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

NCT03520114 | Completed Results DMC FDA Device

• 1 other identifier: IRB00050256
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 6

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.

Conditions

Stress Urinary Incontinence; Pelvic Floor Disorders

Keywords

Retropubic sling; Single-incision sling; Vaginal repair; Management

Outcome Measures

Primary Outcomes (5)

• 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

• Count of Participants Needing Retreatment for Stress Incontinence

  This includes pelvic floor physical therapy; incontinence pessary; urethral bulking injection; repeat incontinence surgery.

  12 months post-operatively

• Count of Participants With 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

• Count of Participants Requiring 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

• Count of Participants Needing 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 Outcomes (2)

• Number of Participants With Adverse Events

  12 months post-operatively

• Surgeon Satisfaction Scores

  post-operatively up to 12 months

Study Arms (2)

RP sling group

EXPERIMENTAL

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

Device: RP sling placement

SIS group

EXPERIMENTAL

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

Device: SIS placement

Interventions

RP sling placement 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.

RP sling group

SIS placement 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.

SIS group

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Foundation for Female Health Awareness: collaborator

Study Sites (6)

MedStar Health/National Center for Advance Pelvic Surgery

Washington D.C., District of Columbia, 20010, United States

Location

Northwestern Medical Group

Chicago, Illinois, 60611, United States

Location

Northwell Health

Manhasset, New York, 11030, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02903, United States

Location

Related Publications (3)

• 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.

  PMID: 39689213 DERIVED

• 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.

  PMID: 38705225 DERIVED

• 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.

  PMID: 37888839 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress; Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications

Results Point of Contact

• Title: Sachin Nalin Vyas, MS,PhD
• Organization: Wake Forest University

svyas@wakehealth.edu

336-713-4098

Study Officials

• Catherine Matthews, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 9, 2018
• Study Start: December 12, 2018
• Primary Completion: January 2, 2024
• Study Completion: January 2, 2024
• Last Updated: January 16, 2025
• Results First Posted: January 16, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)