Mixed Urinary IncontinencePhase 4NCT02678377
The SLIM Study: Sling and Botox® Injection for Mixed Urinary Incontinence
A Phase 4 study testing OnabotulinumtoxinA (Botox ®) Injections and Saline Injections in people with Mixed Urinary Incontinence and Stress Urinary Incontinence, run by Northwestern University at 1 site in United States.
Trial summary
This double-blind randomized controlled trial seeks to find a better treatment for women with mixed urinary incontinence (both stress and urgency incontinence). The primary aim is to determine whether midurethral sling surgery combined with injections of onabotulinumtoxinA (Botox®) into the detrusor muscle of the… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mixed Urinary Incontinence, Stress Urinary Incontinence, Urgency Incontinence
- What is being tested?
- OnabotulinumtoxinA (Botox ®) Injections and Saline Injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 26 Jul 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing mid-urethral sling surgery
- Have symptoms of both stress and urgency urinary incontinence
- Able to consent, fill out study documents, and complete all study procedures and follow-up visits
- At least 18 years of age
- English speaking
- Be able and willing to learn clean intermittent self catheterization technique
Who cannot join
- History of recurrent UTI (defined as three culture proven UTIs within last 12 months)
- Systemic neuromuscular disease known to affect the lower urinary tract
- Undergoing concomitant prolapse surgery
- Previous incontinence surgery
- Treatment with anticholinergic medication in the last 2 months
- Previous bladder injection with onabotulinumtoxinA
- Prisoner Status
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Medicine Integrated Pelvic Health Clinic
Chicago, Illinois, 60611
About this study
This double-blind randomized controlled trial seeks to find a better treatment for women with mixed urinary incontinence (both stress and urgency incontinence). The primary aim is to determine whether midurethral sling surgery combined with injections of onabotulinumtoxinA (Botox®) into the detrusor muscle of the bladder improves symptoms of mixed urinary incontinence better than sling surgery alone.
- Being tested
- OnabotulinumtoxinA (Botox ®) Injections, Saline Injections
- 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.
OnabotulinumtoxinA (Botox ®) InjectionsDrug
Also called Botox ®
OnabotulinumtoxinA (Botox ®) is a neurotoxin, which inhibits acetylcholine release and temporarily relaxes the bladder muscle to inhibit urgency incontinence.
Saline InjectionsDrug
Saline will be injected into the bladder so that investigators are masked to subject randomization.
| Study group | Role | What they receive |
|---|---|---|
| OnabotulinumtoxinA injections | Active comparator | 100 units of OnabotulinumtoxinA (Botox®) injected into the detrusor (large muscle of the bladder) at the time of sling surgery. Receives: Drug: OnabotulinumtoxinA (Botox ®) Injections |
| Saline injections | Sham comparator | 100 units of saline injected into the detrusor (large muscle of the bladder) at the time of sling surgery. Receives: Drug: Saline Injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Self-reported Mixed Urinary Incontinence Symptoms
Mixed urinary incontinence symptoms will be assessed by the Patient Global Assessment of Improvement (PGI-I) survey, a patient oriented outcome
Measured: 3 months after surgery
Secondary outcomes (2)
Incontinence Episode Frequency
Incontinence episode frequency will be assessed by a self-report 3-day urinary diary completed by the subject
Measured: 3 months after surgery
Urinary Incontinence Symptoms and Quality of Life
Urinary incontinence symptoms and quality of life will be assessed by a satisfaction survey completed by the subject. The scale is 0-100. and higher scores indicate worse outcomes.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion26 Jul 2021
- Study completion26 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mixed Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Friends of Prentice
- Responsible party
- Principal investigator, Kimberly Kenton, Northwestern University
- Investigators
- Kimberly Kenton, M.D., Principal investigator, Professor, Departments of Obstetrics and Gynecology, Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678377
- Sponsor's protocol ID
- STU00201249
- Status last verified
- Feb 2023
- First submitted
- 5 Feb 2016
- Last updated
- 14 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Komar A, Bretschneider CE, Mueller MG, Lewicky-Gaupp C, Collins S, Geynisman-Tan J, Tavathia M, Kenton K. Concurrent Retropubic Midurethral Sling and OnabotulinumtoxinA for Mixed Urinary Incontinence: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jan 1;137(1):12-20. doi: 10.1097/AOG.0000000000004198.
PubMed 33278293
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SLIM Study: Sling and Botox® Injection for Mixed Urinary Incontinence
- ClinicalTrials.gov ID
- NCT02678377
- Acronym / sponsor ID
- STU00201249
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Friends of Prentice
- Study start
- Feb 2016
- Primary completion
- 26 Jul 2021 (actual)
- Study completion
- 26 Jul 2021 (actual)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Posted 14 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This double-blind randomized controlled trial seeks to find a better treatment for women with mixed urinary incontinence (both stress and urgency incontinence). The primary aim is to determine whether midurethral sling surgery combined with injections of onabotulinumtoxinA (Botox®) into the detrusor muscle of the bladder improves symptoms of mixed urinary incontinence better than sling surgery alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OnabotulinumtoxinA injections | Active comparator | Drug: OnabotulinumtoxinA (Botox ®) Injections100 units of OnabotulinumtoxinA (Botox®) injected into the detrusor (large muscle of the bladder) at the time of sling surgery. |
| Saline injections | Sham comparator | Drug: Saline Injections100 units of saline injected into the detrusor (large muscle of the bladder) at the time of sling surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Undergoing mid-urethral sling surgery
- Have symptoms of both stress and urgency urinary incontinence
- Able to consent, fill out study documents, and complete all study procedures and follow-up visits
- At least 18 years of age
- English speaking
Key exclusion criteria (8 listed)
- History of recurrent UTI (defined as three culture proven UTIs within last 12 months)
- Systemic neuromuscular disease known to affect the lower urinary tract
- Undergoing concomitant prolapse surgery
- Previous incontinence surgery
- Treatment with anticholinergic medication in the last 2 months
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 |
|---|---|---|
| OnabotulinumtoxinA (Botox ®) InjectionsAlso: Botox ®OnabotulinumtoxinA (Botox ®) is a neurotoxin, which inhibits acetylcholine release and temporarily relaxes the bladder muscle to inhibit urgency incontinence. | Drug | OnabotulinumtoxinA injections |
| Saline InjectionsSaline will be injected into the bladder so that investigators are masked to subject randomization. | Drug | Saline injections |
Primary outcome
Number of Participants With Self-reported Mixed Urinary Incontinence Symptoms
Time frame: 3 months after surgery
Mixed urinary incontinence symptoms will be assessed by the Patient Global Assessment of Improvement (PGI-I) survey, a patient oriented outcome
2 secondary outcomes
Incontinence Episode Frequency
Time frame: 3 months after surgery
Urinary Incontinence Symptoms and Quality of Life
Time frame: 3 months after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33278293Komar A, Bretschneider CE, Mueller MG, Lewicky-Gaupp C, Collins S, Geynisman-Tan J, Tavathia M, Kenton K. Concurrent Retropubic Midurethral Sling and OnabotulinumtoxinA for Mixed Urinary Incontinence: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jan 1;137(1):12-20. doi: 10.1097/AOG.0000000000004198.
Related trials for Mixed Urinary Incontinence
Recruiting
Comparing the Effect of Two Types of Pelvic Floor Muscle Stimulation Devices to Improve Symptoms of Urinary Incontinence in Women.
Urinary Incontinence, Mixed Urinary Incontinence
Active, not recruiting
Pelvic Floor Rehabilitation Programme for Women With Urinary Incontinence in a Peruvian Public Hospital
Urinary Incontinence, Urinary Incontinence, Stress
Not yet recruiting
Trial of NASHA Dx Urethral Bulking System
Urinary Incontinence, Urinary Incontinence (UI)
Enrolling by invitation
Magnetic Stimulation as a Treatment for Female Urinary Incontinence
Stress Urinary Incontinence, Urgency Urinary Incontinence
Not yet recruiting
Synchronized Core-Pelvic Floor Activation in Urinary Incontinence
Urinary Incontinence,Stress, Stress Urinary Incontinence
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.
Kimberly Kenton, M.D. principal investigator
Professor, Departments of Obstetrics and Gynecology, Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OnabotulinumtoxinA (Botox ®) Injections and Saline Injections in people with Mixed Urinary Incontinence and Stress Urinary Incontinence, run by Northwestern University 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 8 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: finished, as of the sponsor's last update on 14 Mar 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Self-reported Mixed Urinary Incontinence Symptoms (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02678377, which also lists 1 linked publication.
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 14 Mar 2023.