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

• ClinicalTrials.gov Identifier: NCT03520114
• Recruitment Status: Recruiting
• First Posted: May 9, 2018
• Last Update Posted: December 23, 2020
• Sponsor: Wake Forest University Health Sciences
• Collaborator: Foundation for Female Health Awareness
• Information provided by (Responsible Party): Wake Forest University Health Sciences

Tracking Information

• First Submitted Date: April 26, 2018
• First Posted Date: May 9, 2018
• Last Update Posted Date: December 23, 2020
• Actual Study Start Date: December 12, 2018
• Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 26, 2018)

• Number of participants with subjectively bothersome stress incontinence [ Time Frame: 12 months post-operatively ]
  Dichotomous outcome (Yes/No), measured by a positive response of > 1 to Question 17 on Pelvic Floor Distress Inventory short form-20 (PFDI-20). Response scale from 0 to 4. Symptoms Not Present = NO 0 = not present Symptoms Present = YES, scale of bother: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = quite a bit
• Retreatment for stress incontinence [ Time Frame: 12 months post-operatively ]
  This includes pelvic floor physical therapy; incontinence pessary; urethral bulking injection; repeat incontinence surgery.
• De novo or worsening urge incontinence symptoms [ Time Frame: 12 months post-operatively ]
  Dichotomous outcome (Yes/No), measured by a worsening change in response to Question 16 on PFDI-20 with at least somewhat bothersome symptoms. Response scale from 0 to 4. Symptoms Not Present = NO 0 = not present Symptoms Present = YES, scale of bother: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = quite a bit
• Requirement for bladder drainage [ Time Frame: 12 Month post-operatively ]
  Beyond 2 weeks post-operatively with PVR > 150 ml OR > 1/3 total voided volume up to 12 Month post-operatively..
• Surgical intervention for urinary retention [ Time Frame: 12 Month post-operatively ]
  Sling lysis or revision at any time point post-operatively up to 12 Month post-operatively.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 17, 2018)

• Adverse events [ Time Frame: 12 months post-operatively ]
  Reporting of adverse events intra- and post-operatively and include adverse events as measured by the Dindo classification system.
• Change in pain [ Time Frame: up to 12 months post-operatively ]
  Pain will be measured on a visual analogue scale for 14 days post-operatively and at 6 weeks and 12 months post-operatively. The scale has a score range of 0-10, with 0=no pain and 10=worst pain .
• Surgeon satisfaction [ Time Frame: post-operatively up to 12 months ]
  Surgeon satisfaction with the sling will be assessed with a 10-point Likert Scale. The scale has a score range of 0-10, with 0=no satisfaction 10=extremely satisfied.

Original Secondary Outcome Measures (submitted: April 26, 2018)

• Adverse events [ Time Frame: 12 months post-operatively ]
  Reporting of adverse events intra- and post-operatively and include adverse events as measured by the Dindo classification system.
• Change in pain [ Time Frame: up to 12 months post-operatively ]
  Pain will be measured on a visual analogue scale for 14 days post-operatively and at 6 weeks and 12 months post-operatively.
• Surgeon satisfaction [ Time Frame: post-operatively up to 12 months ]
  Surgeon satisfaction with the sling will be assessed with a 10-point Likert Scale.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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 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 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description:

Participants and will be masked during the one-year follow-up period.Precautions will be taken to minimize unmasking the study groups: Since RP slings require two suprapubic stab incisions, identical sham incision will also be performed in the SIS group.

Primary Purpose: Treatment

Condition

• Stress Urinary Incontinence
• Pelvic Floor Disorders

Intervention

• Device: RP sling placement
  A 1.5 cm incision will be made at the mid-urethra through a separate vaginal incision with lateral dissection with Metzembaum scissors. After placement of both trocars, cystoscopy with a 70-degree scope will be performed to assess for bladder and urethral injury. Surgeons will set the tension of the tension-free vaginal tape (TVT) slings so that a spacer can be placed between the sling and the urethra. Sling tensioning will be performed after anterior and apical prolapse is corrected.
• Device: SIS placement
  The sling is introduced through a single anterior vaginal incision of 1.5 cm at the mid-urethra. The sling/needle assembly is advanced behind the ischiopubic rami in a transobturator trajectory toward the obturator space bilaterally.The needle is then removed by simply sliding the fixating tip back out. The other side is then completed in an identical fashion. After the fixation of the two anchors at the 2 and 10 o'clock positions, the patient's bladder is filled with 250 mL of NaCl. Afterward, an intraoperative crede maneuver is performed and the tension adjustment suture is pulled, when necessary, to achieve the desired continence. The mesh will lie in direct apposition to the urethra. The adjustment thread is then cut short and the vaginal incision is closed with an absorbable suture.

Study Arms

• Experimental: RP sling group
  Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure.
  Intervention: Device: RP sling placement
• Experimental: SIS group
  Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure.
  Intervention: Device: SIS placement

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 26, 2018): 280
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2023
• Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Sachin Vyas, MS, PhD; 336-713-4098; svyas@wakehealth.edu

Contact: Catherine Matthews, MD; camatthe@wakehealth.edu

• Listed Location Countries: South Africa, United States

Administrative Information

• NCT Number: NCT03520114
• Other Study ID Numbers: IRB00050256
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Wake Forest University Health Sciences
• Study Sponsor: Wake Forest University Health Sciences
• Collaborators: Foundation for Female Health Awareness

Investigators

• Principal Investigator: Catherine Matthews, MD; Wake Forest University Health Sciences

• PRS Account: Wake Forest University Health Sciences
• Verification Date: December 2020