Pelvic Organ ProlapseNurse ProtocolNCT06639217
Comprehensive Nursing Care Protocol for Women With Pelvic Organ Prolapse and Urinary Incontinence: A Global Perspective
A study testing a comprehensive nursing care protocol in people with Pelvic Organ Prolapse, run by Delta University for Science and Technology at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- a comprehensive nursing care protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2024to 3 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All available nurses assigned for bed side care in the previous study settings and fulfilled the following inclusion criteria:
- Age 20≥ 60 years
- Willing to participate in the study
- Both sex
Who cannot join
- nurses did not assign for bed side care in the previous study settings and not fulfill the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
this study aimed to investigate the effectiveness of a comprehensive nursing care protocol provided for nurses who provide direct care for women with pelvic organ prolapse and urinary incontinence in gynecological in patients departments, Mansoura University Hospital, Mansoura University on their knowledge and practices as well as its impact on the women quality of life.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- a comprehensive nursing care protocol
- Keywords
- women prolapse -Care Protocol
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a comprehensive nursing care protocolOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: a comprehensive nursing care protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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".
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start10 Oct 2024
- Primary completion2 Aug 2025
- Study completion3 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639217
- Sponsor's protocol ID
- Women Pelvic Organ Prolapse
- Acronym
- Nurse Protocol
- Status last verified
- Nov 2024
- First submitted
- 10 Oct 2024
- Last updated
- 5 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Nursing Care Protocol for Women With Pelvic Organ Prolapse and Urinary Incontinence: A Global Perspective
- ClinicalTrials.gov ID
- NCT06639217
- Acronym / sponsor ID
- Nurse Protocol / Women Pelvic Organ Prolapse
- Conditions
- Pelvic Organ Prolapse
- Keywords
- women prolapse -Care Protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 2 Aug 2025 (actual)
- Study completion
- 3 Aug 2025 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
this study aimed to investigate the effectiveness of a comprehensive nursing care protocol provided for nurses who provide direct care for women with pelvic organ prolapse and urinary incontinence in gynecological in patients departments, Mansoura University Hospital, Mansoura University on their knowledge and practices as well as its impact on the women quality of life.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| a comprehensive nursing care protocol | Experimental | Other: a comprehensive nursing care protocola 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 |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All available nurses assigned for bed side care in the previous study settings and fulfilled the following inclusion criteria:
Key exclusion criteria (1 listed)
- nurses did not assign for bed side care in the previous study settings and not fulfill the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a comprehensive nursing care protocola 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 |
Primary outcome
Nurses knowledge structured interview
Time frame: 3 months
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
Nurses Observational Practices Checklist
Time frame: 3 months
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".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a comprehensive nursing care protocol in people with Pelvic Organ Prolapse, run by Delta University for Science and Technology at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nurses knowledge structured interview (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.