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

NCT ID: NCT03520114

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-12
• Study Completion Date: 2024-01-02

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.

Conditions

Stress Urinary Incontinence; Pelvic Floor Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

RP sling group

Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure.

Group Type: EXPERIMENTAL

RP sling placement

Intervention Type: DEVICE

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 group

Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure.

Group Type: EXPERIMENTAL

SIS placement

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Foundation for Female Health Awareness

OTHER

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine Matthews, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

MedStar Health/National Center for Advance Pelvic Surgery

Washington D.C., District of Columbia, United States

Northwestern Medical Group

Chicago, Illinois, United States

Northwell Health

Manhasset, New York, United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, United States

Countries

United States

References

Mezes CM, Russell GB, Gutman RE, Iglesia C, Rardin C, Kenton K, Collins S, Matthews CA. Effect of Vaginal Prolapse Repair and Midurethral Sling on Urgency Incontinence Symptoms. Urogynecology (Phila). 2025 Mar 1;31(3):250-257. doi: 10.1097/SPV.0000000000001620. Epub 2024 Dec 13.

Reference Type: DERIVED

PMID: 39689213 (View on PubMed)

Matthews CA, Rardin CR, Sokol A, Iglesia C, Collins S, Ferrando C, Winkler H, Kenton K, Geynisman-Tan J, Gutman RE. A randomized trial of retropubic vs single-incision sling among patients undergoing vaginal prolapse repair. Am J Obstet Gynecol. 2024 Aug;231(2):261.e1-261.e10. doi: 10.1016/j.ajog.2024.04.036. Epub 2024 May 3.

Reference Type: DERIVED

PMID: 38705225 (View on PubMed)

Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.

Reference Type: DERIVED

PMID: 37888839 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00050256

Identifier Type: -

Identifier Source: org_study_id