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Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy (SASS)

Primary Purpose

Stress Urinary Incontinence, Pelvic Floor Disorders

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

RP Sling

SIS

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Retropubic Sling, Single-Incision Sling, Sacrocolpopexy

Eligibility Criteria

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

Inclusion Criteria:

At least 21 years of age
Vaginal bulge symptoms as indicated by an affirmative response of >1 to question 3 of the PFDI-SF20
POP ≥ stage II according to the pelvic organ prolapse quantification (POP-Q) system45, with evidence of apical descent
Women being considered for minimally invasive sacrocolpopexy (with or without concomitant hysterectomy)
Objective SUI: positive standardized cough stress test on clinical examination or on urodynamic study with reduced prolapse
Understanding and acceptance of the need to return for all scheduled follow-up visits and willing to complete study questionnaires
Able to give informed consent

Exclusion Criteria:

Prior surgery for stress urinary incontinence including mid-urethral sling; Burch/MMK; fascial pubovaginal sling (autologous, xenograft or allograft); and urethral bulking injection
Any serious disease, or chronic condition, that could interfere with the study compliance
Unwilling to have a synthetic sling
Untreated and unresolved urinary tract infection
Poorly-controlled diabetes mellitus (HgbA1c > 9 within 3 months of surgery date)
Neurogenic bladder/ pre-operative self-catheterization
Elevated post-void residual/PVR (>150 ml) that does not resolve with prolapse reduction testing (pessary, prolapse reduced uroflow or micturition study)
Prior pelvic radiation
Inflammatory bowel disease
Current genitourinary fistula or urethral diverticulum
Planned concomitant bowel related surgery including sphincteroplasty and perineal rectal prolapse surgery, rectovaginal fistula repair, hemorrhoidectomy
Pregnant or Planning to Conceive
Incarcerated

Sites / Locations

Florida Robotic and Minimally Invasive UrogynecologyRecruiting
Augusta UniversityRecruiting
Northwestern MedicineRecruiting
Boston Urogynecology AssociatesRecruiting
Wake Forest Baptist Medical CenterRecruiting
Pelvic Floor Foundation of South Africa, University of Cape TownRecruiting

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

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

Number of participants with subjectively bothersome stress incontinence

Secondary Outcome Measures

VAS (Visual Analogue Scale Surgeon ease of Use)

This will be assessed using the numeric rating scale (NRS). The score is 0-10, with higher scores denoting a greater degree of satisfaction.

Pelvic Organ Prolapse/Urinary Incontinence Sexual Functioning Short Form (PISQ-IR)

Questionnaire consists of 20 questions regarding sexual functioning. PISQ-IR consists of two parts. Part 1, for not Sexually Active (NSA) women, and par 2 for SA women. Response value varies from 1 to 5. Part 1, for not SA (NSA) women, where higher scores indicate a greater impact of the condition on sexual inactivity. Part 2, for SA women, with higher scores indicating better sexual function.

Pelvic Floor Impact (PFIQ-SF7)

Consists of 3 scales with each 7 questions and will be used to assess quality of life regarding pelvic floor related quality of life. The total score is the sum of the three scale score with a range of 0-300. Higher values indicate a greater degree of bother

Patient Global Impression of Improvement (PGI-I)

7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative baseline - lower scores denote improvement - 1= Very much better to 7 = Very much worse

Assessment of post-void residual (PVR) volume

Post Void Residual/PVR measurement - (collected via bladder scan or CIC) (Clean Intermittent Catheterization). PVR can be as minimum as 0ml of an average bladder capacity of 400ml

Number of Participants needing Retreatment

Surgical intervention for urinary retention (sling lysis) at any time point after surgery

Number of Participants needing bladder drainage

Requirement of urinary catheter due to incontinence or retention

Pelvic Floor Distress Inventory (PFDI-SF20)

The PFDI-20 has a total of 20 questions and 3 scales (Urinary Distress Inventory, Pelvic Organ Prolapse Distress Inventory, and Colorectal-Anal Distress Inventory). The outcomes of this questionnaire will be evaluated stratified by compartment. Each item produces a response of 0 to 4, the average response in each scale is multiplied by 25 to obtain the scale score (range 0 to 100). The total score is the sum of the three scale score with a range of 0-300. Higher values indicate a greater degree of bother.

Full Information

NCT ID

NCT04586166

First Posted

October 7, 2020

Last Updated

June 27, 2023

Sponsor

Wake Forest University Health Sciences

Collaborators

Boston Scientific Corporation

1. Study Identification

Unique Protocol Identification Number

NCT04586166

Brief Title

Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy

Acronym

SASS

Official Title

SASS: Randomized Trial of Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for Concomitant Management of Stress Urinary Incontinence During Minimally Invasive Sacrocolpopexy

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 23, 2020 (Actual)

Primary Completion Date

June 2028 (Anticipated)

Study Completion Date

December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

Collaborators

Boston Scientific Corporation

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

SASS (Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy) will be a multicenter, prospective, randomized, single-blind non-inferiority trial.

Detailed Description

SASS aims to compare the efficacy of a single-incision (SIS) versus a retropubic mid-urethral sling (RP) placed at the time of minimally invasive sacrocolpopexy in women with pelvic organ prolapse and objectively confirmed stress urinary incontinence (SUI).

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, Sacrocolpopexy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Masking Description

Participants will be masked during the five-year follow-up period. Precautions will be taken to minimize unmasking the study groups. Since RP (retropubic) slings require two suprapubic stab incisions, identical sham incision will also be performed in the SIS (Single-Incision Sling) group.

Allocation

Randomized

Enrollment

180 (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

Other Intervention Name(s)

Advantage RP Sling

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

SIS

Other Intervention Name(s)

Solyx SIS System

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of participants with subjectively bothersome stress incontinence

Description

Time Frame

6 weeks after surgery

Title

Number of participants with subjectively bothersome stress incontinence

Description

Time Frame

1 year after surgery

Title

Number of participants with subjectively bothersome stress incontinence

Description

Time Frame

3 years after surgery

Title

Number of participants with subjectively bothersome stress incontinence

Description

Time Frame

5 years after surgery

Secondary Outcome Measure Information:

Title

VAS (Visual Analogue Scale Surgeon ease of Use)

Description

This will be assessed using the numeric rating scale (NRS). The score is 0-10, with higher scores denoting a greater degree of satisfaction.

Time Frame

Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5

Title

Pelvic Organ Prolapse/Urinary Incontinence Sexual Functioning Short Form (PISQ-IR)

Description

Time Frame

Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5

Title

Pelvic Floor Impact (PFIQ-SF7)

Description

Time Frame

Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5

Title

Patient Global Impression of Improvement (PGI-I)

Description

Time Frame

Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5

Title

Assessment of post-void residual (PVR) volume

Description

Post Void Residual/PVR measurement - (collected via bladder scan or CIC) (Clean Intermittent Catheterization). PVR can be as minimum as 0ml of an average bladder capacity of 400ml

Time Frame

Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5

Title

Number of Participants needing Retreatment

Description

Surgical intervention for urinary retention (sling lysis) at any time point after surgery

Time Frame

6 month up to 5 year post-surgery

Title

Number of Participants needing bladder drainage

Description

Requirement of urinary catheter due to incontinence or retention

Time Frame

beyond 6 weeks post-surgery

Title

Pelvic Floor Distress Inventory (PFDI-SF20)

Description

Time Frame

Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Female patients with pelvic organ prolapse.

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: At least 21 years of age Vaginal bulge symptoms as indicated by an affirmative response of >1 to question 3 of the PFDI-SF20 POP ≥ stage II according to the pelvic organ prolapse quantification (POP-Q) system45, with evidence of apical descent Women being considered for minimally invasive sacrocolpopexy (with or without concomitant hysterectomy) Objective SUI: positive standardized cough stress test on clinical examination or on urodynamic study with reduced prolapse Understanding and acceptance of the need to return for all scheduled follow-up visits and willing to complete study questionnaires Able to give informed consent Exclusion Criteria: Prior surgery for stress urinary incontinence including mid-urethral sling; Burch/MMK; fascial pubovaginal sling (autologous, xenograft or allograft); and urethral bulking injection Any serious disease, or chronic condition, that could interfere with the study compliance Unwilling to have a synthetic sling Untreated and unresolved urinary tract infection Poorly-controlled diabetes mellitus (HgbA1c > 9 within 3 months of surgery date) Neurogenic bladder/ pre-operative self-catheterization Elevated post-void residual/PVR (>150 ml) that does not resolve with prolapse reduction testing (pessary, prolapse reduced uroflow or micturition study) Prior pelvic radiation Inflammatory bowel disease Current genitourinary fistula or urethral diverticulum Planned concomitant bowel related surgery including sphincteroplasty and perineal rectal prolapse surgery, rectovaginal fistula repair, hemorrhoidectomy Pregnant or Planning to Conceive Incarcerated

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sachin N Vyas, MS,PhD

Phone

336-713-4098

svyas@wakehealth.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Catherine A Matthews, MD

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Catherine A Matthews, MD

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Florida Robotic and Minimally Invasive Urogynecology

City

Coconut Creek

State/Province

Florida

ZIP/Postal Code

33073

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karen Brocki

Phone

954-570-7644

Facility Name

Augusta University

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Torri Blackmon

Phone

706-721-1088

TBlackm2@augusta.edu

First Name & Middle Initial & Last Name & Degree

Jennifer Lanzer, MD

Facility Name

Northwestern Medicine

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sophia Kallas, BS, BA, BMS

Phone

312-926-7846

sophia.kallas@nm.org

First Name & Middle Initial & Last Name & Degree

Julia Geynisman-Tan, MD

Facility Name

Boston Urogynecology Associates

City

Cambridge

State/Province

Massachusetts

ZIP/Postal Code

02138

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peter L Rosenblatt

Phone

617-354-5452

First Name & Middle Initial & Last Name & Degree

Peter L Rosenblatt, MD

Facility Name

Wake Forest Baptist Medical Center

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27101

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sachin N Vyas, MS,PhD

Phone

336-713-4098

First Name & Middle Initial & Last Name & Degree

Catherine A Matthews, MD

Facility Name

Pelvic Floor Foundation of South Africa, University of Cape Town

City

Cape Town

ZIP/Postal Code

8001

Country

South Africa

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christelle De Koker

Phone

27-64-650-6199

christelle.dekoker@uct.ac.za

First Name & Middle Initial & Last Name & Degree

Stephen Jeffery, MD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Only limited dataset without PHI will be shared with the study bio statistical group.

Learn more about this trial

Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy

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