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Prospective randomized comparison of the transobturator mid-urethral sling with the single-incision sling (needleless) among women with stress urinary incontinence: 1-year follow-up study

Prospective randomized comparison of the transobturator mid-urethral sling with the single-incision sling (needleless) among women with stress urinary incontinence: 1-year follow-up study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-16008068
Enrollment
Unknown
Registered
2016-03-08
Start date
2016-04-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

women with stress urinary incontinence

Interventions

Group TOT:the inside-out transobturator sling (TOT)
Group needleless:the innovative single-incision sling (needleless)

Sponsors

South Campus, Renji Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
30 Years to 75 Years

Inclusion criteria

Inclusion criteria: women with pure urodynamic SUI confirmed during cystometry by a positive standardized cough stress test (CST) with urinary bladder filling of 250 ml in the lithotomy position.

Exclusion criteria

Exclusion criteria: Patients with urgency or predominant urgency incontinence, intrinsic sphincter deficiency (MUCP2), previous SUI surgery or pelvic organ prolapse (POP) surgery and the presence of other pathological conditions of the pelvic organs.

Design outcomes

Primary

MeasureTime frame
ICIQ-SF;Patient Global Impression of Improvement (PGI-I);patient's subjective satisfaction;one hour pad test;pelvic floor muscle testing;residual urine;numerical pain rating scale;Overactive Bladder Symptom Score;urine flow rate;abdominal leak-point pressure (ALPP);maximal urethral closure pressure(MUCP);the functional urethral length;

Secondary

MeasureTime frame
time of operation;time of retention catheterization;duration of hospital stay;hospitalization costs;blood loss postoperation;length and amount of operative incision;

Countries

China

Contacts

Public ContactLv Jianwei

South Campus, Renji Hospital, Shanghai Jiao Tong University School of Medicine

ljwass@126.com+86 18616934736

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026