NCT03842410

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

May 31, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

January 22, 2024

Status Verified

January 1, 2024

Enrollment Period

10 months

First QC Date

February 7, 2019

Last Update Submit

January 18, 2024

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (4)

  • 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

  • Complications of performing the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST)

    Any intraoperative complications will be documented

    intraoperative

Secondary Outcomes (7)

  • Improvement in overall urinary incontinence (stress and urge incontinence)

    3, 6, 12, 24 and 60 months post operative

  • Sexual function

    3, 6,12, 24 and 60 months post operative

  • Improvement in patient quality of life as it relates to urinary symptoms

    3, 6,12, 24 and 60 months post operative

  • Subject satisfaction with overall improvement from sling procedure

    3, 6, 12, 24 and 60 months post operative

  • Post operative pain

    pre-procedure to 7 days after procedure

  • +2 more secondary outcomes

Study Arms (1)

Single-Incision Sling

OTHER

Intervention with in office solyx suburethral sling DISST

Device: Single-Incision Sling

Interventions

Single-Incision SlingDEVICE

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

Also known as: Solyx Single-incision sling
Single-Incision Sling

Eligibility Criteria

Age18 Years - 89 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advanced Urogynecology of Michigan P.C

Dearborn, Michigan, 48124, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Salil Khandwala, M.D.

    Advanced Urogynecology of Michigan, P.C.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

February 7, 2019

First Posted

February 15, 2019

Study Start

May 31, 2019

Primary Completion

March 15, 2020

Study Completion

March 1, 2025

Last Updated

January 22, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)