- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03520114
Retropubic vs. Single-Incision Mid-Urethral Sling for Stress Urinary Incontinence
March 5, 2024 updated by: Wake Forest University Health Sciences
Randomized Trial of Retropubic Versus Single-incision Mid-Urethral Sling (Altis ) for Concomitant Management of Stress Urinary Incontinence During Native Tissue Vaginal Repair
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
280
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Catherine Matthews, MD
- Email: camatthe@wakehealth.edu
Study Contact Backup
- Name: Sachin Vyas, MS, PhD
- Phone Number: 336-713-4098
- Email: svyas@wakehealth.edu
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20010
- MedStar Health/National Center for Advance Pelvic Surgery
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern Medical Group
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New York
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Manhasset, New York, United States, 11030
- Northwell Health
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest Baptist Medical Center
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Women & Infants Hospital of Rhode Island
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RP sling group
Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure.
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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.
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Experimental: SIS group
Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with subjectively bothersome stress incontinence
Time Frame: 12 months post-operatively
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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
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12 months post-operatively
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Retreatment for stress incontinence
Time Frame: 12 months post-operatively
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This includes pelvic floor physical therapy; incontinence pessary; urethral bulking injection; repeat incontinence surgery.
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12 months post-operatively
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De novo or worsening urge incontinence symptoms
Time Frame: 12 months post-operatively
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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
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12 months post-operatively
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Requirement for bladder drainage
Time Frame: 12 Month post-operatively
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Beyond 2 weeks post-operatively with PVR > 150 ml OR > 1/3 total voided volume up to 12 Month post-operatively..
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12 Month post-operatively
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Surgical intervention for urinary retention
Time Frame: 12 Month post-operatively
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Sling lysis or revision at any time point post-operatively up to 12 Month post-operatively.
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12 Month post-operatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events
Time Frame: 12 months post-operatively
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Reporting of adverse events intra- and post-operatively and include adverse events as measured by the Dindo classification system.
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12 months post-operatively
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Change in pain
Time Frame: up to 12 months post-operatively
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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 .
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up to 12 months post-operatively
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Surgeon satisfaction
Time Frame: post-operatively up to 12 months
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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.
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post-operatively up to 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Catherine Matthews, MD, Wake Forest University Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 12, 2018
Primary Completion (Actual)
January 2, 2024
Study Completion (Actual)
January 2, 2024
Study Registration Dates
First Submitted
April 26, 2018
First Submitted That Met QC Criteria
April 26, 2018
First Posted (Actual)
May 9, 2018
Study Record Updates
Last Update Posted (Actual)
March 7, 2024
Last Update Submitted That Met QC Criteria
March 5, 2024
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Urologic Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urination Disorders
- Pregnancy Complications
- Elimination Disorders
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Urinary Incontinence
- Enuresis
- Urinary Incontinence, Stress
- Pelvic Floor Disorders
Other Study ID Numbers
- IRB00050256
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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