Catheter Related ComplicationNCT06429228
Comparison of 1 Versus 2 Days Post-Operative Catheterization After Anterior Colporrhaphy
A study testing Catheter removal after surgery in people with Catheter Related Complication and Anterior Vaginal Wall Prolapse, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Patients who undergo anterior vaginal wall plastic surgery and place the bladder catheter during surgery are selected. The purpose of the study is to evaluate the presence of statistically significant differences in bladder catheter repositioning within 12 hours after bladder catheter removal in the group of patients… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Catheter Related Complication, Anterior Vaginal Wall Prolapse
- What is being tested?
- Catheter removal after surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 20 Apr 2020to 1 Jan 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women 18 years of age or older
- Patients who are candidates for cystopexy surgery
- Patients who have consented to the signing of the Informed Consent
Who cannot join
- Micturition dysfunction with preoperative bladder stagnation > 200 cc at pessary evaluation
- History of recurrent cystitis
- Positive preoperative urine culture
- Azotemia > 40 mg/dL or creatininemia > 1 mg/dL
- Not collected signed consent endorsed
- Diabetes mellitus
- Contraindications to transurethral bladder catheterization
- Major protocol violations due to unforeseen intraoperative complications (bladder and/or rectal damage, severe bleeding with need for urinary monitoring)
Trial locations and contacts
1 site in 1 country.
About this study
Patients who undergo anterior vaginal wall plastic surgery and place the bladder catheter during surgery are selected. The purpose of the study is to evaluate the presence of statistically significant differences in bladder catheter repositioning within 12 hours after bladder catheter removal in the group of patients in whom the bladder catheter is removed on postoperative day I or II.
Secondary outcomes include evaluation of the incidence of urinary tract infections, number of hospitalization days and total hospitalization costs for patients undergoing anterior vaginal wall surgery in patients in whom the bladder catheter is removed on postoperative day I or II.
- Being tested
- Catheter removal after surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter removal after surgeryProcedure or surgery
Removal of catheter placed during the procedure in first or second post-surgical days.
| Study group | Role | What they receive |
|---|---|---|
| Catheter removal in postoperative day I | Experimental | Not described Receives: Procedure: Catheter removal after surgery |
| Catheter removal in postoperative day II | Experimental | Not described Receives: Procedure: Catheter removal after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
differences in bladder catheter repositioning within 12 hours after bladder catheter removal
After removal of the bladder catheter, on postoperative day I or II, the appearance of urinary urge will be assessed and, in case of spontaneous urination, the quantity of urine will be measured. In the event that after the waiting time of 6 hours an adequate urination stimulus does not arise, we will proceed with an ultrasound evaluation of bladder stagnation (RV) and the application of the department protocol, as follows:
- if the sum of diuresis and RV is between 500 and 1000 cc, extemporaneous catheterization and re-evaluation after 4 hours are indicated
- if the sum of diuresis and RV is > 1000cc, positioning of a bladder catheter and maintenance of the same for 5-7 days with subsequent evaluation is indicated.
Measured: 12 hours
Secondary outcomes (1)
incidence of urinary tract infections for patients undergoing cystopexy surgery in patients in whom the bladder catheter is removed on postoperative day I or II.
Before removing the catheter, a chemical-physical examination will be carried out; if this is positive, urine culture will be carried out. The diagnosis of urinary tract infection will be made with leukocyturia greater than 25 cells per field, positivity for urinary nitrite, presence of at least 20 bacteria per field, bacteriuria and/or more than 100,000 colony forming units associated with at least one of the following signs (fever, dysuria, increased urinary frequency, suprapubic pain, burning on urination or worsening of urinary incontinence). Patients with a positive culture and/or who show symptoms attributable to urinary tract infection will be subjected to antibiotic therapy.
Measured: During hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start20 Apr 2020
- Primary completion18 Apr 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter Related ComplicationStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Salvatore, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429228
- Sponsor's protocol ID
- CAT_273219
- Status last verified
- Jan 2025
- First submitted
- 24 Jan 2024
- Last updated
- 19 Feb 2025
- 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 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 1 Versus 2 Days Post-Operative Catheterization After Anterior Colporrhaphy
- ClinicalTrials.gov ID
- NCT06429228
- Acronym / sponsor ID
- CAT_273219
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 18 Apr 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 24 May 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.
Patients who undergo anterior vaginal wall plastic surgery and place the bladder catheter during surgery are selected. The purpose of the study is to evaluate the presence of statistically significant differences in bladder catheter repositioning within 12 hours after bladder catheter removal in the group of patients in whom the bladder catheter is removed on postoperative day I or II.
Secondary outcomes include evaluation of the incidence of urinary tract infections, number of hospitalization days and total hospitalization costs for patients undergoing anterior vaginal wall surgery in patients in whom the bladder catheter is removed on postoperative day I or II.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter removal in postoperative day I | Experimental | Procedure: Catheter removal after surgery |
| Catheter removal in postoperative day II | Experimental | Procedure: Catheter removal after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women 18 years of age or older
- Patients who are candidates for cystopexy surgery
- Patients who have consented to the signing of the Informed Consent
Key exclusion criteria (8 listed)
- Micturition dysfunction with preoperative bladder stagnation > 200 cc at pessary evaluation
- History of recurrent cystitis
- Positive preoperative urine culture
- Azotemia > 40 mg/dL or creatininemia > 1 mg/dL
- Not collected signed consent endorsed
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 |
|---|---|---|
| Catheter removal after surgeryRemoval of catheter placed during the procedure in first or second post-surgical days. | Procedure or surgery | Catheter removal in postoperative day I, Catheter removal in postoperative day II |
Primary outcome
differences in bladder catheter repositioning within 12 hours after bladder catheter removal
Time frame: 12 hours
After removal of the bladder catheter, on postoperative day I or II, the appearance of urinary urge will be assessed and, in case of spontaneous urination, the quantity of urine will be measured. In the event that after the waiting time of 6 hours an adequate urination stimulus does not arise, we will proceed with an ultrasound evaluation of bladder stagnation (RV) and the application of the department protocol, as follows: * if the sum of diuresis and RV is between 500 and 1000 cc, extemporaneous catheterization and re-evaluation after 4 hours are indicated * if the sum of diuresis and RV is > 1000cc, positioning of a bladder catheter and maintenance of the same for 5-7 days with subsequent evaluation is indicated.
1 secondary outcome
incidence of urinary tract infections for patients undergoing cystopexy surgery in patients in whom the bladder catheter is removed on postoperative day I or II.
Time frame: During hospital stay
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 19 Feb 2025.
- 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.
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 Catheter removal after surgery in people with Catheter Related Complication and Anterior Vaginal Wall Prolapse, run by IRCCS San Raffaele at 1 site in Italy.
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 3 inclusion and 8 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 19 Feb 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 Italy. 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?
differences in bladder catheter repositioning within 12 hours after bladder catheter removal (time frame: 12 hours). 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 19 Feb 2025.