Stress Urinary IncontinenceDISSTNCT03120117
Importance of Patient Positioning at Cough Test When Considering Success Following Sling Procedures
A study testing Cough Test following Sling Surgery in people with Stress Urinary Incontinence, run by Michigan Institution of Women's Health PC at 1 site in United States.
Trial summary
This is a prospective study to assess the feasibility and success of performing an intra-operative standing cough test and the correlation with the long term success of the sling surgery. Read more about this study
- Who is it for?
- Ages 21 to 89 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Cough Test following Sling Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jan 2018
- 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 21 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who present with stress-dominant urinary incontinence
- Patients who have undergone a stress test documentation both in the supine and standing/sitting position.
- Patients who have completed child bearing.
- Patients between 21 and 89 years of age.
Who cannot join
- Patients who do not agree to participate and do not sign the informed consent.
- Patients undergoing concomitant surgery
- Patients undergoing surgery under anesthesia.
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 is a prospective study to assess the feasibility and success of performing an intra-operative standing cough test and the correlation with the long term success of the sling surgery.
Read the detailed description
The goal is to seek correlation or disparity between the supine versus the sitting cough test, supine (lying down) versus standing cough test and sitting versus the standing cough test performed at a constant bladder volume; empty in the office and full in the operating room. Secondary objective is to test if the intra-operative standing cough test at fullness correlates with long term success of the sling surgery.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Cough Test following Sling Surgery
- Keywords
- Midurethral Slings
- 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.
Cough Test following Sling SurgeryProcedure or surgery
Also called DISST Procedure
Enrolled subjects will undergo sling surgery who present with stress-dominated urinary incontinence. While in the operating room, the subject will be asked to stand and cough to determine if there is still leakage once the sling has been placed.
| Study group | Role | What they receive |
|---|---|---|
| Cough Test following Sling Surgery | Experimental | All subjects enrolled will undergo sling surgery for treatment of stress urinary incontinence and subsequently asked to do a standing cough test. Receives: Procedure: Cough Test following Sling Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who present with recurrence of stress incontinence following sling surgery as assessed by post-operative cough test.
Success criteria will be defined through the examination of patient's post-operative visits regarding cough stress tests in supine, sitting and standing positions where the bladder is at 10% of urodynamic fullness. Failure to meet this criteria will be considered recurrence of stress incontinence.
Measured: Within first two years following sling procedure
Number of patients who present with recurrence of stress incontinence following sling surgery as assessed by post-operative MESA questionnaire.
Success criteria is also defined through the examination of patient's response to Medical Epidemiologic and Social Aspects of Aging 12 (MESA) to determine recurrence of stress incontinence. Failure to meet this criteria will be considered recurrence of stress incontinence.
Measured: Within first two years following sling procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study startAug 2013
- Primary completionDec 2017 (estimated)
- Study completionJan 2018 (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
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan Institution of Women's Health PC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salil Khandwala MD, Michigan Institution of Women's Health PC
- Investigators
- Salil Khandwala, MD, Principal investigator, Michigan Institute of Women's Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120117
- Sponsor's protocol ID
- MIWH13-001
- Acronym
- DISST
- Status last verified
- Apr 2017
- First submitted
- 14 Apr 2017
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Importance of Patient Positioning at Cough Test When Considering Success Following Sling Procedures
- ClinicalTrials.gov ID
- NCT03120117
- Acronym / sponsor ID
- DISST / MIWH13-001
- Conditions
- Stress Urinary Incontinence
- Keywords
- Midurethral Slings
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Michigan Institution of Women's Health PCUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 19 Apr 2017 (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 is a prospective study to assess the feasibility and success of performing an intra-operative standing cough test and the correlation with the long term success of the sling surgery.
Detailed description
The goal is to seek correlation or disparity between the supine versus the sitting cough test, supine (lying down) versus standing cough test and sitting versus the standing cough test performed at a constant bladder volume; empty in the office and full in the operating room. Secondary objective is to test if the intra-operative standing cough test at fullness correlates with long term success of the sling surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cough Test following Sling Surgery | Experimental | Procedure: Cough Test following Sling SurgeryAll subjects enrolled will undergo sling surgery for treatment of stress urinary incontinence and subsequently asked to do a standing cough test. |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who present with stress-dominant urinary incontinence
- Patients who have undergone a stress test documentation both in the supine and standing/sitting position.
- Patients who have completed child bearing.
- Patients between 21 and 89 years of age.
Key exclusion criteria (3 listed)
- Patients who do not agree to participate and do not sign the informed consent.
- Patients undergoing concomitant surgery
- Patients undergoing surgery under anesthesia.
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 |
|---|---|---|
| Cough Test following Sling SurgeryAlso: DISST ProcedureEnrolled subjects will undergo sling surgery who present with stress-dominated urinary incontinence. While in the operating room, the subject will be asked to stand and cough to determine if there is still leakage once the sling has been placed. | Procedure or surgery | Cough Test following Sling Surgery |
Primary outcome
Number of patients who present with recurrence of stress incontinence following sling surgery as assessed by post-operative cough test.
Time frame: Within first two years following sling procedure
Success criteria will be defined through the examination of patient's post-operative visits regarding cough stress tests in supine, sitting and standing positions where the bladder is at 10% of urodynamic fullness. Failure to meet this criteria will be considered recurrence of stress incontinence.
Number of patients who present with recurrence of stress incontinence following sling surgery as assessed by post-operative MESA questionnaire.
Time frame: Within first two years following sling procedure
Success criteria is also defined through the examination of patient's response to Medical Epidemiologic and Social Aspects of Aging 12 (MESA) to determine recurrence of stress incontinence. Failure to meet this criteria will be considered recurrence of stress incontinence.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
- Individual participant dataSharing planned: No
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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, MD principal investigator
Michigan Institute of Women's Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cough Test following Sling Surgery 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 4 inclusion and 3 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 19 Apr 2017. 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?
Number of patients who present with recurrence of stress incontinence following sling surgery as assessed by post-operative cough test. (time frame: Within first two years following sling procedure). The study lists 2 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 19 Apr 2017.