Effect of Vulvar Re-Antisepsis Before Cystoscopy on Urinary Infections in Laparoscopic Hysterectomy

This prospective observational study aims to evaluate whether additional vulvar re-antisepsis before intraoperative cystoscopy reduces the incidence of postoperative urinary tract infections (UTIs) in patients undergoing total laparoscopic hysterectomy for benign indications. In our institution, cystoscopy is routinely performed at the end of laparoscopic hysterectomy using carbon dioxide (CO₂) as the distension medium to assess bladder integrity and ureteral jet flow. However, potential contamination from the vaginal flora during cystoscopy may increase the risk of postoperative UTI. The study will compare two groups of patients: those receiving standard preoperative antisepsis only and those undergoing additional vulvar re-antisepsis immediately before cystoscopy. The primary outcome is the incidence of postoperative UTI diagnosed according to CDC criteria. Secondary outcomes include cystoscopy duration, catheterization time, and need for postoperative antibiotic therapy. Findings from this study may help determine whether an additional antisepsis step can improve infection control during laparoscopic hysterectomy.

Study Overview

• Status: Active, not recruiting
• Conditions: Cystoscopy; Laparoscopic Hysterectomy; Postoperative Urinary Tract Infection; Antisepsis
• Intervention / Treatment: Procedure: Additional Vulvar Re-Antisepsis Before Cystoscopy

Detailed Description

Urinary tract infection (UTI) is one of the most common postoperative complications following gynecologic surgery. In our institution, intraoperative cystoscopy is routinely performed during total laparoscopic hysterectomy (TLH) to assess bladder and ureteral integrity and to enable early detection of possible injuries. In our clinic, cystoscopy is performed using carbon dioxide (CO₂) as the distension medium. However, contamination of the cystoscope or instruments with vaginal flora during insertion may contribute to postoperative infections.

This prospective observational study aims to investigate whether performing additional vulvar re-antisepsis immediately before cystoscopy reduces postoperative UTI rates in patients undergoing TLH for benign indications.

Participants will be adult women undergoing TLH with intraoperative cystoscopy. The study population will be divided into two groups:

Group 1: Standard preoperative antisepsis only Group 2: Additional vulvar re-antisepsis performed immediately before cystoscopy

The primary outcome measure will be the incidence of postoperative UTI diagnosed in the early postoperative period according to CDC/NHSN criteria. Secondary outcomes will include cystoscopy duration, duration of urinary catheterization, and the need for postoperative antibiotic therapy.

All data will be collected prospectively using standardized case report forms. The findings of this study are expected to clarify whether a simple additional antisepsis step can effectively reduce postoperative UTIs without increasing operative time or procedural complexity, thereby contributing to infection control strategies during laparoscopic hysterectomy.

• Study Type: Observational
• Enrollment (Estimated): 98

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • İzmir
    • Bornova, İzmir, Turkey (Türkiye), 35100
      • University of Health Sciences Tepecik Training and Research Hospital, Department of Obstetrics and Gynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

dult women (≥18 years) undergoing total laparoscopic hysterectomy for benign gynecologic indications at the University of Health Sciences Tepecik Training and Research Hospital Department of Gynecology and Obsterics.

Description

Inclusion Criteria:

• Women aged 18 years and older
• Undergoing total laparoscopic hysterectomy (TLH) for benign gynecologic indications
• Intraoperative cystoscopy planned as part of the surgical procedure
• No evidence of urinary tract infection before surgery
• Willingness to participate and provide informed consent

Exclusion Criteria:

• Positive preoperative urine culture
• Known immunodeficiency or current use of immunosuppressive therapy
• Patients with diabetes mellitus whose blood glucose levels are poorly controlled
• History of bladder or ureteral anatomical anomalies
• Cases converted to another surgical route or completed via the vaginal route
• Patients whose final pathology reveals malignant disease

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard Antisepsis; Patients undergoing total laparoscopic hysterectomy who receive routine preoperative vulvar antisepsis only. Cystoscopy is performed at the end of the procedure using carbon dioxide (CO₂) as the distension medium, without any additional re-antisepsis before cystoscope insertion.
Re-Antisepsis Before Cystoscopy; Patients undergoing total laparoscopic hysterectomy who receive additional vulvar re-antisepsis immediately before intraoperative cystoscopy. The cystoscopy is performed using carbon dioxide (CO₂) as the distension medium to evaluate bladder integrity and ureteral jets.	Procedure: Additional Vulvar Re-Antisepsis Before Cystoscopy; In this observational cohort, some patients receive an additional vulvar re-antisepsis immediately before intraoperative cystoscopy during total laparoscopic hysterectomy. The antisepsis is performed using standard povidone-iodine solution prior to cystoscope insertion. Cystoscopy is conducted using carbon dioxide (CO₂) as the distension medium.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Postoperative Urinary Tract Infection (CDC/NHSN Criteria)	Proportion of participants who develop a postoperative urinary tract infection (UTI) within 6 weeks after total laparoscopic hysterectomy, defined according to CDC/NHSN criteria (symptoms and signs consistent with UTI plus laboratory confirmation on urine testing or culture). Asymptomatic bacteriuria will not be counted as UTI. Diagnosis will be based on clinical follow-up evaluations, electronic medical records, and microbiology reports.	Within 6 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Time Required for Cystoscopy Procedure Including Re-Antisepsis Step	During surgery	From the start of cystoscopy preparation to removal of the cystoscope (typically 2-5 minutes).

Collaborators and Investigators

• Sponsor: Alaattin Karabulut

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2025
• Primary Completion (Actual): March 10, 2026
• Study Completion (Estimated): April 15, 2026

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 15, 2025
• First Posted (Actual): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 12, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Urinary Tract Infection; cystoscopy; Infection Prevention; Laparoscopic Hysterectomy; vulvar antisepsis
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Urinary Tract Infections
• Other Study ID Numbers: TepecikTRH-AKarabulut-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified individual participant data will not be shared publicly. Summary-level data may be available upon reasonable request after publication of the study results.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No