Clinical trial NCT03842410: Solyx Single-Incision SlingDynamic Intraoperative Standing Sling Technique (DISST) as an Office-based Procedure
Official title: Solyx Single-Incision SlingDynamic Intraoperative Standing Sling Technique (DISST) as an Office-based Procedure
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: Michigan Institution of Women's Health PC
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Subject tolerability of the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST)
timeFrame: intraoperative
measure: Surgeon difficulty of performing the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST)
timeFrame: intraoperative
measure: Ability to achieve DISST SUCCESS
timeFrame: intraoperative
measure: Complications of performing the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST)
timeFrame: intraoperative
Secondary outcomes:
measure: Improvement in overall urinary incontinence (stress and urge incontinence)
timeFrame: 3, 6, 12, 24 and 60 months post operative
measure: Sexual function
timeFrame: 3, 6,12, 24 and 60 months post operative
measure: Improvement in patient quality of life as it relates to urinary symptoms
timeFrame: 3, 6,12, 24 and 60 months post operative
measure: Subject satisfaction with overall improvement from sling procedure
timeFrame: 3, 6, 12, 24 and 60 months post operative
measure: Post operative pain
timeFrame: pre-procedure to 7 days after procedure
measure: Post operative complications
timeFrame: post procedure to 12, 24 and 60 months
measure: Return to pre-surgical activities
timeFrame: Pre-procedure to return to 60 months
Other outcomes:
Locations:
city: Dearborn
country: United States
facility: Advanced Urogynecology of Michigan P.C
state: Michigan
Study officials:
affiliation: Advanced Urogynecology of Michigan, P.C.
name: Salil Khandwala, M.D.
role: PRINCIPAL_INVESTIGATOR
References: