Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan, 111
NCT Number: NCT07530484
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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Notify Me18 year and older
Female
Observational
Taipei, Taiwan, 111
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Within 6 months after surgery
Incidence of postoperative voiding difficulty requiring catheterization or clinical intervention.
Time frame: Up to 6 months
Presence of persistent subjective stress urinary incontinence symptoms reported by patients after surgery.
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.
Shin Kong Wu Ho-Su Memorial Hospital
Other
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
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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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