Stress Urinary Incontinence (SUI)SUI-SLINGNCT07530484
Sling Insertion Angle and Outcomes in Single-Incision Midurethral Sling Surgery
An observational study of Stress Urinary Incontinence (SUI) and Female Stress Urinary Incontinence, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence (SUI), Female Stress Urinary Incontinence
- How many people
- 184 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2017to 31 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Sling Insertion Angle on Surgical Outcomes and Quality of Life Following Single-Incision Midurethral Sling Surgery for Stress Urinary Incontinence
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).
Read more
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.
Read the 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.
- Keywords
- Single-incision midurethral sling, Sling insertion angle, Stress urinary incontinence, I-QOL, Objective cure, Voiding dysfunction
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after surgery
Secondary outcomes (4)
Objective cure rate at 1 and 3 months
Objective cure defined as a negative cough stress test without need for additional treatment at 1 and 3 months postoperatively.
Measured: 1 month and 3 months
Postoperative voiding difficulty
Incidence of postoperative voiding difficulty requiring catheterization or clinical intervention.
Measured: Within 6 months after surgery
Persistent stress urinary incontinence symptoms
Presence of persistent subjective stress urinary incontinence symptoms reported by patients after surgery.
Measured: Up to 6 months
Quality of life measured by I-QOL score
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 Oct 2017
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary Incontinence (SUI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu, wan-ru, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530484
- Sponsor's protocol ID
- SKH-20260203R-SUI
- Acronym
- SUI-SLING
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to patient privacy concerns and institutional restrictions. The data contain potentially identifiable clinical information, and sharing is not permitted under the approval of the Institutional Review Board. De-identified data may be available from the corresponding author upon reasonable request and with appropriate institutional approvals.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sling Insertion Angle on Surgical Outcomes and Quality of Life Following Single-Incision Midurethral Sling Surgery for Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT07530484
- Acronym / sponsor ID
- SUI-SLING / SKH-20260203R-SUI
- Keywords
- Single-incision midurethral sling, Sling insertion angle, Stress urinary incontinence, I-QOL, Objective cure, Voiding dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Objective cure rate at 1 and 3 months
Time frame: 1 month and 3 months
Postoperative voiding difficulty
Time frame: Within 6 months after surgery
Persistent stress urinary incontinence symptoms
Time frame: Up to 6 months
Quality of life measured by I-QOL score
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to patient privacy concerns and institutional restrictions. The data contain potentially identifiable clinical information, and sharing is not permitted under the approval of the Institutional Review Board. De-identified data may be available from the corresponding author upon reasonable request and with appropriate institutional approvals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence (SUI) and Female Stress Urinary Incontinence, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective cure rate at 6 months (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026; AzTrials last refreshed its copy on 2 Nov 2026.