Urinary Incontinence, StressNCT02599051
Transobturator Verus Single Incision Slings
A study testing Mini-arc and Monarc in people with Urinary Incontinence, Stress, run by Cecilia Calvo.
Trial summary
A randomized control trial to compare the efficacy of the single incision mini-sling to the transobturator sling Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, Stress
- What is being tested?
- Mini-arc and Monarc
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Jan 2011
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with urodynamically proven stress urinary incontinence who were planning on undergoing surgery for treatment.
Who cannot join
- Patients with prior incontinence surgery, a urodynamic diagnosis of intrinsic sphincter deficiency and mixed incontinence with a predominance of detrusor overactivity were excluded.
About this study
Official title: Transobturator Versus Single Incision Slings: 1 Year Results of a Randomized Control Trial
A randomized control trial to compare the efficacy of the single incision mini-sling to the transobturator sling
Read the detailed description
Transobturator slings are one type of sling that has become standard treatment for stress urinary incontinence. However, this procedure involves a total of 3 incisions to perform.
In contrast, single incision slings have been developed to treat stress urinary incontinence by using only one incision.
However, to date the success and complications of these two procedures have not been compared or studied.
- Conditions
- Urinary Incontinence, Stress
- Being tested
- Mini-arc, Monarc
- 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.
Mini-arcDevice
Also called single incision sling
We will place a single incision sling at the time of surgery for stress urinary incontinence
MonarcDevice
Also called transobturator sling
We will place a transobturator sling at the time of surgery for stress urinary incontinence
| Study group | Role | What they receive |
|---|---|---|
| Monarc | Active comparator | Placement of a transobturator monarc sling for stress urinary incontinence Receives: Device: Monarc |
| Mini-arc | Experimental | Placement of a single incision mini-arc sling for stress urinary incontinence Receives: Device: Mini-arc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Stress Urinary Incontinence
The primary outcome was presence of leakage during cough stress test(CST) on examination
Measured: 1 year
Secondary outcomes (5)
Quality of Life Questionnaire UDI-6
Response to validated questionnaire: Urinary Distress Index(UDI-6) Measures symptoms on three subscales: 1. Irritative 2. Stress 3. Obstructive/Discomfort. The mean value of all questions answered is then multiplied by 25 for the actual score (range 0 to 100) Summary score - Add the scores from the 3 scales together to obtain the summary score (range 0 to 300) The higher the score the greater the perceived impact that pelvic floor dysfunction has on a patient's life.
Measured: 1 year
Subjective Patient Reported Recurrent or Persistent Stress Urinary Incontinence
Assess if the patient has any complaint of stress urinary incontinence after surgery in follow up visits. This will be history only, no examination.
Measured: 1 year
Number of Participants Who Completed Self- Assessment of Cure
Self-assessment of cure is based on 5 point scale, cured, greatly improved, somewhat improved, not improved, and worsened. This is calculated by the number of patients that were analyzed.
Measured: 1 year
Quality of Life Questionnaire IIQ-7
Response to validated questionnaire: Incontinence Impact Questionnaire(IIQ-7) The IIQ measures the impact of urinary incontinence on activities roles, and emotional states. A mean score is derived from each domain, then transferred to give weight to each subscale. Subscale scores range from 0-100. The total IIQ score is calculated by adding the four subscales score with a range of 0-400 possible. A score closer to 0 represents activities not affected at all versus closer to 400 represent activities that were greatly affected.
Measured: 1 year
Quality of Life Questionnaire ICIQ
Response to validated questionnaire: International Consultation on Incontinence Questionnaire(ICIQ). The ICIQ is a screening tool for incontinence. The scoring scale is 0-21, minimum 0, maximum 21. a higher score indicates greater impairment from incontinence.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study startNov 2008
- Primary completionJan 2011
- Study completionJan 2011
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 Urinary Incontinence, StressStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cecilia Calvo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cecilia Calvo, The Cleveland Clinic
- Investigators
- G Willy Davila, MD, Principal investigator, Cleveland Clinic Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599051
- Sponsor's protocol ID
- IRB 9034
- Status last verified
- Jun 2023
- First submitted
- 3 Nov 2015
- Last updated
- 20 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.
PubMed 37888839
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transobturator Versus Single Incision Slings: 1 Year Results of a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02599051
- Acronym / sponsor ID
- IRB 9034
- Conditions
- Urinary Incontinence, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Cecilia CalvoUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 6 Nov 2015 (estimated)
- Results
- Posted 20 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized control trial to compare the efficacy of the single incision mini-sling to the transobturator sling
Detailed description
Transobturator slings are one type of sling that has become standard treatment for stress urinary incontinence. However, this procedure involves a total of 3 incisions to perform.
In contrast, single incision slings have been developed to treat stress urinary incontinence by using only one incision.
However, to date the success and complications of these two procedures have not been compared or studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monarc | Active comparator | Device: MonarcPlacement of a transobturator monarc sling for stress urinary incontinence |
| Mini-arc | Experimental | Device: Mini-arcPlacement of a single incision mini-arc sling for stress urinary incontinence |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with urodynamically proven stress urinary incontinence who were planning on undergoing surgery for treatment.
Key exclusion criteria (1 listed)
- Patients with prior incontinence surgery, a urodynamic diagnosis of intrinsic sphincter deficiency and mixed incontinence with a predominance of detrusor overactivity were excluded.
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 |
|---|---|---|
| Mini-arcAlso: single incision slingWe will place a single incision sling at the time of surgery for stress urinary incontinence | Device | Mini-arc |
| MonarcAlso: transobturator slingWe will place a transobturator sling at the time of surgery for stress urinary incontinence | Device | Monarc |
Primary outcome
Objective Stress Urinary Incontinence
Time frame: 1 year
The primary outcome was presence of leakage during cough stress test(CST) on examination
5 secondary outcomes
Quality of Life Questionnaire UDI-6
Time frame: 1 year
Subjective Patient Reported Recurrent or Persistent Stress Urinary Incontinence
Time frame: 1 year
Number of Participants Who Completed Self- Assessment of Cure
Time frame: 1 year
Quality of Life Questionnaire IIQ-7
Time frame: 1 year
Quality of Life Questionnaire ICIQ
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37888839Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.
- 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.
G Willy Davila, MD principal investigator
Cleveland Clinic Florida
Questions about this trial
What is this clinical trial studying?
A study testing Mini-arc and Monarc in people with Urinary Incontinence, Stress, run by Cecilia Calvo.
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 1 inclusion and 1 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 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 20 Jul 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?
Objective Stress Urinary Incontinence (time frame: 1 year). 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 NCT02599051, 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 20 Jul 2023.