 months after pessary fitting.

#### Secondary Outcomes

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

**Measure:** Knowledge of pessary

**Time Frame:** Baseline and at pessary fitting.

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

**Measure:** Willingness to treatment

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

**Description:** 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).

**Measure:** Anxiety about pessary use

**Time Frame:** Baseline and at pessary fitting.

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

**Measure:** Ability to self-manage

**Time Frame:** 3 and 12 months after successful pessary fitting.

**Description:** Self report and physical examination.

**Measure:** Treatment-related symptoms and complications

**Time Frame:** 3 and 12 months after successful pessary fitting.

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

**Measure:** Improvement in symptoms

**Time Frame:** 3 and 12 months after successful pessary fitting.

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

**Measure:** Improvement in quality of life

**Time Frame:** 3 and 12 months after successful pessary fitting.

**Description:** 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)

**Measure:** Improvement in sexual activity

**Time Frame:** 3 and 12 months after successful pessary fitting.

### Eligibility Module

**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)

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** shellypumch@163.com

**Name:** Ying Zhou, MD

**Phone:** +8613681253992

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** shellypumch@163.com

- **Name:** Ying Zhou, MD

- **Phone:** +8613681253992

- **Role:** CONTACT

***Contact 2:***

- **Name:** Lan Zhu, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** Peking Union Medical College Hospital

**State:** Beijing

**Zip:** 100730

#### Overall Officials

**Official 1:**

**Affiliation:** Peking Union Medical College Hospital

**Name:** Lan Zhu, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020763

- Term: Pathological Conditions, Anatomical

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14261

- Name: Prolapse

- Relevance: HIGH

- As Found: Prolapse

- ID: M28618

- Name: Pelvic Organ Prolapse

- Relevance: HIGH

- As Found: Pelvic Organ Prolapse

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011391

- Term: Prolapse

- ID: D000056887

- Term: Pelvic Organ Prolapse

### Misc Info Module

- Version Holder: 2024-05-31
