Urinary Incontinence,StressNCT03620604
Mid Term Safety and Efficacy of ALTIS® Single Incision Sling for Female Stress Urinary Incontinence (SUI).
An observational study of Urinary Incontinence,Stress, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
Trial summary
Prospective, single-arm, non-sponsored, observational single centre trial in a cohort of patients undergoing stress urinary incontinence surgery with ALTIS® procedure. All patients were diagnosed according to clinical reports, physical exploration and urodynamics. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Urinary Incontinence,Stress
- What is being tested?
- Stress urinary incontinence surgery
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2014to 31 Dec 2020
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients were selected from our National Health System both forwarded from primary care or f from gynecology or other urologist to de Urodynamic Unit
Who may be able to join
- Urodynamically proven stress urinary incontinence
- Refractory to 6 months of non-surgical therapies including behavioural changes or drug therapy
Who cannot join
- Pelvic infection
- Pelvic organ prolapse ≥Stage 2
- Prior stress urinary incontinence surgery
- Neurogenic bladder incontinence,
- Previous pelvic radiotherapy,
- High post-voiding volume (100 mL in two times)
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mid Term Safety and Efficacy of ALTIS® Single Incision Sling for Female SUI. Less Mesh, Same Results.
Prospective, single-arm, non-sponsored, observational single centre trial in a cohort of patients undergoing stress urinary incontinence surgery with ALTIS® procedure. All patients were diagnosed according to clinical reports, physical exploration and urodynamics. Body mass index(BMI) was categorized according to World Health Organization classification. Valsalva leak point pressure was categorized in three groups <60 cmH2O, 60-90 cmH2O and >90 cmH2O). Participants were evaluated post-operatively at 1, 6, 12 and 24 months with physical examination, ICIQ-SF, visual scale of satisfaction(SVS)(0-10). Adverse events were reported in each visit. Multivariate analysis for risk factors of surgery failure was performed.
Read the detailed description
This is a prospective, single -arm, non-sponsored observational single centre trial in a cohort of patients undergoing stress urinary incontinence surgery with ALTIS® procedure. Two urologists, experts in female incontinence surgery, performed all procedures. Safety and efficacy were evaluated. All participants provided written informed consent prior to enrolment.
The investigators recruited female patients aged 35 years or more with urodynamically proven stress urinary incontinence and who had failed to 6 months of non-surgical therapies including behavioural changes and drug therapy. Exclusion criteria were pelvic infection, pelvic organ prolapse ≥Stage 2, prior stress urinary incontinence surgery, neurogenic bladder incontinence, previous pelvic radiotherapy, high post-voiding volume (100 mL in two times) or being pregnant.
Demographic variables (age, number of vaginal deliveries, prior stress urinary incontinence surgery, menopause status, BMI and presence of urge incontinence) were collected. BMI was categorized according to World Health Organization in normal (18,5-24,9 Kg/m2), overweight (25-29,9 Kg/m2) and obese (≥ 30 Kg/m2) patients. For statistical purpose the investigators divided patients into two groups, non-obese (18,5-29,9) Kg/m2) and obese (≥ 30 Kg/m2) patients.
Preoperative assessment included urogynecological history, cough test (stress test with at least 300 mL of bladder volume measured by ultrasound), Spanish validated version of the International Consultation on Incontinence Questionnaire sort form (ICIQ-SF) and urodynamic test (Urodynamic parameters as Valsalva leak point pressure (VLPP), non-inhibited detrusor contractions and post-voiding volume were reflected. VLPP was categorized into three groups <60 cmH2O, 60-90 cmH2O and >90 cmH2O).
Follow up was carried out with physical examination, ICIQ-SF, visual scale of satisfaction and physical examination including cough test. Subjects were evaluated post-operatively at 1, 6, 12 and 24 months. Adverse events, such as vaginal erosion or pain related to the procedure or the device were evaluated at each visit.
The primary efficacy measures were objective cure, defined as negative cough test, and subjective cure, defined as ICIQ-SF=0.
- Conditions
- Urinary Incontinence,Stress
- Being tested
- Stress urinary incontinence surgery
- Keywords
- single incision sling, safety, efficacy
- 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.
Stress urinary incontinence surgeryDevice
Also called ALTIS device
All patients were treated according to the Urology protocols of our unit. They were patients with stress urinary incontinence refractory to pelvic floor exercises so they underwent surgery
| Study group | Role | What they receive |
|---|---|---|
| Stress urinary incontinence surgery | This is a single observational study were all patients had stress urinary incontinence. All of them underwent surgery performing a single incision sling type ALTIS Receives: Device: Stress urinary incontinence surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mid term Efficacy/continence
Mid term Efficacy and continence measured with cough test ( Positive or negative)
Measured: Assessed at 24 months of follow up
Secondary outcomes (3)
Voiding disfunction
Difficulty to void assessed by uroflowmetry (mL/s)
Measured: Assessed every visit at 1,6,12,24 months
De novo urgency
measured by International Consultation on Incontinence Questionnaire Sort Form (ICIQ-SF) ( from 0 to 21 being 0 = to continence and 21= the worse outcome of incontinence)
Measured: Assessed at visit 6,12,24 months
Safety and adverse events
Safety was assessed by physical examination to rule out vaginal extrusion (yes/no)
Measured: Assessed every visit at 1,6,12,24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start1 Jan 2014
- Primary completion27 Feb 2018
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Instituto de Investigacion Sanitaria La Fe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduardo Moran, Instituto de Investigacion Sanitaria La Fe
- Investigators
- Eduardo J Moran Pascual, Doctor, Principal investigator, Hospital Universitario La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620604
- Sponsor's protocol ID
- ALTIS STUDY
- Status last verified
- Aug 2018
- First submitted
- 28 Jul 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is a single centre study we don't think it will be useful to make these data available to other researchers
Publications
Kocjancic E, Erickson T, Tu LM, Gheiler E, Van Drie D. Two-year outcomes for the Altis(R) adjustable single incision sling system for treatment of stress urinary incontinence. Neurourol Urodyn. 2017 Aug;36(6):1582-1587. doi: 10.1002/nau.23156. Epub 2016 Oct 29.
PubMed 27794177Van Drie DM. The Impact of Procedure Setting on Two-Year Outcomes for the Altis Single Incision Sling for Women With Stress Urinary Incontinence. J Minim Invasive Gynecol. 2015 Nov-Dec;22(6S):S243-S244. doi: 10.1016/j.jmig.2015.08.853. Epub 2015 Oct 15. No abstract available.
PubMed 27679164Dias J, Xambre L, Costa L, Costa P, Ferraz L. Short-term outcomes of Altis single-incision sling procedure for stress urinary incontinence: a prospective single-center study. Int Urogynecol J. 2014 Aug;25(8):1089-95. doi: 10.1007/s00192-014-2355-4. Epub 2014 Mar 6.
PubMed 24599178
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mid Term Safety and Efficacy of ALTIS® Single Incision Sling for Female SUI. Less Mesh, Same Results.
- ClinicalTrials.gov ID
- NCT03620604
- Acronym / sponsor ID
- ALTIS STUDY
- Conditions
- Urinary Incontinence,Stress
- Keywords
- single incision sling, safety, efficacy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Instituto de Investigacion Sanitaria La FeUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 27 Feb 2018 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 8 Aug 2018 (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.
Prospective, single-arm, non-sponsored, observational single centre trial in a cohort of patients undergoing stress urinary incontinence surgery with ALTIS® procedure. All patients were diagnosed according to clinical reports, physical exploration and urodynamics. Body mass index(BMI) was categorized according to World Health Organization classification. Valsalva leak point pressure was categorized in three groups <60 cmH2O, 60-90 cmH2O and >90 cmH2O). Participants were evaluated post-operatively at 1, 6, 12 and 24 months with physical examination, ICIQ-SF, visual scale of satisfaction(SVS)(0-10). Adverse events were reported in each visit. Multivariate analysis for risk factors of surgery failure was performed.
Detailed description
This is a prospective, single -arm, non-sponsored observational single centre trial in a cohort of patients undergoing stress urinary incontinence surgery with ALTIS® procedure. Two urologists, experts in female incontinence surgery, performed all procedures. Safety and efficacy were evaluated. All participants provided written informed consent prior to enrolment.
The investigators recruited female patients aged 35 years or more with urodynamically proven stress urinary incontinence and who had failed to 6 months of non-surgical therapies including behavioural changes and drug therapy. Exclusion criteria were pelvic infection, pelvic organ prolapse ≥Stage 2, prior stress urinary incontinence surgery, neurogenic bladder incontinence, previous pelvic radiotherapy, high post-voiding volume (100 mL in two times) or being pregnant.
Demographic variables (age, number of vaginal deliveries, prior stress urinary incontinence surgery, menopause status, BMI and presence of urge incontinence) were collected. BMI was categorized according to World Health Organization in normal (18,5-24,9 Kg/m2), overweight (25-29,9 Kg/m2) and obese (≥ 30 Kg/m2) patients. For statistical purpose the investigators divided patients into two groups, non-obese (18,5-29,9) Kg/m2) and obese (≥ 30 Kg/m2) patients.
Preoperative assessment included urogynecological history, cough test (stress test with at least 300 mL of bladder volume measured by ultrasound), Spanish validated version of the International Consultation on Incontinence Questionnaire sort form (ICIQ-SF) and urodynamic test (Urodynamic parameters as Valsalva leak point pressure (VLPP), non-inhibited detrusor contractions and post-voiding volume were reflected. VLPP was categorized into three groups <60 cmH2O, 60-90 cmH2O and >90 cmH2O).
Follow up was carried out with physical examination, ICIQ-SF, visual scale of satisfaction and physical examination including cough test. Subjects were evaluated post-operatively at 1, 6, 12 and 24 months. Adverse events, such as vaginal erosion or pain related to the procedure or the device were evaluated at each visit.
The primary efficacy measures were objective cure, defined as negative cough test, and subjective cure, defined as ICIQ-SF=0.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stress urinary incontinence surgery | – | Device: Stress urinary incontinence surgeryThis is a single observational study were all patients had stress urinary incontinence. All of them underwent surgery performing a single incision sling type ALTIS |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were selected from our National Health System both forwarded from primary care or f from gynecology or other urologist to de Urodynamic Unit
Key inclusion criteria (2 listed)
- Urodynamically proven stress urinary incontinence
- Refractory to 6 months of non-surgical therapies including behavioural changes or drug therapy
Key exclusion criteria (7 listed)
- Pelvic infection
- Pelvic organ prolapse ≥Stage 2
- Prior stress urinary incontinence surgery
- Neurogenic bladder incontinence,
- Previous pelvic radiotherapy,
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 |
|---|---|---|
| Stress urinary incontinence surgeryAlso: ALTIS deviceAll patients were treated according to the Urology protocols of our unit. They were patients with stress urinary incontinence refractory to pelvic floor exercises so they underwent surgery | Device | Stress urinary incontinence surgery |
Primary outcome
Mid term Efficacy/continence
Time frame: Assessed at 24 months of follow up
Mid term Efficacy and continence measured with cough test ( Positive or negative)
3 secondary outcomes
Voiding disfunction
Time frame: Assessed every visit at 1,6,12,24 months
De novo urgency
Time frame: Assessed at visit 6,12,24 months
Safety and adverse events
Time frame: Assessed every visit at 1,6,12,24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Background: PubMed 27794177Kocjancic E, Erickson T, Tu LM, Gheiler E, Van Drie D. Two-year outcomes for the Altis(R) adjustable single incision sling system for treatment of stress urinary incontinence. Neurourol Urodyn. 2017 Aug;36(6):1582-1587. doi: 10.1002/nau.23156. Epub 2016 Oct 29.
- Background: PubMed 27679164Van Drie DM. The Impact of Procedure Setting on Two-Year Outcomes for the Altis Single Incision Sling for Women With Stress Urinary Incontinence. J Minim Invasive Gynecol. 2015 Nov-Dec;22(6S):S243-S244. doi: 10.1016/j.jmig.2015.08.853. Epub 2015 Oct 15. No abstract available.
- Background: PubMed 24599178Dias J, Xambre L, Costa L, Costa P, Ferraz L. Short-term outcomes of Altis single-incision sling procedure for stress urinary incontinence: a prospective single-center study. Int Urogynecol J. 2014 Aug;25(8):1089-95. doi: 10.1007/s00192-014-2355-4. Epub 2014 Mar 6.
- Individual participant dataSharing planned: No. This is a single centre study we don't think it will be useful to make these data available to other researchers
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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.
Eduardo J Moran Pascual, Doctor principal investigator
Hospital Universitario La Fe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence,Stress, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
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 2 inclusion and 7 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 9 Aug 2018. 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 Spain. 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?
Mid term Efficacy/continence (time frame: Assessed at 24 months of follow up). 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 NCT03620604, which also lists 3 linked publications.
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 9 Aug 2018.