NCT06639217

Brief Summary

Pelvic organ prolapse is the descent of pelvic structures into the vagina due to ligament or muscular weakness. Pelvic organ prolapse (POP) is subcategorized according to the compartment of descent. Cystocele characterizes anterior wall herniation, rectocele refers to the posterior vaginal wall descent, and vaginal vault prolapse characterizes the descent of the uterus, cervix, or apex of the vagina. They can occur either singly or in combination

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

October 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2025

Completed
Last Updated

August 5, 2025

Status Verified

November 1, 2024

Enrollment Period

10 months

First QC Date

October 10, 2024

Last Update Submit

August 4, 2025

Conditions

Keywords

women prolapse -Care Protocol

Outcome Measures

Primary Outcomes (2)

  • Nurses knowledge structured interview

    two main parts. Part I: Lifestyle interventions: This part will be including items related to weight loss, reducing exacerbating activities (e.g. heavy lifting, coughing) and treating constipation, pelvic floor muscle exercises etc.) Part II: pessaries intervention: This part will be including items related to indication of pessaries use, pessary maintenance and follow-up, complications, various types of pessaries, etc.) The scoring system. This tool will be scored on 2 point Likert scale . The researcher will give (1) point for each correct answer and (0) point for each incorrect answer, or don't know. Total knowledge score will be summed, transferred to percent and categorized as follows: * poor (\<50% of the total score) * fair (50-≤80% of the total score) * good (≥80

    3 months

  • Nurses Observational Practices Checklist

    This tool will be scored on 4 point Likert scale for each item as follows: * Done correctly and completely (3) * Done but incompletely (2). * Done incorrectly (1). * Not done (0). The total score for nurses' practices was classified as the following; * A score of more than 75% was considered "Satisfactory nursing practices". * A score of less than 75% was considered "Unsatisfactory nursing practices".

    3 months

Study Arms (1)

a comprehensive nursing care protocol

EXPERIMENTAL

a comprehensive nursing care protocol provided for nurses who provide direct care for women with pelvic organ prolapse and urinary incontinence on their knowledge and practices as well as its impact on the women quality of life

Other: a comprehensive nursing care protocol

Interventions

a comprehensive nursing care protocol provided for nurses who provide direct care for women with pelvic organ prolapse and urinary incontinence on their knowledge and practices as well as its impact on the women quality of life

a comprehensive nursing care protocol

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 20≥ 60 years
  • Willing to participate in the study
  • Both sex

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Basma

Al Mansurah, Al Dakahlia,, 35931, Egypt

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2024

First Posted

October 15, 2024

Study Start

October 10, 2024

Primary Completion

August 2, 2025

Study Completion

August 3, 2025

Last Updated

August 5, 2025

Record last verified: 2024-11

Locations