Status:

UNKNOWN

Perioperative Safety of Bladder Hydrodistension in Patients on Antithrombotic Therapy

Lead Sponsor:

West China Hospital

Conditions:

Complication

Eligibility:

All Genders

18+ years

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 hospita...

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 ...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.

Key Trial Info

Start Date :

July 4 2019

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

April 10 2024

Estimated Enrollment :

387 Patients enrolled

Trial Details

Trial ID

NCT05221944

Start Date

July 4 2019

End Date

April 10 2024

Last Update

September 15 2023

Active Locations (1)

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West China Hospital

Chengdu, Sichuan, China, 610041