Bladder training to improve urinary function after rectal cancer surgery

Effect of Intermittent Urethral Catheter Clamping Combined With Active Urination Training (ICCAUT) Strategy on Postoperative Urinary Dysfunction After Radical Rectal Cancer Surgery: a Single-Center Randomized Controlled Trial (ICCAUT-1)

This study tests if a new bladder training method can help people who have had rectal cancer surgery avoid urinary problems after their catheter is removed.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sex: All
• Sponsor: The First Hospital of Jilin University (Academic / other)
• Locations: 2 sites (Changchun, Jilin and 1 other locations)
• Trial ID: NCT06241703 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of a bladder training strategy called ICCAUT, which combines intermittent urethral catheter clamping with active urination training, in patients undergoing surgery for rectal cancer. Participants will be randomly assigned to either the ICCAUT group, which receives bladder training, or a free-drainage group, which does not receive any specific training. The primary goal is to assess the incidence of urinary dysfunction following catheter removal, with secondary outcomes including urinary tract infections and time to first urination. The study aims to clarify the role of bladder training in improving postoperative urinary outcomes.

Who should consider this trial

Good fit: Ideal candidates are patients with a confirmed diagnosis of rectal cancer undergoing laparoscopic or robotic-assisted total mesorectal excision.

Not a fit: Patients with a history of significant abdominal surgery involving the rectum or those with pre-existing urinary dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce urinary dysfunction and improve recovery for patients after rectal cancer surgery.

How similar studies have performed: While bladder training strategies have been explored in other contexts, this specific approach is novel and has not been extensively tested in the setting of rectal cancer surgery.

Eligibility criteria

Inclusion Criteria:

1. Patients with a confirmed preoperative diagnosis of rectal cancer.
2. Patients with tumors located below the rectosigmoid junction (12 cm from the anal verge), as determined by preoperative computed tomography (CT) or rectal magnetic resonance imaging (MRI).
3. Patients undergoing laparoscopic or robotic-assisted total mesorectal excision (TME) for rectal cancer.

Exclusion Criteria:

1. History of abdominal surgery involving the rectum, sigmoid colon, left hemicolectomy, bladder resection or partial resection, prostate surgery, or hysterectomy.
2. History of urethral injury, cranial surgery, spinal surgery, stroke with limb dysfunction, or Parkinson's disease.
3. Inability to urinate through the urethra preoperatively due to various reasons (e.g., ureteral puncture or ureterostomy).
4. Presence of urinary tract infection preoperatively.
5. Previously diagnosed with bladder overactivity syndrome, urinary retention or voiding dysfunction, or diabetic bladder disease.
6. Concomitant resection of other pelvic organs was performed during surgery, including the bladder, prostate, uterus, cervix, and vagina, except for simple adnexal resection.
7. Lateral lymph node dissection for rectal cancer.
8. Injury to the ureter, bladder, or urethra during the perioperative period.
9. Preoperative renal dysfunction (serum creatinine level \>133 μmol/L).
10. Emergency surgery.
11. Male patients with preoperative benign prostatic hyperplasia receiving medication treatment.
12. Patients with a ureteral stent or ureteral stricture, or bilateral hydronephrosis.
13. Conversion to open surgery.

Where this trial is running

Changchun, Jilin and 1 other locations

• Firs Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
• First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)

Study contacts

• Principal investigator: Yuchen Guo, Ph.D. — The First Hospital of Jilin University
• Study coordinator: Yuchen Guo, Ph.D.

Conditions Urinary Dysfunction; Rectal Cancer; Urinary Catheterization; Urinary Retention Postoperative; Residual Urine Volume; Urinary Retention