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

Sponsor
Michigan Institution of Women's Health PC (Other)
Overall Status
Unknown status
CT.gov ID
NCT03842410
Collaborator
(none)
20
1
18.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Single-Incision Sling
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Solyx Single-Incision SlingDynamic Intraoperative Standing Sling Technique (DISST) as an Office-based Procedure
Anticipated Study Start Date :
Mar 15, 2019
Anticipated Primary Completion Date :
Sep 15, 2020
Anticipated Study Completion Date :
Oct 1, 2020

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Subject tolerability of the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST) [intraoperative]

      Subject tolerability will be assessed using a 10-cm visual analogue scale rating tolerability of the procedure.

    2. Surgeon difficulty of performing the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST) [intraoperative]

      Surgeon difficulty will be determined by a 5-point Likert scale

    3. The feasibility and success of performing the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST) [intraoperative]

      The primary objective of this study is to assess the feasibility and success of performing the Solyx SIMUS procedure in the office setting using the DISST technique . DISST Success will be defined as a negative intraoperative standing cough stress test (CST) at bladder fullness.

    4. Complications of performing the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST) [intraoperative]

      Any intraoperative complications will be documented

    Secondary Outcome Measures

    1. Composite success in correcting stress urinary incontinence [3, 6 and 12 months post operative]

      Secondary outcome objectives will be composite success in correcting SUI, and this will be determined based upon subjective data from the questionnaire Patient Global Impression of Improvement (PGI-I) and objective data (standing cough stress test)

    2. Improvement in overall urinary incontinence (stress and urge incontinence) [6 and 12 months3, 6 and 12 months post operative]

      Subject will complete MESA questionnaire to assess improvement in urge incontinence and stress incontinence

    3. Sexual function [3, 6 and 12 months post operative]

      Subject will complete PISQ-12 questionnaire to assess changes in sexual function.

    4. Improvement in patient quality of life as it relates to urinary symptoms [3, 6 and 12 months post operative]

      Subject will complete IIQ-7 questionnaire to assess changes is quality of life related to urinary symptoms.

    5. Subject satisfaction with overall improvement from sling procedure [3, 6 and 12 months post operative]

      Subject will completed satisfaction questionnaire to determine patients overall satisfaction with the procedure and results

    6. Post operative pain [pre-procedure to 7 days after procedure]

      Post operative pain will be assessed using a McCarthy pain scale questionnaire. This will be completed prior to surgery, the day of, and the 7 days following surgery.

    7. Post operative complications [post procedure to 12 months]

      At post operative visits patients will be asked and assessed for post operative complications

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 89 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Exclusion Criteria:
    • Patient has not completed childbearing

    • ASA classes III or IV

    • Need for concomitant surgery

    • Poor compliance for office-based approach

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Michigan Institution of Women's Health PC

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Salil Khandwala, Director, Michigan Institution of Women's Health PC
    ClinicalTrials.gov Identifier:
    NCT03842410
    Other Study ID Numbers:
    • ODISST
    First Posted:
    Feb 15, 2019
    Last Update Posted:
    Feb 15, 2019
    Last Verified:
    Feb 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 15, 2019