An interventional study of Routine Urinary Catheterization and No Routine Urinary Catheterization in Inguinal Hernias, sponsored by Ugur Duman. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Ugur Duman · Not applicable, Interventional, and Prevention
The goal of this randomized controlled clinical trial is to determine whether avoiding routine urinary catheterization reduces postoperative urinary symptoms in patients undergoing laparoscopic totally extraperitoneal (TEP) inguinal hernia repair.
The main questions it aims to answer are:
Participants will:
Routine urinary catheterization is commonly performed during laparoscopic totally extraperitoneal (TEP) inguinal hernia repair to maintain bladder decompression and facilitate preperitoneal dissection. However, catheter placement may cause postoperative urinary discomfort and urethral irritation. The clinical necessity of routine catheterization during TEP repair remains uncertain.
This prospective, single-center, randomized controlled trial was designed to evaluate the effects of routine urinary catheterization on postoperative urinary symptoms and surgical safety.
All procedures were performed under general anesthesia by a single surgeon with 24 years of surgical experience. A standardized laparoscopic TEP technique was used in both groups. The preperitoneal working space was established using balloon dissection, followed by identification and dissection of the hernia sac and exposure of the myopectineal orifice. A polypropylene mesh was placed to cover the myopectineal orifice, with limited fixation. Hemostasis was confirmed, and no surgical drains were routinely placed.
In the catheterization group, the urinary catheter was maintained throughout the immediate postoperative period and removed before discharge, approximately 24 hours after surgery. Patients in the no-catheterization group underwent the same surgical procedure without routine urinary catheter placement.
Postoperative urinary symptoms were evaluated through patient-reported assessments and clinical follow-up. Urinary or urethral pain intensity was measured using a 0-10 visual analog scale (VAS), with higher scores indicating greater pain intensity.
The study was designed to assess whether omission of routine urinary catheterization could improve postoperative patient comfort while maintaining the safety of laparoscopic TEP inguinal hernia repair.
561 studies on the registry are indexed under Hernia, Inguinal; 76 are open to participants now.
This study's enrollment of 100 is above the median of 90 across 414 interventional studies indexed under Hernia, Inguinal.
Browse Hernia, Inguinal studies →Ugur Duman is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants assigned to this group underwent laparoscopic total extraperitoneal (TEP) inguinal hernia repair without routine perioperative urinary catheterization. The surgical procedure was performed under general anesthesia using a standardized technique. Postoperative urinary symptoms, urinary retention, and surgical complications were assessed during follow-up.
Procedure: No Routine Urinary Catheterization
Participants assigned to this group underwent laparoscopic totally extraperitoneal (TEP) inguinal hernia repair with routine perioperative urinary catheterization. A urinary catheter was placed during the perioperative period and removed before hospital discharge, approximately 24 hours after surgery. Postoperative urinary symptoms, urinary retention, and surgical complications were assessed during follow-up.
Procedure: Routine Urinary Catheterization
Routine perioperative urinary catheterization was performed in participants undergoing laparoscopic total extraperitoneal inguinal hernia repair. The urinary catheter was maintained during the immediate postoperative period and removed before hospital discharge, approximately 24 hours after surgery.
Participants underwent laparoscopic total extraperitoneal inguinal hernia repair without routine perioperative urinary catheter placement. Postoperative urinary symptoms and urinary retention were assessed using the same follow-up schedule as the catheterization group.
Incidence of Dysuria on Postoperative Day 1
The primary outcome was the incidence of postoperative dysuria, defined as patient-reported pain, burning, or discomfort during urination within the first 24 hours following laparoscopic total extraperitoneal inguinal hernia repair. Dysuria was assessed as a binary outcome (present or absent). The proportion of participants experiencing dysuria was compared between the urinary catheterization and no-catheterization groups.
Time frame: Postoperative Day 1 (within 24 hours after surgery)
Incidence of Urinary or Urethral Pain on Postoperative Day 1
The presence of urinary or urethral pain was assessed on postoperative day 1 using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain). Pain was considered present when the VAS score was greater than 0. The proportion of participants reporting pain was compared between the two study groups.
Time frame: Postoperative Day 1 (within 24 hours after surgery)
Incidence of Urinary or Urethral Pain on Postoperative Day 10
Urinary or urethral pain was assessed on postoperative day 10 using a 0-10 visual analog scale (VAS). Pain was classified as present when the VAS score was greater than 0. The incidence of pain was compared between the urinary catheterization and no-catheterization groups.
Time frame: Postoperative Day 10
Incidence of Urinary or Urethral Pain on Postoperative Day 30
Urinary or urethral pain was assessed on postoperative day 30 using a visual analog scale (VAS) ranging from 0 to 10. Pain was defined as a VAS score greater than 0. The proportion of participants reporting pain was evaluated in each intervention group.
Time frame: Postoperative Day 30
Urinary or Urethral Pain Severity on Postoperative Day 1
The severity of urinary or urethral pain was assessed using an 11-point visual analog scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Pain scores were compared between the urinary catheterization and no-catheterization groups.
Time frame: Postoperative Day 1
Urinary or Urethral Pain Severity on Postoperative Day 10
Urinary or urethral pain intensity was measured using a 0-10 visual analog scale (VAS) on postoperative day 10. Higher scores indicated greater pain intensity.
Time frame: Postoperative Day 10
Urinary or Urethral Pain Severity on Postoperative Day 30
Urinary or urethral pain intensity was evaluated on postoperative day 30 using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).
Time frame: Postoperative Day 30
Incidence of Urinary or Urethral Pain During the First 30 Postoperative Days
The composite incidence of postoperative urinary or urethral pain was defined as the presence of pain (VAS score greater than 0) at any of the scheduled postoperative assessments on days 1, 10, or 30. Participants reporting pain at least once during the follow-up period were classified as having experienced urinary or urethral pain. The proportion of affected participants was compared between the two groups.
Time frame: Postoperative Days 1, 10, and 30
Incidence of Postoperative Urinary Retention
Postoperative urinary retention was assessed during postoperative follow-up. The incidence of urinary retention was recorded as a binary outcome (present or absent), and the proportion of affected participants was compared between the urinary catheterization and no-catheterization groups.
Time frame: Within 30 days after surgery
Incidence of Postoperative Complications
Postoperative complications were assessed during the first 30 days after laparoscopic TEP inguinal hernia repair. Recorded complications included urinary retention, scrotal emphysema, and scrotal ecchymosis. The proportion of participants experiencing at least one postoperative complication was compared between the intervention groups.
Time frame: Within 30 days after surgery
Incidence of Inguinal Hernia Recurrence Within Six Months
Hernia recurrence was assessed during a six-month postoperative follow-up period. Recurrence was defined as the reappearance of an inguinal hernia following laparoscopic TEP repair, as identified through postoperative clinical evaluation. The proportion of participants experiencing recurrence was compared between the two intervention groups.
Time frame: Up to 6 months after surgery
Plan to share: No — Individual participant data will not be made publicly available due to patient confidentiality considerations and the absence of a predefined individual participant data-sharing plan in the study protocol.
No publications or documents are linked to this record.
Ran from Mar 2026 to primary completion in Jun 2026, 3 months.
Of 181 non-industry interventional studies with no phase under Hernia, Inguinal, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 35. This study's 3 months is below that.
Counting every sponsor, half of 190 studies reached it within 17 months; a quarter within 8 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ugur Duman