Clinical trial NCT06432218: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Peking University People's Hospital
name: Shandong University
name: Tongji Hospital
name: Third Military Medical University
name: Changsha Hospital for Maternal and Child Health Care
name: Hangzhou Women's Hospital
name: Shenzhen People's Hospital
name: Foshan Women's and Children's Hospital
First posted: 2024-05-29
Enrollment: 280
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Continued usage with satisfaction
timeFrame: 12 months after pessary fitting.
Secondary outcomes:
measure: Knowledge of pessary
timeFrame: Baseline and at pessary fitting.
measure: Willingness to treatment
timeFrame: Baseline, at pessary fitting, and 3 and 12 months after successful pessary fitting.
measure: Anxiety about pessary use
timeFrame: Baseline and at pessary fitting.
measure: Ability to self-manage
timeFrame: 3 and 12 months after successful pessary fitting.
measure: Treatment-related symptoms and complications
timeFrame: 3 and 12 months after successful pessary fitting.
measure: Improvement in symptoms
timeFrame: 3 and 12 months after successful pessary fitting.
measure: Improvement in quality of life
timeFrame: 3 and 12 months after successful pessary fitting.
measure: Improvement in sexual activity
timeFrame: 3 and 12 months after successful pessary fitting.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lan Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References: