Retropubic vs. Single-Incision Mid-Urethral Sling for Stress Urinary Incontinence

Not Applicable

Completed

• Conditions: Stress Urinary Incontinence; Pelvic Floor Disorders

• Registration Number: NCT03520114
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-4-26
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 280

Inclusion Criteria

Inclusion Criteria:<br><br> - At least 21 years of age<br><br> - Women being considered for a native tissue vaginal repair in any vaginal compartment<br> or colpocleisis<br><br> - POP = stage II of any vaginal compartment, according to the pelvic organ prolapse<br> quantification (POP-Q) system<br><br> - Vaginal bulge symptoms<br><br> - Positive standardized cough stress test on clinical examination, or on urodynamic<br> testing<br><br> - Surgical plan that includes a native tissue vaginal repair including colpocleisis<br> for symptomatic POP in any compartment<br><br> - Understanding and acceptance of the need to return for all scheduled follow-up<br> visits<br><br> - English speaking and able to give informed consent<br><br> - Willing and able to complete all study questionnaires<br><br>Exclusion Criteria:<br><br> - Prior surgery for stress urinary incontinence<br><br> - Status post reconstructive pelvic surgery with transvaginal mesh kits or<br> sacrocolpopexy with synthetic mesh for prolapse<br><br> - Any serious disease, or chronic condition, that could interfere with the study<br> compliance<br><br> - Unwilling to have a synthetic sling<br><br> - Inability to give informed consent<br><br> - Pregnancy or planning pregnancy in the first postoperative year<br><br> - Untreated urinary tract infection (may be included after resolution)<br><br> - Poorly-controlled diabetes mellitus (HgbA1c > 9 within 3 months of surgery date)<br><br> - Prior pelvic radiation<br><br> - Incarcerated<br><br> - Neurogenic bladder/ pre-operative self-catheterization<br><br> - Elevated post-void residual (>150 ml) that does not resolve with prolapse reduction<br> testing (pessary, prolapse reduced uroflow or micturition study)<br><br> - Prior augmented (synthetic mesh, autologous graft, xenograft, allograft) prolapse<br> repair<br><br> - Planned concomitant bowel related surgery including sphincteroplasty and perineal<br> rectal prolapse surgery, rectovaginal fistula repair, hemorrhoidectomy.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with subjectively bothersome stress incontinence;Retreatment for stress incontinence;De novo or worsening urge incontinence symptoms;Requirement for bladder drainage;Surgical intervention for urinary retention

Secondary Outcome Measures

Name	Time	Method
Adverse events;Change in pain;Surgeon satisfaction