Solyx Single-Incision SlingDynamic Intraoperative Standing Sling Technique (DISST) as an Office-based Procedure

This study will assess the feasibility and success of performing the SolyxTM SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISSTTM). Study endpoints will be feasibility, composite success, complications, and patient and physician acceptance.

Study Overview

• Status: Active, not recruiting
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: Single-Incision Sling

Detailed Description

The single-incision midurethral sling (SIMUS) is a procedure where there are no exit incisions. There is a 15 mm suburethral incision with the sling being attached with anchors to the obturator muscle on each side. This procedure has potentially lesser side-effects compared to the longer slings however, the literature has not found the SIMUS to be as effective as the long slings. In our recently published study, the DISSTTM technique has significantly improved the success of the SIMUS procedure as the sling can be tested for proper application in vivo.

As we have performed several of these procedures in the operating room entirely under local anesthesia, we have decided to perform this procedure in an office setting using the same safety precautions as in a hospital operating room.

Performing this procedure in the office has significant benefits for the patient, the healthcare industry, and the economy overall. Moving away from a hospital setting has significant psychological benefits. This will increase patient acceptance and therefore will become appealing to many more women who may be shying away from treatment.

It would also eliminate the risk of nosocomial infections for the patient and family members, improve efficiency as the wait time would be negligible, and would reduce the expense of the entire treatment as hospital costs would not feature in the equation.

This study will assess the feasibility and success of performing the SolyxTM SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISSTTM). Study endpoints will be feasibility, composite success, complications, and patient and physician acceptance.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Dearborn, Michigan, United States, 48124
      • Advanced Urogynecology of Michigan P.C

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• SUI with hypermobility of the urethrovesical (UV) junction
• American Society of Anesthesiologists (ASA) classes I or II
• Ages ranging 21-89 years
• Have the ability to stand for CST during the procedure
• Have failed behavioral therapy
• Completed childbearing

Exclusion Criteria:

• ASA classes III or IV
• Need for concomitant surgery
• Poor compliance for office-based approach
• Demonstrate concomitant urgency incontinence on urodynamic testing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single-Incision Sling; Intervention with in office solyx suburethral sling DISST	Device: Single-Incision Sling; Solyx Single-Incision Sling for correction of stress urinary incontinence done in the office.; Other Names: Solyx Single-incision sling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications of performing the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST)	Any intraoperative complications will be documented	intraoperative
Subject tolerability of the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST)	Subject tolerability will be assessed using a 10-cm Visual Analogue Scale rating tolerability of the procedure. The Visual Analog Scale measures discomfort of the procedure with 0 being no discomfort and 10 being severe discomfort.	intraoperative
Surgeon difficulty of performing the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST)	Surgeon difficulty will be determined by a 5-point Likert scale ranging from 1 (very easy) to 5 (very difficult).	intraoperative
Ability to achieve DISST SUCCESS	Defined as a negative intraoperative standing cough stress test (CST) at bladder fullness.	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in overall urinary incontinence (stress and urge incontinence)	Subject will complete the Medical, Epidemiologic, and Social Aspects of Aging (MESA) urinary incontinence questionnaire to assess improvement in urge incontinence and stress incontinence. Subjects will also complete the Patient Global Impression of Improvement (PGI-I) questionnaire as it pertains to stress urinary incontinence.	3, 6, 12, 24 and 60 months post operative
Sexual function	Subject will complete the Pelvic Organ Prolapse/Urinary Incontinence Sexual (PISQ-12) questionnaire to assess changes in sexual function.	3, 6,12, 24 and 60 months post operative
Improvement in patient quality of life as it relates to urinary symptoms	Subject will complete Incontinence Impact Questionnaire (IIQ-7) to assess changes in quality of life related to urinary symptoms.	3, 6,12, 24 and 60 months post operative
Subject satisfaction with overall improvement from sling procedure	Subject will completed satisfaction questionnaire to determine patients overall satisfaction with the procedure and results	3, 6, 12, 24 and 60 months post operative
Post operative pain	Post operative pain will be assessed using a McCarthy pain scale questionnaire, which ranges from "No Pain Sensation" to "Most Intense Pain Sensation Imaginable". Pain will be assessed at rest, during daily activities, during sex, lifting, or other strenuous work in the last 24 hours. This will be completed prior to surgery, the day of, and the 7 days following surgery.	pre-procedure to 7 days after procedure
Post operative complications	At post operative visits patients will be asked and assessed for post operative complications (based upon the Clavien Dindo classification)	post procedure to 12, 24 and 60 months
Return to pre-surgical activities	Patients will be asked what activities they engage in prior to surgery including work, exercise, social, and household activities. At each post operative visit the patient will be asked when they returned to pre-surgical activities.	Pre-procedure to return to 60 months

Collaborators and Investigators

• Sponsor: Michigan Institution of Women's Health PC
• Investigators: Principal Investigator: Salil Khandwala, M.D., Advanced Urogynecology of Michigan, P.C.

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2019
• Primary Completion (Actual): March 15, 2020
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: February 7, 2019
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Urinary Incontinence, Stress
• Other Study ID Numbers: ODISST

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