Sling Insertion Angle and Outcomes in Single-Incision Midurethral Sling Surgery

NCT07530484 | Completed

• 1 other identifier: SKH-20260203R-SUI
• Study Type: observational
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of sling insertion angle on surgical outcomes and quality of life in women with stress urinary incontinence (SUI) undergoing single-incision midurethral sling surgery. Women diagnosed with urodynamic stress urinary incontinence who underwent surgery using a single-incision sling system were included. Patients were categorized into two groups based on sling insertion angle: an acute-angle group (\<45°, resembling a retropubic trajectory) and a standard-angle group (approximately 45°, toward the obturator foramen). The primary outcome was objective cure at 6 months, defined as a negative cough stress test without the need for additional anti-incontinence treatment. Secondary outcomes included objective cure at 1 and 3 months, postoperative voiding difficulty, persistent SUI symptoms, and quality of life assessed using the Incontinence Quality of Life (I-QOL) questionnaire. This study provides clinical evidence on whether sling insertion angle influences early and mid-term outcomes following single-incision midurethral sling surgery.

Conditions

Stress Urinary Incontinence (SUI); Female Stress Urinary Incontinence

Keywords

Single-incision midurethral sling; Sling insertion angle; Stress urinary incontinence; I-QOL; Objective cure; Voiding dysfunction

Outcome Measures

Primary Outcomes (1)

• Objective cure rate at 6 months

  Objective cure is defined as a negative cough stress test and no requirement for additional anti-incontinence treatment at 6 months after surgery.

  6 months after surgery

Secondary Outcomes (4)

• Objective cure rate at 1 and 3 months

  1 month and 3 months

• Postoperative voiding difficulty

  Within 6 months after surgery

• Persistent stress urinary incontinence symptoms

  Up to 6 months

• Quality of life measured by I-QOL score

  6 months

Study Arms (2)

Acute-angle sling group (<45°)

Participants undergoing single-incision midurethral sling surgery with a sling insertion angle of less than 45 degrees, corresponding to a retropubic, TVT-like trajectory. This approach is hypothesized to provide earlier urethral support and improved early continence outcomes.

Standard-angle sling group (≈45°)

Participants undergoing single-incision midurethral sling surgery with a standard sling insertion angle of approximately 45 degrees toward the obturator foramen. This represents the conventional transobturator-oriented trajectory used in routine clinical practice.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult female patients diagnosed with urodynamic stress urinary incontinence who underwent single-incision midurethral sling surgery at a tertiary medical center. All procedures were performed by a single experienced surgeon, and patients had available follow-up data for at least 6 months.

You may qualify if:

• Female patients aged 18 years or older
• Diagnosis of urodynamic stress urinary incontinence (SUI)
• Preoperative 1-hour pad test \>10 g
• Undergoing single-incision midurethral sling surgery (ContaSure Needleless system)
• Availability of complete clinical and follow-up data for at least 6 months

You may not qualify if:

• Presence of detrusor overactivity on urodynamic study
• Mixed urinary incontinence with predominant urge symptoms
• Voiding dysfunction
• History of prior pelvic or anti-incontinence surgery
• Neurological disorders affecting lower urinary tract function
• Pelvic organ prolapse stage ≥ III (POP-Q classification)

Sponsors & Collaborators

• Shin Kong Wu Ho-Su Memorial Hospital: lead

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan, 111, Taiwan

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Department of Obstetrics and Gynecology, Shin Kong Wu Ho-Su Memorial Hospital

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 15, 2026
• Study Start: October 1, 2017
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)