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

NCT03842410 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-01-22

No results posted yet for this study

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.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

Single-Incision Sling

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

Sponsors & Collaborators

  • Michigan Institution of Women's Health PC

    lead OTHER

Principal Investigators

  • Salil Khandwala, M.D. · Advanced Urogynecology of Michigan, P.C.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-31
Primary Completion
2020-03-15
Completion
2025-03-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03842410 on ClinicalTrials.gov