N/A
N=255
Retropubic vs. Single-Incision Mid-Urethral Sling for Stress Urinary Incontinence
Stress Urinary Incontinence · Pelvic Floor Disorders
Bottom Line
View on ClinicalTrials.gov: NCT03520114 ↗Enrolled (actual)
255
Serious AEs
5.1%
Results posted
Jan 2025
Primary outcome: Primary: Number of Participants With Subjectively Bothersome Stress Incontinence — 129; 126 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RP sling placement (Device); SIS placement (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Subjectively Bothersome Stress Incontinence |
129; 126 | — |
| PRIMARY Count of Participants Needing Retreatment for Stress Incontinence |
3; 5 | — |
| PRIMARY Count of Participants With De Novo or Worsening Urge Incontinence Symptoms |
3; 3 | — |
| PRIMARY Count of Participants Requiring Bladder Drainage |
0; 0 | — |
| PRIMARY Count of Participants Needing Surgical Intervention for Urinary Retention |
3; 4 | — |
| SECONDARY Number of Participants With Adverse Events |
47; 53 | — |
| SECONDARY Surgeon Satisfaction Scores |
9; 8 | — |
Summary
One in five women will undergo prolapse surgery in their lifetime, and there is a strong correlation between prolapse and urinary incontinence. Pelvic floor surgeons aspire to improve relevant quality of life outcomes for women with pelvic floor disorders while minimizing complications and unnecessary procedures. There has been an experience of disappointment and frustration when a patient returns following POP repair with new symptoms of Stress Urinary Incontinence (SUI) that she ranks as a greater disruption to her quality of life than her original vaginal bulge. While retropubic (RP) slings are considered to be the "gold-standard" referent for other slings with long-term outcomes data, they are associated with the highest risks of intra- and post-operative complications including bladder injury, bleeding, and post-operative voiding dysfunction. Single-incision slings (SIS) are the latest iteration in sling development that build upon the benefits of slings but avoid passage through the muscles of the inner thigh. The hypothesis for this study is that single-incision slings (Altis) are non-inferior to Retropubic mid-urethral slings when placed at the time of native tissue vaginal repair.
Eligibility Criteria
Inclusion Criteria
- At least 21 years of age
- Women being considered for a native tissue vaginal repair in any vaginal compartment or colpocleisis
- POP ≥ stage II of any vaginal compartment, according to the pelvic organ prolapse quantification (POP-Q) system
- Vaginal bulge symptoms
- Positive standardized cough stress test on clinical examination, or on urodynamic testing
- Surgical plan that includes a native tissue vaginal repair including colpocleisis for symptomatic POP in any compartment
- Understanding and acceptance of the need to return for all scheduled follow-up visits
- English speaking and able to give informed consent
- Willing and able to complete all study questionnaires
Exclusion Criteria
- Prior surgery for stress urinary incontinence
- Status post reconstructive pelvic surgery with transvaginal mesh kits or sacrocolpopexy with synthetic mesh for prolapse
- Any serious disease, or chronic condition, that could interfere with the study compliance
- Unwilling to have a synthetic sling
- Inability to give informed consent
- Pregnancy or planning pregnancy in the first postoperative year
- Untreated urinary tract infection (may be included after resolution)
- Poorly-controlled diabetes mellitus (HgbA1c > 9 within 3 months of surgery date)
- Prior pelvic radiation
- Incarcerated
- Neurogenic bladder/ pre-operative self-catheterization
- Elevated post-void residual (>150 ml) that does not resolve with prolapse reduction testing (pessary, prolapse reduced uroflow or micturition study)
- Prior augmented (synthetic mesh, autologous graft, xenograft, allograft) prolapse repair
- Planned concomitant bowel related surgery including sphincteroplasty and perineal rectal prolapse surgery, rectovaginal fistula repair, hemorrhoidectomy.
Data sourced from ClinicalTrials.gov (NCT03520114). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.