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

NCT ID: NCT03842410

Last Updated: 2024-01-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-31
• Study Completion Date: 2025-03-01

Brief Summary

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.

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.

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single-Incision Sling

Intervention with in office solyx suburethral sling DISST

Group Type: OTHER

Single-Incision Sling

Intervention Type: DEVICE

Solyx Single-Incision Sling for correction of stress urinary incontinence done in the office.

Interventions

Single-Incision Sling

Solyx Single-Incision Sling for correction of stress urinary incontinence done in the office.

Intervention Type: DEVICE

Other Intervention Names

Solyx Single-incision sling

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Michigan Institution of Women's Health PC

OTHER

Sponsor Role: lead

Responsible Party

Salil Khandwala

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Salil Khandwala, M.D.

Role: PRINCIPAL_INVESTIGATOR

Advanced Urogynecology of Michigan, P.C.

Locations

Advanced Urogynecology of Michigan P.C

Dearborn, Michigan, United States

Countries

United States

Other Identifiers

ODISST

Identifier Type: -

Identifier Source: org_study_id