Urinary Retention After ProcedureEarly Phase 1NCT05540977
Donepezil Prevents Urinary Retention After Extensive Total Hysterectomy
A Early Phase 1 study testing Donepezil in people with Urinary Retention After Procedure, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Patients were randomly divided into experimental group and control group. The control group received routine postoperative treatment, while the experimental group took donepezil 5mg orally before going to bed every night from the first day after surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Urinary Retention After Procedure
- What is being tested?
- Donepezil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 15 Jul 2023
- Phase
- Early Phase 1
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- Patients who meet the diagnostic criteria of cervical cancer in the Guidelines for the Diagnosis and Treatment of Cervical Cancer (the Fourth Edition) and have been diagnosed by cervical biopsy or colposcopy
- Patients with surgical indications undergoing extensive abdominal total hysterectomy
- The person who signed the informed consent.
Who cannot join
- Allergic reaction to donepezil hydrochloride, piperidine derivatives or excipients in preparations
- Patients with "sick sinus syndrome" or other supraventricular heart conduction diseases
- Accompanied by serious liver, kidney and other organ dysfunction, serious infectious diseases
- Patients with a history of mental illness and communication disorders
- At the time of inclusion, patients with urinary tract infection had a history of urinary tract diseases (stones, congenital malformations, etc.)
- Patients with intraoperative injury of urinary system, or postoperative ureteral fistula and vesicovaginal fistula.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Qing Chen, Master, 13602826099, sumsqing@139.com
Meimei Guan, Master, 18825135814, 623979652@qq.com
About this study
Official title: Effect of Donepezil on Prevention of Postoperative Urinary Retention in Patients Undergoing Extensive Total Hysterectomy
Patients were randomly divided into experimental group and control group. The control group received routine postoperative treatment, while the experimental group took donepezil 5mg orally before going to bed every night from the first day after surgery. The catheter was removed and residual urine was measured in both groups 14 days after surgery, the catheter was successfully removed when the residual urine was less than 100ml. After 14 days, the patient was returned to the hospital for residual urine test, and the residual urine was repeated until the residual urine volume was less than or equal to 100ml. The incidence of postoperative urinary retention and adverse drug reactions were compared between the two groups.
Read the detailed description
This study hypothesized that donepezil could effectively reduce the incidence of urinary retention in cervical cancer patients after extensive total hysterectomy. A total of 108 patients with cervical cancer who underwent abdominal radical hysterectomy in our department from June 1, 2022 to May 31, 2023 were randomly divided into two groups, the experimental group (n = 54) and the control group (n = 54). The incidence of postoperative urinary retention and adverse drug reactions were compared between the two groups.
- Screening accords with the standard set of subjects, abdominal widely whole palace resection, BiXing random grouping, experimental group from the first day after oral donnelly, pp every night before going to bed together 5 mg, two groups of patients with the rest of the regular place Agreement (including antibiotics to 48 h, postoperative indwelling catheterization, perineum wipe to wash the bid, wound dressing, etc.);
- The catheter was removed and the residual urine was measured 14 days after operation. The residual urine was ≤100ml, and the catheter was successfully removed. The patients in the experimental group stopped taking the drug, and the residual urine was > 100ml.
- Residual urine of patients with urinary retention was measured again 14 days later, and the residual urine was ≤100ml. Patients in the experimental group stopped the drug, and the residual urine was > 100ml. Intermittent catheterization was continued, and patients in the experimental group continued to take the drug until the residual urine volume was ≤100ml.
- This cycle was carried out until the residual urine volume of the last enrolled patient was less than 100ml. The incidence of postoperative urinary retention and adverse drug reactions were compared between the two groups.
- Conditions
- Urinary Retention After Procedure
- Being tested
- Donepezil, Usual care
- Keywords
- Donepezil, Cervical cancer, Urinary Retention
- Medical subject headings
- Uterine Cervical Neoplasms, Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonepezilDrug
Donepezil 5mg QN
Usual careOther
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Donepezil | Experimental | Patients were randomly divided into experimental group and control group. The experimental group received routine postoperative treatment and took donepezil 5mg orally before going to bed every night from the first day after surgery. Receives: Drug: Donepezil |
| Usual care | Other | Usual care Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of urinary retention (residual urine volume < 100ml)
Residual urine volume
Measured: No more than 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start1 Aug 2022
- Primary completion31 May 2023 (estimated)
- Study completion15 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Retention After ProcedureStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540977
- Sponsor's protocol ID
- SYSKY-2022-111-03
- Status last verified
- Jul 2022
- First submitted
- 9 Sep 2022
- Last updated
- 15 Sep 2022
- Results posted
- 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 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Donepezil on Prevention of Postoperative Urinary Retention in Patients Undergoing Extensive Total Hysterectomy
- ClinicalTrials.gov ID
- NCT05540977
- Acronym / sponsor ID
- SYSKY-2022-111-03
- Conditions
- Urinary Retention After Procedure
- Keywords
- Donepezil, Cervical cancer, Urinary Retention
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 15 Jul 2023 (estimated)
- First posted
- 15 Sep 2022 (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.
Patients were randomly divided into experimental group and control group. The control group received routine postoperative treatment, while the experimental group took donepezil 5mg orally before going to bed every night from the first day after surgery. The catheter was removed and residual urine was measured in both groups 14 days after surgery, the catheter was successfully removed when the residual urine was less than 100ml. After 14 days, the patient was returned to the hospital for residual urine test, and the residual urine was repeated until the residual urine volume was less than or equal to 100ml. The incidence of postoperative urinary retention and adverse drug reactions were compared between the two groups.
Detailed description
This study hypothesized that donepezil could effectively reduce the incidence of urinary retention in cervical cancer patients after extensive total hysterectomy. A total of 108 patients with cervical cancer who underwent abdominal radical hysterectomy in our department from June 1, 2022 to May 31, 2023 were randomly divided into two groups, the experimental group (n = 54) and the control group (n = 54). The incidence of postoperative urinary retention and adverse drug reactions were compared between the two groups.
- Screening accords with the standard set of subjects, abdominal widely whole palace resection, BiXing random grouping, experimental group from the first day after oral donnelly, pp every night before going to bed together 5 mg, two groups of patients with the rest of the regular place Agreement (including antibiotics to 48 h, postoperative indwelling catheterization, perineum wipe to wash the bid, wound dressing, etc.);
- The catheter was removed and the residual urine was measured 14 days after operation. The residual urine was ≤100ml, and the catheter was successfully removed. The patients in the experimental group stopped taking the drug, and the residual urine was > 100ml.
- Residual urine of patients with urinary retention was measured again 14 days later, and the residual urine was ≤100ml. Patients in the experimental group stopped the drug, and the residual urine was > 100ml. Intermittent catheterization was continued, and patients in the experimental group continued to take the drug until the residual urine volume was ≤100ml.
- This cycle was carried out until the residual urine volume of the last enrolled patient was less than 100ml. The incidence of postoperative urinary retention and adverse drug reactions were compared between the two groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donepezil | Experimental | Drug: DonepezilPatients were randomly divided into experimental group and control group. The experimental group received routine postoperative treatment and took donepezil 5mg orally before going to bed every night from the first day after surgery. |
| Usual care | Other | Other: Usual careUsual care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-80 years
- Patients who meet the diagnostic criteria of cervical cancer in the Guidelines for the Diagnosis and Treatment of Cervical Cancer (the Fourth Edition) and have been diagnosed by cervical biopsy or colposcopy
- Patients with surgical indications undergoing extensive abdominal total hysterectomy
- The person who signed the informed consent.
Key exclusion criteria (6 listed)
- Allergic reaction to donepezil hydrochloride, piperidine derivatives or excipients in preparations
- Patients with "sick sinus syndrome" or other supraventricular heart conduction diseases
- Accompanied by serious liver, kidney and other organ dysfunction, serious infectious diseases
- Patients with a history of mental illness and communication disorders
- At the time of inclusion, patients with urinary tract infection had a history of urinary tract diseases (stones, congenital malformations, etc.)
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 |
|---|---|---|
| DonepezilDonepezil 5mg QN | Drug | Donepezil |
| Usual careUsual care | Other | Usual care |
Primary outcome
The incidence of urinary retention (residual urine volume < 100ml)
Time frame: No more than 6 weeks
Residual urine volume
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- 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 Early Phase 1 study testing Donepezil in people with Urinary Retention After Procedure, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 6 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 15 Sep 2022. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Qing Chen, MD (+8613602826099, sumsqing@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of urinary retention (residual urine volume < 100ml) (time frame: No more than 6 weeks). 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 15 Sep 2022.