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

Stress Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03520114
• Other study ID #: IRB00050256
• Status: Completed
• Phase: N/A
• Start date: December 12, 2018
• Est. completion date: January 2, 2024

Study information

• Verified date: September 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: January 2, 2024
• Est. primary completion date: January 2, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Pelvic Floor Disorders
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

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.
• 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 Sodium Chloride (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.

Locations

Country	Name	City	State
United States	Northwestern Medical Group	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Northwell Health	Manhasset	New York
United States	Women & Infants Hospital of Rhode Island	Providence	Rhode Island
United States	MedStar Health/National Center for Advance Pelvic Surgery	Washington	District of Columbia
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Foundation for Female Health Awareness

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with subjectively bothersome stress incontinence	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	12 months post-operatively
Primary	Retreatment for stress incontinence	This includes pelvic floor physical therapy; incontinence pessary; urethral bulking injection; repeat incontinence surgery.	12 months post-operatively
Primary	De novo or worsening urge incontinence symptoms	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	12 months post-operatively
Primary	Requirement for bladder drainage	Beyond 2 weeks post-operatively with PVR > 150 ml OR > 1/3 total voided volume up to 12 Month post-operatively..	12 Month post-operatively
Primary	Surgical intervention for urinary retention	Sling lysis or revision at any time point post-operatively up to 12 Month post-operatively.	12 Month post-operatively
Secondary	Adverse events	Reporting of adverse events intra- and post-operatively and include adverse events as measured by the Dindo classification system.	12 months post-operatively
Secondary	Change in pain	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 .	up to 12 months post-operatively
Secondary	Surgeon satisfaction	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.	post-operatively up to 12 months