Perioperative Safety of Bladder Hydrodistension in Patients on Antithrombotic Therapy

NCT05221944 | Unknown DMC

• 1 other identifier: 2019186
• Study Type: observational
• Target: 387
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Complication

Keywords

Interstitial cystitis; Antithrombotic therapy; Complication; Bladder hydrodistension

Outcome Measures

Primary Outcomes (1)

• Complications

  Primary outcomes were complications that were defined by Clavien-Dindo classification of surgical complications.

  The complications were recoded within 3 months after surgery.

Secondary Outcomes (5)

• The mean frequency of voids per day

  The data were recoded at 3 months after surgery.

• The mean number of night urination

  The data were recoded at 3 months after surgery.

• O'Leary-Sant Interstitial Cystitis Symptom index (0-19). Higher scores mean a worse outcome.

  The data were recoded at 3 months after surgery.

• O'Leary-Sant Interstitial Cystitis Problem Index (0-16). Higher scores mean a worse outcome.

  The data were recoded at 3 months after surgery.

• Visual analog scale (0-10). Higher scores mean a worse outcome.

  The data were recoded at 3 months after surgery.

Study Arms (2)

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.

Other: Patients had a history of antithrombotic therapy

Patients without antithrombotic therapy

Patients without antithrombotic drugs were identified as controls

Other: Patients had no history of antithrombotic therapy

Interventions

Patients had a history of antithrombotic therapy OTHER

Patients with antithrombotic drugs were identified and grouped and their medical records were reviewed.

Patients on antithrombotic therapy

Patients had no history of antithrombotic therapy OTHER

Patients had no history of antithrombotic therapy

Patients without antithrombotic therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Wei-min Li, PhD.

  West China Hospital

  STUDY CHAIR

Central Study Contacts

Liao Peng, M.D.

CONTACT

18380453539; 602744188@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: February 3, 2022
• Study Start: July 4, 2019
• Primary Completion: February 10, 2024
• Study Completion: April 10, 2024
• Last Updated: September 15, 2023

Record last verified: 2023-09

Locations

CN (1)