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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07530484
Acronym
SUI-SLING
Enrollment
184
Registered
2026-04-15
Start date
2017-10-01
Completion date
2019-10-31
Last updated
2026-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Stress Urinary Incontinence, Stress Urinary Incontinence (SUI)

Keywords

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

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.

Detailed description

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.

Interventions

None listed

Sponsors

Shin Kong Wu Ho-Su Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Objective cure rate at 6 months6 months after surgeryObjective cure is defined as a negative cough stress test and no requirement for additional anti-incontinence treatment at 6 months after surgery.

Secondary

MeasureTime frameDescription
Objective cure rate at 1 and 3 months1 month and 3 monthsObjective cure defined as a negative cough stress test without need for additional treatment at 1 and 3 months postoperatively.
Postoperative voiding difficultyWithin 6 months after surgeryIncidence of postoperative voiding difficulty requiring catheterization or clinical intervention.
Persistent stress urinary incontinence symptomsUp to 6 monthsPresence of persistent subjective stress urinary incontinence symptoms reported by patients after surgery.
Quality of life measured by I-QOL score6 monthsQuality 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 16, 2026