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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

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

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

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

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

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

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

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

Learn more about this trial

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

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