ComplicationNCT05221944
Perioperative Safety of Bladder Hydrodistension in Patients on Antithrombotic Therapy
An observational study of Complication, run by West China Hospital at 1 site in China.
Trial summary
After obtaining an institutional ethics approval (#2019186), we retrospectively reviewed patients with interstitial cystitis/bladder pain syndrome (IC/BPS) who underwent hydrodistension in our hospital during January 2010 and May 2021. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication
- What is being tested?
- Patients had a history of antithrombotic therapy and Patients had no history of antithrombotic therapy
- How many people
- 387 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2019to 10 Apr 2024
- Phase
- Observational
- 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
- All sexes
- Adult, Older adult
Study population: After obtaining an institutional ethics approval (#2019186), we retrospectively reviewed patients with IC/BPS who underwent hydrodistension in our hospital during January 2010 and May 2021. The diagnosis of IC/BPS was made by the same senior urologist according to the National Institute of Diabetes, Digestive and Kidney Diseases guidelines. A stepwise procedure of elimination of disorders with similar symptoms was performed. Patients who met the inclusion and exclusion criteria were considered eligible for the study. Medical records were reviewed to extract baseline information, including age, body mass index (BMI), duration, antithrombotic use and classification, symptom assessment, and perioperative parameters. Patients were then contacted and volunteered to undergo a follow-up.
Who may be able to join
- Over 18 years old when signing an informed consent;
- Previously diagnosed with IC/BPS for a duration of > 6 months;
- O'Leary-Sant Interstitial Cystitis Symptom and Problem Index scores over 18;
- Undergoing hydrodistension during the hospitalization;
- Patients with adequate medical records.
Who cannot join
- General conditions 1) Currently diagnosed with cancer, or have previous history of cancer within the preceding 5 years; 2) Currently diagnosed with severe heart, lung, liver, kidney, or blood disorders; 3) Pregnant women.
- Urological symptoms 1) Have previous history of urinary infection (e.g., bacterial cystitis, bladder tuberculosis, urethritis, genital chlamydia infection, and genital herpes) within 12 weeks; 2) Currently diagnosed with any of following diseases, which had similar symptoms with IC/BPS.
- Bladder diseases (carcinoma, overactive bladder, neurogenic bladder, bladder stone, radiation cystitis)
- Urethral diseases (urethral diverticulum, urethral stricture, urethral stone)
- Gynaecological diseases (endometriosis, uterine fibroids, vaginitis, menopausal syndrome, pelvic organ prolapse)
- Others (neurogenic urinary frequency, polyuria) 3) Have previous history of augmentation cystoplasty or cystectomy; 4) Have previous history of chemical compound (such as cyclophosphamide) derived cystitis.
- Treatment related 1) History of the following therapies within 12 weeks: hydrodistension, intravesical laser therapy, intravesical electrical coagulation, transurethral resection, pelvic reconstructive surgery, nerve stimulation for pain relief; 2) Received intravesical instillation of any drugs within 12 weeks.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan, 610041
Liao Peng, M.D., 18380453539, 602744188@qq.com
About this study
After obtaining an institutional ethics approval (#2019186), we retrospectively reviewed patients with interstitial cystitis/bladder pain syndrome (IC/BPS) who underwent hydrodistension in our hospital during January 2010 and May 2021. The diagnosis of IC/BPS was made by the same senior urologist according to the National Institute of Diabetes, Digestive and Kidney Diseases guidelines. Patients who met the inclusion and exclusion criteria were considered eligible for the study. Medical records were reviewed to extract baseline information, including age, body mass index (BMI), duration, antithrombotic use and classification, symptom assessment, and perioperative parameters. Patients were then contacted and volunteered to undergo a follow-up. Telemedicine-based follow-ups were performed at 3 after surgery. Complications and symptoms were recroded. Then, perioperative parameters, including operation time, hospital stays, catheterization time, and hematological results (hemoglobin, platelet count, and coagulated parameters) were recorded based on medical records. The data were analyzed to investigate if perioperative complications were more common in patients with IC/BPS on antithrombotic therapy after bladder hydrodistension.
Read the detailed description
Study population. This retrospective study was performed in line with STROCSS guidelines. After obtaining an institutional ethics approval (#2019186), we retrospectively reviewed patients with IC/BPS who underwent hydrodistension in our hospital during January 2010 and May 2021. The diagnosis of IC/BPS was made by the same senior urologist according to the National Institute of Diabetes, Digestive and Kidney Diseases guidelines. A stepwise procedure of elimination of disorders with similar symptoms was performed. Generally, urinalysis and urine culture were performed to exclude UTI and some specific infections, ultrasound and imaging were conducted to exclude malformation, carcinoma and urinary stones, and urodynamic studies were performed to assess functional disorders. Patients who met the inclusion and exclusion criteria were considered eligible for the study. Medical records were reviewed to extract baseline information, including age, body mass index (BMI), duration, antithrombotic use and classification, symptom assessment, and perioperative parameters. Patients were then contacted and volunteered to undergo a follow-up.
Antithrombotic therapy. Antithrombotic drugs in the current study included anticoagulation (heparin, warfarin, as well as rivaroxaban) and antiplatelet drugs (aspirin, clopidogrel). The study aimed to investigate if perioperative bleeding complications were more common in patients on antithrombotic therapy. The algorithm of managing antithrombotic use is based on clinical practice. After a cardiologic and anesthetic consultation, patients taking aspirin remained on therapy throughout the procedure and after the procedure. Clopidogrel was held 5 days before hydrodistension and was restarted 24 hours postoperatively. Both low molecular weight heparin (LMWH) and rivaroxaban were discontinued 1 day before surgery and were restarted one day postoperatively. Warfarin was held 5 days before hydrodistension and was restarted 12 hours postoperatively, keeping an international normalized ratio (INR) 2-3.
Bladder hydrodistension. All patients signed informed consents. Patients' basic conditions were carefully evaluated and managed before surgery. The hydrodistension was in a day-surgery setting in our institute and was performed by the same urologist or under his supervision. Broad spectrum antibiotics were given 30 minutes preoperatively. After general anesthesia, Hunner lesions were identified by cystoscopy with the bladder slightly filled with saline. Then, the bladder was distended with normal saline at the pressure of 70 cmH2O for 2 minutes. Under this circumstance, a waterfall bleeding sign from Hunner lesion or glomerulations in submucosa might be visualized. Subsequently, biopsy was performed to exclude carcinomas in situ. At last, a 16 Fr three-way catheter was inserted with continuous saline irrigation. The time to remove catheters and the time to discharge after voiding tests were decided by the treating physician. Intravesical instillation of hyaluronic acid was performed as a follow-up treatment for all patients according to the instructions. Telemedicine-based follow-ups were performed at 3 months after surgery. Perioperative parameters, including operation time, hospital stays, catheterization time, and hematological results (hemoglobin, platelet count, and coagulated parameters) were recorded.
Outcomes. Primary outcomes were complications that were defined by Clavien-Dindo classification of surgical complications. The complications were recoded within 3 months after surgery. Then, the mean frequency of voids per day, number of night urination, O'Leary-Sant Interstitial Cystitis Symptom index (ICSI), O'Leary-Sant Interstitial Cystitis Problem Index (ICPI), and 10-point visual analog scale (VAS) 3 months postoperatively were analyzed to evaluate the improvement of symptoms.
Data analysis. SPSS software (version 25) and GraphPad Prism software (version 8.0) were applied to perform all statistical analyses. Continuous variables are presented as the means ± standard deviation or medians (range), and differences between groups were tested using the Student's t test or the Mann-Whitney U test, respectively. The changes of pre- and postoperative continuous variables were tested by the paired t test. Categorical parameters were reported as the numbers (percentage), and the chi-square test with and without Yates' correction was applied where appropriate. Subsequently, odd ratio (OR) and 95% confidence interval of each adverse event after antithrombotic use were calculated. A p value of < 0.05 was considered statistically significant.
- Conditions
- Complication
- Being tested
- Patients had a history of antithrombotic therapy, Patients had no history of antithrombotic therapy
- Keywords
- Interstitial cystitis, Antithrombotic therapy, Complication, Bladder hydrodistension
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients had a history of antithrombotic therapyOther
Patients with antithrombotic drugs were identified and grouped and their medical records were reviewed.
Patients had no history of antithrombotic therapyOther
Patients had no history of antithrombotic therapy
| Study group | Role | What they receive |
|---|---|---|
| Patients on antithrombotic therapy | The study aimed to investigate if perioperative bleeding complications were more common in patients on antithrombotic therapy. We retrospectively reviewed patients with IC/BPS who underwent hydrodistension during January 2010 and May 2021. Patients with and without antithrombotic drugs were identified and grouped and their medical records were reviewed. Receives: Other: Patients had a history of antithrombotic therapy | |
| Patients without antithrombotic therapy | Patients without antithrombotic drugs were identified as controls Receives: Other: Patients had no history of antithrombotic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Primary outcomes were complications that were defined by Clavien-Dindo classification of surgical complications.
Measured: The complications were recoded within 3 months after surgery.
Secondary outcomes (5)
The mean frequency of voids per day
Change from baseline voids at 3 months.
Measured: The data were recoded at 3 months after surgery.
The mean number of night urination
Change from baseline night urination at 3 months.
Measured: The data were recoded at 3 months after surgery.
O'Leary-Sant Interstitial Cystitis Symptom index (0-19). Higher scores mean a worse outcome.
Change from baseline symptom index at 3 months.
Measured: The data were recoded at 3 months after surgery.
O'Leary-Sant Interstitial Cystitis Problem Index (0-16). Higher scores mean a worse outcome.
Change from baseline problem index at 3 months.
Measured: The data were recoded at 3 months after surgery.
Visual analog scale (0-10). Higher scores mean a worse outcome.
Change from baseline pain index at 3 months.
Measured: The data were recoded at 3 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start4 Jul 2019
- Primary completion10 Feb 2024 (estimated)
- Study completion10 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComplicationStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 387 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, De-yi Luo, West China Hospital
- Investigators
- Wei-min Li, PhD., Study chair, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221944
- Sponsor's protocol ID
- 2019186
- Status last verified
- Sep 2023
- First submitted
- 4 Jan 2022
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Safety of Bladder Hydrodistension in Patients on Antithrombotic Therapy
- ClinicalTrials.gov ID
- NCT05221944
- Acronym / sponsor ID
- 2019186
- Conditions
- Complication
- Keywords
- Interstitial cystitis, Antithrombotic therapy, Complication, Bladder hydrodistension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 387 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 10 Feb 2024 (estimated)
- Study completion
- 10 Apr 2024 (estimated)
- First posted
- 3 Feb 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.
After obtaining an institutional ethics approval (#2019186), we retrospectively reviewed patients with interstitial cystitis/bladder pain syndrome (IC/BPS) who underwent hydrodistension in our hospital during January 2010 and May 2021. The diagnosis of IC/BPS was made by the same senior urologist according to the National Institute of Diabetes, Digestive and Kidney Diseases guidelines. Patients who met the inclusion and exclusion criteria were considered eligible for the study. Medical records were reviewed to extract baseline information, including age, body mass index (BMI), duration, antithrombotic use and classification, symptom assessment, and perioperative parameters. Patients were then contacted and volunteered to undergo a follow-up. Telemedicine-based follow-ups were performed at 3 after surgery. Complications and symptoms were recroded. Then, perioperative parameters, including operation time, hospital stays, catheterization time, and hematological results (hemoglobin, platelet count, and coagulated parameters) were recorded based on medical records. The data were analyzed to investigate if perioperative complications were more common in patients with IC/BPS on antithrombotic therapy after bladder hydrodistension.
Detailed description
Study population. This retrospective study was performed in line with STROCSS guidelines. After obtaining an institutional ethics approval (#2019186), we retrospectively reviewed patients with IC/BPS who underwent hydrodistension in our hospital during January 2010 and May 2021. The diagnosis of IC/BPS was made by the same senior urologist according to the National Institute of Diabetes, Digestive and Kidney Diseases guidelines. A stepwise procedure of elimination of disorders with similar symptoms was performed. Generally, urinalysis and urine culture were performed to exclude UTI and some specific infections, ultrasound and imaging were conducted to exclude malformation, carcinoma and urinary stones, and urodynamic studies were performed to assess functional disorders. Patients who met the inclusion and exclusion criteria were considered eligible for the study. Medical records were reviewed to extract baseline information, including age, body mass index (BMI), duration, antithrombotic use and classification, symptom assessment, and perioperative parameters. Patients were then contacted and volunteered to undergo a follow-up.
Antithrombotic therapy. Antithrombotic drugs in the current study included anticoagulation (heparin, warfarin, as well as rivaroxaban) and antiplatelet drugs (aspirin, clopidogrel). The study aimed to investigate if perioperative bleeding complications were more common in patients on antithrombotic therapy. The algorithm of managing antithrombotic use is based on clinical practice. After a cardiologic and anesthetic consultation, patients taking aspirin remained on therapy throughout the procedure and after the procedure. Clopidogrel was held 5 days before hydrodistension and was restarted 24 hours postoperatively. Both low molecular weight heparin (LMWH) and rivaroxaban were discontinued 1 day before surgery and were restarted one day postoperatively. Warfarin was held 5 days before hydrodistension and was restarted 12 hours postoperatively, keeping an international normalized ratio (INR) 2-3.
Bladder hydrodistension. All patients signed informed consents. Patients' basic conditions were carefully evaluated and managed before surgery. The hydrodistension was in a day-surgery setting in our institute and was performed by the same urologist or under his supervision. Broad spectrum antibiotics were given 30 minutes preoperatively. After general anesthesia, Hunner lesions were identified by cystoscopy with the bladder slightly filled with saline. Then, the bladder was distended with normal saline at the pressure of 70 cmH2O for 2 minutes. Under this circumstance, a waterfall bleeding sign from Hunner lesion or glomerulations in submucosa might be visualized. Subsequently, biopsy was performed to exclude carcinomas in situ. At last, a 16 Fr three-way catheter was inserted with continuous saline irrigation. The time to remove catheters and the time to discharge after voiding tests were decided by the treating physician. Intravesical instillation of hyaluronic acid was performed as a follow-up treatment for all patients according to the instructions. Telemedicine-based follow-ups were performed at 3 months after surgery. Perioperative parameters, including operation time, hospital stays, catheterization time, and hematological results (hemoglobin, platelet count, and coagulated parameters) were recorded.
Outcomes. Primary outcomes were complications that were defined by Clavien-Dindo classification of surgical complications. The complications were recoded within 3 months after surgery. Then, the mean frequency of voids per day, number of night urination, O'Leary-Sant Interstitial Cystitis Symptom index (ICSI), O'Leary-Sant Interstitial Cystitis Problem Index (ICPI), and 10-point visual analog scale (VAS) 3 months postoperatively were analyzed to evaluate the improvement of symptoms.
Data analysis. SPSS software (version 25) and GraphPad Prism software (version 8.0) were applied to perform all statistical analyses. Continuous variables are presented as the means ± standard deviation or medians (range), and differences between groups were tested using the Student's t test or the Mann-Whitney U test, respectively. The changes of pre- and postoperative continuous variables were tested by the paired t test. Categorical parameters were reported as the numbers (percentage), and the chi-square test with and without Yates' correction was applied where appropriate. Subsequently, odd ratio (OR) and 95% confidence interval of each adverse event after antithrombotic use were calculated. A p value of < 0.05 was considered statistically significant.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients on antithrombotic therapy | – | Other: Patients had a history of antithrombotic therapyThe study aimed to investigate if perioperative bleeding complications were more common in patients on antithrombotic therapy. We retrospectively reviewed patients with IC/BPS who underwent hydrodistension during January 2010 and May 2021. Patients with and without antithrombotic drugs were identified and grouped and their medical records were reviewed. |
| Patients without antithrombotic therapy | – | Other: Patients had no history of antithrombotic therapyPatients without antithrombotic drugs were identified as controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- After obtaining an institutional ethics approval (#2019186), we retrospectively reviewed patients with IC/BPS who underwent hydrodistension in our hospital during January 2010 and May 2021. The diagnosis of IC/BPS was made by the same senior urologist according to the National Institute of Diabetes, Digestive and Kidney Diseases guidelines. A stepwise procedure of elimination of disorders with similar symptoms was performed. Patients who met the inclusion and exclusion criteria were considered eligible for the study. Medical records were reviewed to extract baseline information, including age, body mass index (BMI), duration, antithrombotic use and classification, symptom assessment, and perioperative parameters. Patients were then contacted and volunteered to undergo a follow-up.
Key inclusion criteria (5 listed)
- Over 18 years old when signing an informed consent;
- Previously diagnosed with IC/BPS for a duration of > 6 months;
- O'Leary-Sant Interstitial Cystitis Symptom and Problem Index scores over 18;
- Undergoing hydrodistension during the hospitalization;
- Patients with adequate medical records.
Key exclusion criteria (7 listed)
- General conditions 1) Currently diagnosed with cancer, or have previous history of cancer within the preceding 5 years; 2) Currently diagnosed with severe heart, lung, liver, kidney, or blood disorders; 3) Pregnant women.
- Urological symptoms 1) Have previous history of urinary infection (e.g., bacterial cystitis, bladder tuberculosis, urethritis, genital chlamydia infection, and genital herpes) within 12 weeks; 2) Currently diagnosed with any of following diseases, which had similar symptoms with IC/BPS.
- Treatment related 1) History of the following therapies within 12 weeks: hydrodistension, intravesical laser therapy, intravesical electrical coagulation, transurethral resection, pelvic reconstructive surgery, nerve stimulation for pain relief; 2) Received intravesical instillation of any drugs within 12 weeks.
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 |
|---|---|---|
| Patients had a history of antithrombotic therapyPatients with antithrombotic drugs were identified and grouped and their medical records were reviewed. | Other | Patients on antithrombotic therapy |
| Patients had no history of antithrombotic therapyPatients had no history of antithrombotic therapy | Other | Patients without antithrombotic therapy |
Primary outcome
Complications
Time frame: The complications were recoded within 3 months after surgery.
Primary outcomes were complications that were defined by Clavien-Dindo classification of surgical complications.
5 secondary outcomes
The mean frequency of voids per day
Time frame: The data were recoded at 3 months after surgery.
The mean number of night urination
Time frame: The data were recoded at 3 months after surgery.
O'Leary-Sant Interstitial Cystitis Symptom index (0-19). Higher scores mean a worse outcome.
Time frame: The data were recoded at 3 months after surgery.
O'Leary-Sant Interstitial Cystitis Problem Index (0-16). Higher scores mean a worse outcome.
Time frame: The data were recoded at 3 months after surgery.
Visual analog scale (0-10). Higher scores mean a worse outcome.
Time frame: The data were recoded at 3 months after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
Wei-min Li, PhD. study chair
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication, run by West China 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 5 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 15 Sep 2023. 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 Liao Peng, M.D. (18380453539, 602744188@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: The complications were recoded within 3 months after surgery.). 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 2023.