Sling Insertion Angle and Outcomes in Single-Incision Midurethral Sling Surgery (NCT07530484) | Clinical Trial Compass
CompletedNot Applicable
Sling Insertion Angle and Outcomes in Single-Incision Midurethral Sling Surgery
Taiwan184 participantsStarted 2017-10-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.