Effect of Intraurethral Guardix-SOL Application on Postoperative Voiding Function After Transurethral Resection of Bladder Tumor: a Prospective Randomized Controlled Study

Authors
Category Primary study
Registry of TrialsKorean Clinical Trials Database
Year 2026
INTERVENTION: Medical Device : A single‐center, prospective, randomized, assessor‐blinded, parallel‐group comparative study with 1:1 block randomization (using variable block sizes). Subjects will be randomized sequentially upon enrollment via sealed opaque envelopes or an electronic randomization system. Follow‐up time points are Baseline (preoperation), Postoperative Day (POD) 8–10, and 3 months postoperatively. Test group: After completion of Transurethral Resection of Bladder Tumor (TUR‐BT) and confirmation of bleeding control, Guardix‐SOL 5g is applied to the urethral mucosa. Control group: After Transurethral Resection of Bladder Tumor (TUR‐BT), only the institution's standard postoperative care is performed. All surgeries are performed according to the standard method of Transurethral Resection of Bladder Tumor (TUR‐BT). After tumor resection and hemostasis are complete, Guardix‐SOL 5g is applied to the urethral mucosa in the test group. Guardix‐SOL is injected into the urethra through the working channel of a cystoscope or resectoscope and is applied to ensure even coating on the urethral mucosa as the endoscope is slowly withdrawn. The objective is to form a temporary protective barrier on the urethral mucosa surface to alleviate inflammatory responses and fibrosis that may occur after mucosal injury caused by instrument insertion. In both the test and control groups, a Foley catheter is inserted after surgery according to the institution's standard postoperative care, and subsequent postoperative care and follow‐up proceed according to the identical protocol. CONDITION: Neoplasms PRIMARY OUTCOME: Confirmation of changes in the International Prostate Symptom Score (IPSS) voiding subscore SECONDARY OUTCOME: Confirmation of postoperative pain duration of gross hematuria INCLUSION CRITERIA: • Patients scheduled to undergo transurethral resection of bladder tumor (TUR‐BT) • Adult patients aged 19 years or older • Patients who have received a sufficient explanation regarding the purpose and procedures of the study and have provided written informed consent
Epistemonikos ID: cc06943659de73521a3b4675b6b21ef335e79b07
First added on: Aug 10, 2026