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Completed

NCT Number: NCT07530484

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

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.

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Key information

About this study

This prospective cohort study was conducted at a tertiary medical center and included women with urodynamic stress urinary incontinence (SUI) who underwent single-incision midurethral sling surgery between October 2017 and October 2019. All procedures were performed by a single experienced surgeon using a standardized surgical technique with the same sling system.

Patients were classified into two groups according to sling insertion angle: the acute-angle group (<45°), representing a trajectory similar to the retropubic approach, and the standard-angle group (approximately 45°), directed toward the obturator foramen. The sling angle was assessed intraoperatively based on the orientation of the insertion instrument.

Inclusion criteria

included women with confirmed urodynamic stress incontinence and a preoperative 1-hour pad test result greater than 10 grams. Exclusion criteria included detrusor overactivity, mixed urinary incontinence, prior pelvic surgery, voiding dysfunction, neurological disease, and pelvic organ prolapse stage III or higher.

The primary outcome was objective cure at 6 months postoperatively, defined as a negative cough stress test and no requirement for additional anti-incontinence treatment. Secondary outcomes included objective cure rates at 1 and 3 months, postoperative voiding difficulty, persistent SUI symptoms, and quality of life assessed using the validated Incontinence Quality of Life (I-QOL) questionnaire.

Postoperative follow-up evaluations were conducted at 1, 3, and 6 months. Clinical outcomes and complications were systematically recorded and analyzed to determine whether sling insertion angle affects surgical efficacy and patient-reported outcomes.

The study was approved by the Institutional Review Board of Shin Kong Wu Ho-Su Memorial Hospital, and all procedures were conducted in accordance with the Declaration of Helsinki.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

  1. Objective cure rate at 6 months

    Time frame: 6 months after surgery

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

Secondary outcomes

  1. Objective cure rate at 1 and 3 months

    Time frame: 1 month and 3 months

    Objective cure defined as a negative cough stress test without need for additional treatment at 1 and 3 months postoperatively.

  2. Postoperative voiding difficulty

    Time frame: Within 6 months after surgery

    Incidence of postoperative voiding difficulty requiring catheterization or clinical intervention.

  3. Persistent stress urinary incontinence symptoms

    Time frame: Up to 6 months

    Presence of persistent subjective stress urinary incontinence symptoms reported by patients after surgery.

  4. Quality of life measured by I-QOL score

    Time frame: 6 months

    Quality of life assessed using the Incontinence Quality of Life (I-QOL) questionnaire, with scores ranging from 0 to 100, where higher scores indicate better quality of life.

Sponsors and collaborators

Lead sponsor

Shin Kong Wu Ho-Su Memorial Hospital

Other

Registry information

Official study title

Effect of Sling Insertion Angle on Surgical Outcomes and Quality of Life Following Single-Incision Midurethral Sling Surgery for Stress Urinary Incontinence

Acronym: SUI-SLING

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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