An interventional study of Single-Incision Sling in Stress Urinary Incontinence, sponsored by Michigan Institution of Women's Health PC. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-22.
Sponsored by Michigan Institution of Women's Health PC · Not applicable, Interventional, and Treatment
Among 189 studies in Urinary Incontinence, Stress with a site in United States — 27 open to participants now, 40 under way, 3 of them phase 3. Urinary Incontinence, Stress · United States.
Among the 189 studies in Urinary Incontinence, Stress with a site in United States, this one is the 140th largest by planned enrollment of the 163 interventional ones that give a count, is one of 17 that started in 2019, is one of 109 with no phase, reaches primary completion later than 0 of the 39 other live ones, and was the 115th registered.
653 studies on the registry are indexed under Urinary Incontinence, Stress; 121 are open to participants now.
Browse Urinary Incontinence, Stress studies →27 of the 189 studies in Urinary Incontinence, Stress with a site in United States are open now. Recruiting first, the newest first:
University of Miami · Sites in United States
Ages 18+ · Women only
Mayo Clinic · Sites in United States
Ages 18+ · Women only · Healthy volunteers
Eli Lilly and Company · Sites in United States, Canada, China and 6 more countries
Ages 18+ · Women only
Ohio State University · Sites in United States
Ages 18–50 · Women only
University of Rochester · Sites in United States
Ages 18+ · Men only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 74 Urinary Incontinence, Stress studies recruiting now, 42 (57%) set no upper age limit and 18 (24%) stop at 75 or younger; 2 take children under 18; 16 take healthy volunteers.
This study: 18 Years to 89 Years · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
189 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 18 · Phase 3 23 · Phase 4 15
First in 2001; this study’s year is marked. 17 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 68 across 508 interventional studies indexed under Urinary Incontinence, Stress.
Median enrollment 98 across the 163 interventional studies, 98 across the 26 observational. Of the 129 that completed or were terminated, 56 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
72 of 189 have an industry lead sponsor. The 10 most frequent:
Michigan Institution of Women's Health PC is the lead sponsor of 8 studies on the registry; none are open to participants now.
Michigan Institution of Women's Health PC has 3 studies filed under Urinary Incontinence, Stress — fewer than ten, so there is no comparison to draw.
9 of the studies in Urinary Incontinence, Stress with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06968741UroMems SASA Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS) | 2026-12 |
| NCT06111209Brigham and Women's HospitalThe Anabolic Effect of Testosterone on Pelvic Floor Muscles | 2026-12-31 |
| NCT06369922University of RochesterTENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence. | 2027-01-31 |
| NCT06706362Ohio State UniversityAssessing the Utility of Prophylactic Antibiotics at Time of Urethral Bulking Using Bulkamid (Bulkamid Study) | 2027-04-15 |
| NCT07008898University of Alabama at BirminghamSequence of Midurethral Sling Placement During Robotic Sacrocolpopexy | 2027-05 |
Add all 9 to your calendar (.ics) → With an account.
Among the 189 studies in Urinary Incontinence, Stress with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: Solyx Single-incision sling
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.
Time frame: 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).
Time frame: intraoperative
Ability to achieve DISST SUCCESS
Defined as a negative intraoperative standing cough stress test (CST) at bladder fullness.
Time frame: intraoperative
Complications of performing the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST)
Any intraoperative complications will be documented
Time frame: intraoperative
Improvement in overall urinary incontinence (stress and urge incontinence)
Subject will complete the Medical, Epidemiologic, and Social Aspects of Aging (MESA) urinary incontinence questionnaire to assess improvement in urge incontinence and stress incontinence. Subjects will also complete the Patient Global Impression of Improvement (PGI-I) questionnaire as it pertains to stress urinary incontinence.
Time frame: 3, 6, 12, 24 and 60 months post operative
Sexual function
Subject will complete the Pelvic Organ Prolapse/Urinary Incontinence Sexual (PISQ-12) questionnaire to assess changes in sexual function.
Time frame: 3, 6,12, 24 and 60 months post operative
Improvement in patient quality of life as it relates to urinary symptoms
Subject will complete Incontinence Impact Questionnaire (IIQ-7) to assess changes in quality of life related to urinary symptoms.
Time frame: 3, 6,12, 24 and 60 months post operative
Subject satisfaction with overall improvement from sling procedure
Subject will completed satisfaction questionnaire to determine patients overall satisfaction with the procedure and results
Time frame: 3, 6, 12, 24 and 60 months post operative
Post operative pain
Post operative pain will be assessed using a McCarthy pain scale questionnaire, which ranges from "No Pain Sensation" to "Most Intense Pain Sensation Imaginable". Pain will be assessed at rest, during daily activities, during sex, lifting, or other strenuous work in the last 24 hours. This will be completed prior to surgery, the day of, and the 7 days following surgery.
Time frame: pre-procedure to 7 days after procedure
Post operative complications
At post operative visits patients will be asked and assessed for post operative complications (based upon the Clavien Dindo classification)
Time frame: post procedure to 12, 24 and 60 months
Return to pre-surgical activities
Patients will be asked what activities they engage in prior to surgery including work, exercise, social, and household activities. At each post operative visit the patient will be asked when they returned to pre-surgical activities.
Time frame: Pre-procedure to return to 60 months
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2019 to primary completion in Mar 2020, 9 months.
Of 226 non-industry interventional studies with no phase under Urinary Incontinence, Stress, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 9 months is below that.
Counting every sponsor, half of 267 studies reached it within 19 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Urinary Incontinence, Stress →
Michigan Institution of Women's Health PC