Intermittent CatheterizationNCT06529107
Conversion of Evidence and Applied Research on Intermittent Catheterization After Radical Hysterectomy
A study testing intermittent catheterization protocol based on the best evidence in people with Intermittent Catheterization and Conversion of Evidence, run by West China Second University Hospital at 1 site in China.
Trial summary
In this study, the investigators summarize the existing best evidence of intermittent catheterization in patients after radical cervical cancer surgery from the perspective of clinical translation of evidence through systematic search, evaluation and evidence integration, construct a nursing protocol of intermittent… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Intermittent Catheterization, Conversion of Evidence
- What is being tested?
- intermittent catheterization protocol based on the best evidence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2024
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≧ 18 years old
- Radical cervical cancer surgery and intermittent catheterization were performed at the Institute's hospital
- Patients or their family members can operate a smartphone
- No cognitive or psychiatric disorders, and can communicate effectively
Who cannot join
- People with serious heart, brain, lung and other important organ diseases
- People with water, electrolyte, acid-base balance disorders at the beginning of intermittent catheterization
- People with previous serious renal diseases, bladder and urethra surgery
- People with urinary tract infections
- People who did not complete all interventions or data collection
- People who voluntarily withdrew from the study or died during the study period;
- Refuse to participate in this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Second University Hospital, Sichuan University
Chengdu, Sichuan
Lu Xing, +8619827473462, xinglu_0707@163.com
About this study
In this study, the investigators summarize the existing best evidence of intermittent catheterization in patients after radical cervical cancer surgery from the perspective of clinical translation of evidence through systematic search, evaluation and evidence integration, construct a nursing protocol of intermittent catheterization for patients after radical cervical cancer surgery based on the best evidence combined with the clinical context, and explore the clinical application effect of the above nursing protocol. It will provide a reference basis for the development of the standardization and management of intermittent catheterization for postoperative patients with cervical cancer in China, as well as the development of guidelines for intermittent catheterization after radical cervical cancer surgery.
- Being tested
- intermittent catheterization protocol based on the best evidence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittent catheterization protocol based on the best evidenceBehavioural
A best evidence-based protocol for intermittent catheterization after radical cervical cancer surgery
| Study group | Role | What they receive |
|---|---|---|
| A best evidence-based protocol for intermittent catheterization | Experimental | Not described Receives: Behavioral: intermittent catheterization protocol based on the best evidence |
| Routine intermittent catheterization care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of urinary complications
the occurrence of urologic complications within 2 months after discharge of the patients from the hospital for follow-up, which in this study included urinary tract infections, urethral injuries, bladder stones, hydronephrosis
Measured: Within 2 months of discharge
Secondary outcomes (5)
Intermittent Catheterization Compliance Scale
A questionnaire was used to investigate patients' adherence to carrying out intermittent catheterization before the intervention, immediately after the intervention, and 1 month after discharge from the hospital. Higher scores indicate better adherence.
Measured: Pre-intervention, immediately post-intervention, and 1 month post-discharge
12-Item Short Form Survey
A questionnaire was used to investigate patients' quality of life before and immediately after the intervention and 1 month after discharge. Higher scores indicate better quality of life.
Measured: Pre-intervention, immediately post-intervention, and 1 month post-discharge
Self-Rating Anxiety Scale
A questionnaire was used to investigate patients' anxiety before and immediately after the intervention and 1 month after discharge from the hospital. Higher scores indicate greater anxiety.
Measured: Pre-intervention, immediately post-intervention, and 1 month post-discharge
Intermittent Catheterization Confidence Scale
A questionnaire was used to investigate patients' self-efficacy before and immediately after the intervention and 1 month after discharge from the hospital. Higher scores indicate greater confidence.
Measured: Pre-intervention, immediately post-intervention, and 1 month post-discharge
Utilization of health services
Follow-up to record the number of unplanned readmissions, outpatient visits, and emergency room visits within 2 months of discharge and to evaluate the patient's health service utilization
Measured: Within 2 months of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Jan 2024
- Primary completion10 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent CatheterizationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Second University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Xing, West China Second University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529107
- Sponsor's protocol ID
- 2023203
- Status last verified
- Jul 2024
- First submitted
- 20 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conversion of Evidence and Applied Research on Intermittent Catheterization After Radical Hysterectomy
- ClinicalTrials.gov ID
- NCT06529107
- Acronym / sponsor ID
- 2023203
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- West China Second University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 10 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 31 Jul 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.
In this study, the investigators summarize the existing best evidence of intermittent catheterization in patients after radical cervical cancer surgery from the perspective of clinical translation of evidence through systematic search, evaluation and evidence integration, construct a nursing protocol of intermittent catheterization for patients after radical cervical cancer surgery based on the best evidence combined with the clinical context, and explore the clinical application effect of the above nursing protocol. It will provide a reference basis for the development of the standardization and management of intermittent catheterization for postoperative patients with cervical cancer in China, as well as the development of guidelines for intermittent catheterization after radical cervical cancer surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A best evidence-based protocol for intermittent catheterization | Experimental | Behavioral: intermittent catheterization protocol based on the best evidence |
| Routine intermittent catheterization care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≧ 18 years old
- Radical cervical cancer surgery and intermittent catheterization were performed at the Institute's hospital
- Patients or their family members can operate a smartphone
- No cognitive or psychiatric disorders, and can communicate effectively
Key exclusion criteria (7 listed)
- People with serious heart, brain, lung and other important organ diseases
- People with water, electrolyte, acid-base balance disorders at the beginning of intermittent catheterization
- People with previous serious renal diseases, bladder and urethra surgery
- People with urinary tract infections
- People who did not complete all interventions or data collection
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 |
|---|---|---|
| intermittent catheterization protocol based on the best evidenceA best evidence-based protocol for intermittent catheterization after radical cervical cancer surgery | Behavioural | A best evidence-based protocol for intermittent catheterization |
Primary outcome
Incidence of urinary complications
Time frame: Within 2 months of discharge
the occurrence of urologic complications within 2 months after discharge of the patients from the hospital for follow-up, which in this study included urinary tract infections, urethral injuries, bladder stones, hydronephrosis
5 secondary outcomes
Intermittent Catheterization Compliance Scale
Time frame: Pre-intervention, immediately post-intervention, and 1 month post-discharge
12-Item Short Form Survey
Time frame: Pre-intervention, immediately post-intervention, and 1 month post-discharge
Self-Rating Anxiety Scale
Time frame: Pre-intervention, immediately post-intervention, and 1 month post-discharge
Intermittent Catheterization Confidence Scale
Time frame: Pre-intervention, immediately post-intervention, and 1 month post-discharge
Utilization of health services
Time frame: Within 2 months of discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intermittent catheterization protocol based on the best evidence in people with Intermittent Catheterization and Conversion of Evidence, run by West China Second University Hospital at 1 site in China.
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 7 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: status not confirmed, as of the sponsor's last update on 31 Jul 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lu Xing (+8619827473462, xinglu_0707@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of urinary complications (time frame: Within 2 months of discharge). 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 31 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.