Evaluating the safety of bladder hydrodistension in patients on blood-thinning medications

Perioperative Safety of Bladder Hydrodistension in Patients on Antithrombotic Therapy

This study looks at how safe bladder hydrodistension is for patients with bladder pain who are taking blood-thinning medications.

Quick facts

• Study type: Observational
• Enrollment: 387 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: West China Hospital (Academic / other)
• Drugs / interventions: radiation, cyclophosphamide
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT05221944 on ClinicalTrials.gov

What this trial studies

This observational study reviews patients with interstitial cystitis/bladder pain syndrome who underwent hydrodistension at West China Hospital from January 2010 to May 2021. It aims to assess the perioperative safety and complications associated with hydrodistension in patients receiving antithrombotic therapy. The study involves a retrospective analysis of medical records, including patient demographics, symptom assessments, and perioperative parameters. Follow-up evaluations are conducted via telemedicine to monitor complications and symptoms post-surgery.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with a diagnosis of interstitial cystitis/bladder pain syndrome for more than six months who are undergoing hydrodistension.

Not a fit: Patients currently diagnosed with cancer, severe systemic disorders, or recent urinary infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the safety of bladder hydrodistension for patients on antithrombotic therapy, potentially improving surgical outcomes.

How similar studies have performed: While this study focuses on a specific patient population, similar studies have explored the safety of procedures in patients on antithrombotic therapy, indicating a growing interest in this area.

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.

Where this trial is running

Chengdu, Sichuan

• West China Hospital — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Liao Peng, M.D.

Conditions Complication; Interstitial cystitis; Antithrombotic therapy; Bladder hydrodistension