Clinical trial NCT03520114: Retropubic vs. Single-Incision Mid-Urethral Sling for Stress Urinary Incontinence
Official title: Randomized Trial of Retropubic Versus Single-incision Mid-Urethral Sling (Altis ) for Concomitant Management of Stress Urinary Incontinence During Native Tissue Vaginal Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Pelvic Floor Disorders
Keywords: Retropubic sling
Single-incision sling
Vaginal repair
Management
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Foundation for Female Health Awareness
First posted: 2018-05-09
Enrollment: 280
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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 Single-incision Mid-Urethral Sling SIS will be non-inferior to RP slings in efficacy and superior in irritative voiding symptoms/voiding dysfunction at one year after combined surgery.

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.

Primary outcomes:
measure: Number of Participants With Subjectively Bothersome Stress Incontinence
timeFrame: 12 months post-operatively
measure: Count of Participants Needing Retreatment for Stress Incontinence
timeFrame: 12 months post-operatively
measure: Count of Participants With De Novo or Worsening Urge Incontinence Symptoms
timeFrame: 12 months post-operatively
measure: Count of Participants Requiring Bladder Drainage
timeFrame: 12 Month post-operatively
measure: Count of Participants Needing Surgical Intervention for Urinary Retention
timeFrame: 12 Month post-operatively
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 12 months post-operatively
measure: Surgeon Satisfaction Scores
timeFrame: post-operatively up to 12 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Health/National Center for Advance Pelvic Surgery
state: District of Columbia
city: Chicago
country: United States
facility: Northwestern Medical Group
state: Illinois
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Providence
country: United States
facility: Women & Infants Hospital of Rhode Island
state: Rhode Island
Study officials:
affiliation: Wake Forest University Health Sciences
name: Catherine Matthews, MD
role: PRINCIPAL_INVESTIGATOR
References: