Stress Urinary IncontinenceNCT03842410
Solyx Single-Incision SlingDynamic Intraoperative Standing Sling Technique (DISST) as an Office-based Procedure
A study testing Single-Incision Sling in people with Stress Urinary Incontinence, run by Michigan Institution of Women's Health PC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Single-Incision Sling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2019to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- ASA classes III or IV
- Need for concomitant surgery
- Poor compliance for office-based approach
- Demonstrate concomitant urgency incontinence on urodynamic testing
Trial locations and contacts
1 site in 1 country.
United States1 site
Advanced Urogynecology of Michigan P.C
Dearborn, Michigan, 48124
About this study
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.
Read the 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.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Single-Incision Sling
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Incision SlingDevice
Also called Solyx Single-incision sling
Solyx Single-Incision Sling for correction of stress urinary incontinence done in the office.
| Study group | Role | What they receive |
|---|---|---|
| Single-Incision Sling | Other | Intervention with in office solyx suburethral sling DISST Receives: Device: Single-Incision Sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: intraoperative
Ability to achieve DISST SUCCESS
Defined as a negative intraoperative standing cough stress test (CST) at bladder fullness.
Measured: intraoperative
Complications of performing the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST)
Any intraoperative complications will be documented
Measured: intraoperative
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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.
Measured: Pre-procedure to return to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start31 May 2019
- Primary completion15 Mar 2020
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michigan Institution of Women's Health PC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salil Khandwala, Michigan Institution of Women's Health PC
- Investigators
- Salil Khandwala, M.D., Principal investigator, Advanced Urogynecology of Michigan, P.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842410
- Sponsor's protocol ID
- ODISST
- Status last verified
- Jan 2024
- First submitted
- 7 Feb 2019
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Solyx Single-Incision SlingDynamic Intraoperative Standing Sling Technique (DISST) as an Office-based Procedure
- ClinicalTrials.gov ID
- NCT03842410
- Acronym / sponsor ID
- ODISST
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Michigan Institution of Women's Health PCUniversity, hospital or other
- Study start
- 31 May 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Incision Sling | Other | Device: Single-Incision SlingIntervention with in office solyx suburethral sling DISST |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- ASA classes III or IV
- Need for concomitant surgery
- Poor compliance for office-based approach
- Demonstrate concomitant urgency incontinence on urodynamic testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-Incision SlingAlso: Solyx Single-incision slingSolyx Single-Incision Sling for correction of stress urinary incontinence done in the office. | Device | Single-Incision Sling |
Primary outcome
Subject tolerability of the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST)
Time frame: intraoperative
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.
Surgeon difficulty of performing the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST)
Time frame: intraoperative
Surgeon difficulty will be determined by a 5-point Likert scale ranging from 1 (very easy) to 5 (very difficult).
Ability to achieve DISST SUCCESS
Time frame: intraoperative
Defined as a negative intraoperative standing cough stress test (CST) at bladder fullness.
Complications of performing the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST)
Time frame: intraoperative
Any intraoperative complications will be documented
7 secondary outcomes
Improvement in overall urinary incontinence (stress and urge incontinence)
Time frame: 3, 6, 12, 24 and 60 months post operative
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
Time frame: 3, 6,12, 24 and 60 months post operative
Subject satisfaction with overall improvement from sling procedure
Time frame: 3, 6, 12, 24 and 60 months post operative
Post operative pain
Time frame: pre-procedure to 7 days after procedure
Post operative complications
Time frame: post procedure to 12, 24 and 60 months
Return to pre-surgical activities
Time frame: Pre-procedure to return to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Stress Urinary Incontinence
RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salil Khandwala, M.D. principal investigator
Advanced Urogynecology of Michigan, P.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-Incision Sling in people with Stress Urinary Incontinence, run by Michigan Institution of Women's Health PC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject tolerability of the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST) (time frame: intraoperative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.