Perioperative Safety of Bladder Hydrodistension in Patients on Antithrombotic Therapy

Launched by WEST CHINA HOSPITAL · Jan 21, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the safety of a procedure called bladder hydrodistension in patients who are taking blood-thinning medications, known as antithrombotic therapy. The study focuses on patients diagnosed with interstitial cystitis/bladder pain syndrome (IC/BPS), a condition that causes chronic bladder pain and discomfort. Researchers are looking to see if this procedure leads to more complications for these patients compared to those not on antithrombotic therapy.

To participate, individuals must be over 18 years old, have been diagnosed with IC/BPS for more than six months, and have specific symptoms that indicate the severity of their condition. Participants will have their medical history reviewed, and those who meet the criteria will undergo the hydrodistension procedure. After the procedure, they will be contacted for a follow-up using telemedicine to check on any complications and how they are feeling. This trial aims to provide important insights on the safety of performing bladder hydrodistension in patients on blood thinners, helping doctors make better decisions for their patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Over 18 years old when signing an informed consent;
• • 2. Previously diagnosed with IC/BPS for a duration of \> 6 months;
• • 3. O'Leary-Sant Interstitial Cystitis Symptom and Problem Index scores over 18;
• • 4. Undergoing hydrodistension during the hospitalization;
• • 5. Patients with adequate medical records.
• Exclusion Criteria:
• • 1. 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.
• • 2. 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.
• • 1. Bladder diseases (carcinoma, overactive bladder, neurogenic bladder, bladder stone, radiation cystitis)
• • 2. Urethral diseases (urethral diverticulum, urethral stricture, urethral stone)
• • 3. Gynaecological diseases (endometriosis, uterine fibroids, vaginitis, menopausal syndrome, pelvic organ prolapse)
• • 4. 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.
• • 3. 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.