Retropubic vs. Single-Incision Mid-Urethral Sling for Stress Urinary Incontinence
| Status: | Recruiting |
|---|---|
| Conditions: | Urology, Urology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 12/22/2018 |
| Start Date: | December 12, 2018 |
| End Date: | June 2020 |
| Contact: | Janet Shuping |
| Email: | jshuping@wakehealth.edu |
| Phone: | 336-716-2612 |
Randomized Trial of Retropubic Versus Single-incision Mid-Urethral Sling (Altis ) for Concomitant Management of Stress Urinary Incontinence During Native Tissue Vaginal Repair
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 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.
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 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.
Pelvic floor surgeons aspire to improve relevant quality of life outcomes for women with
pelvic floor disorders while minimizing complications and unnecessary procedures. Efficacy
and risk always compete for equilibrium. Level I evidence has demonstrated a positive
efficacy benefit of a concomitant synthetic mid-urethral sling in women with, and without,
pre-operative symptoms of SUI who are undergoing POP repair. Concomitant sling placement has
been shown to reduce the risk of de novo or persistent SUI from 50% to 23%. The combination
of surgical treatment of POP and SUI at the same time, however, increases the risk of
incomplete bladder emptying. 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. As the combination of POP and sling surgery increases
the risk of voiding dysfunction, and rates of incomplete bladder emptying appear
significantly lower for SIS than RP slings, the study team hypothesizes that the use of the
Altis ™ SIS will be non-inferior to RP slings in efficacy and superior in irritative voiding
symptoms/voiding dysfunction at one year after combined surgery.
pelvic floor disorders while minimizing complications and unnecessary procedures. Efficacy
and risk always compete for equilibrium. Level I evidence has demonstrated a positive
efficacy benefit of a concomitant synthetic mid-urethral sling in women with, and without,
pre-operative symptoms of SUI who are undergoing POP repair. Concomitant sling placement has
been shown to reduce the risk of de novo or persistent SUI from 50% to 23%. The combination
of surgical treatment of POP and SUI at the same time, however, increases the risk of
incomplete bladder emptying. 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. As the combination of POP and sling surgery increases
the risk of voiding dysfunction, and rates of incomplete bladder emptying appear
significantly lower for SIS than RP slings, the study team hypothesizes that the use of the
Altis ™ SIS will be non-inferior to RP slings in efficacy and superior in irritative voiding
symptoms/voiding dysfunction at one year after combined surgery.
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.
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