Retropubic vs. Single-Incision Mid-Urethral Sling for Stress Urinary Incontinence
Primary Purpose
Stress Urinary Incontinence, Pelvic Floor Disorders
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RP sling placement
SIS placement
Sponsored by
![Wake Forest University Health Sciences](https://trials-media.s3.amazonaws.com/orgs/wake-forest-university-health-sciences.jpeg)
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Retropubic sling, Single-incision sling, Vaginal repair, Management
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.
Sites / Locations
- MedStar Health/National Center for Advance Pelvic Surgery
- Northwestern Medical Group
- Northwell Health
- Wake Forest Baptist Medical Center
- Cleveland Clinic
- Women & Infants Hospital of Rhode Island
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
RP sling group
SIS group
Arm Description
Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure.
Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure.
Outcomes
Primary Outcome Measures
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
Retreatment for stress incontinence
This includes pelvic floor physical therapy; incontinence pessary; urethral bulking injection; repeat incontinence surgery.
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
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..
Surgical intervention for urinary retention
Sling lysis or revision at any time point post-operatively up to 12 Month post-operatively.
Secondary Outcome Measures
Adverse events
Reporting of adverse events intra- and post-operatively and include adverse events as measured by the Dindo classification system.
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 .
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.
Full Information
NCT ID
NCT03520114
First Posted
April 26, 2018
Last Updated
September 26, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
Foundation for Female Health Awareness
1. Study Identification
Unique Protocol Identification Number
NCT03520114
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 12, 2018 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Foundation for Female Health Awareness
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence, Pelvic Floor Disorders
Keywords
Retropubic sling, Single-incision sling, Vaginal repair, Management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
280 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RP sling group
Arm Type
Experimental
Arm Description
Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure.
Arm Title
SIS group
Arm Type
Experimental
Arm Description
Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure.
Intervention Type
Device
Intervention Name(s)
RP sling placement
Intervention Description
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
Intervention Name(s)
SIS placement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with subjectively bothersome stress incontinence
Description
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
Time Frame
12 months post-operatively
Title
Retreatment for stress incontinence
Description
This includes pelvic floor physical therapy; incontinence pessary; urethral bulking injection; repeat incontinence surgery.
Time Frame
12 months post-operatively
Title
De novo or worsening urge incontinence symptoms
Description
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
Time Frame
12 months post-operatively
Title
Requirement for bladder drainage
Description
Beyond 2 weeks post-operatively with PVR > 150 ml OR > 1/3 total voided volume up to 12 Month post-operatively..
Time Frame
12 Month post-operatively
Title
Surgical intervention for urinary retention
Description
Sling lysis or revision at any time point post-operatively up to 12 Month post-operatively.
Time Frame
12 Month post-operatively
Secondary Outcome Measure Information:
Title
Adverse events
Description
Reporting of adverse events intra- and post-operatively and include adverse events as measured by the Dindo classification system.
Time Frame
12 months post-operatively
Title
Change in pain
Description
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 .
Time Frame
up to 12 months post-operatively
Title
Surgeon satisfaction
Description
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.
Time Frame
post-operatively up to 12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Matthews, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedStar Health/National Center for Advance Pelvic Surgery
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Northwestern Medical Group
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Northwell Health
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Women & Infants Hospital of Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Retropubic vs. Single-Incision Mid-Urethral Sling for Stress Urinary Incontinence
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