Stress Urinary IncontinenceNCT01657916
5-Year Objective and Subjective Results of a Mid-Urethral Sling
An observational study of Stress Urinary Incontinence, run by Atlantic Health System at 1 site in United States.
Trial summary
Evaluate 5-year objective and subjective cure rates after implant of the retropubic Align Urethral Support System. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jul 2015
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women who suffered from stress urinary incontinence (leakage of urine will laughing/coughing/sneezing/exercising)
Who may be able to join
- women
- complaint of stress urinary incontinence
- underwent Align urethral support system from June 2007-December 2008
Who cannot join
- concommitant procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlantic Health System
Morristown, New Jersey, 07960
About this study
Evaluate 5-year objective and subjective cure rates after implant of the retropubic Align Urethral Support System.
Read the detailed description
Between June 2007 and December 2008, the investigators performed 155 Align mid-urethral slings in patients who were only receiving this operation. Very few studies have outcomes at 5 years of greater. The aim of this prospective cohort study is to evaluate five-year objective and subjective cure rates. Secondary endpoints will assess failure risk factors and describe any complications of the retropublic Align Urethral Support System five years postoperatively.
- Conditions
- Stress Urinary Incontinence
- Keywords
- mid-urethral sling, Align urethral support system, tension free vaginal tape, cough stress test, pelvic exam, PFDI-20, PFIQ, SSQ, Urinary retention, mesh erosion, urodynamics
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 5 year sling implants | Patients who underwent implant of the Align Urethral Support System between June 2007 and December 2008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough stress test
Patient will void and their post-void residual amount of urine will be obtained by a catheter. That same catheter will be left in place and used to fill the bladder with 250ml sterile saline. The patient will then be asked to vigorously cough in the upright sitting and standing positions. A positive "cough test" will be defined as any leakage of urine that is visualized during coughing in the sitting or standing position.
Measured: 5 year follow up appt
Secondary outcomes (4)
Pelvic exam
Standardized pelvic exam will be performed to assess healing, palpability, mesh related pain and erosion of the sling.
Measured: 5 year follow up appt
Stress urinary incontinence related symptoms
Validated stress urinary incontinence related questionnaires were completed prior to surgery by all of these patients, and will be completed 5 years after surgery as well. The specific forms used will be PFDI-20 and incontinence severity index. Question 17 of the pelvic floor distress inventory will be used to assess subjective cure.
Measured: 5 year follow up appointment
Urgency incontinence related symptoms
Patients will be assessed for de novo, stable and improved urgency incontinence using the IIQ-7 subject of PFDI-20 (questions 15, 16, and 18).
Measured: 5 year follow up appointment
Quality of life and self-reported data
Validated questionnaires (Incontinence outcome questionnaire, surgical satisfaction questionaire) will be used to assess patient's surgery satisfaction, subjective self-assessment before and 5 years after the surgery.
Measured: 5 year follow up appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2015
- Study completionJul 2015
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657916
- Sponsor's protocol ID
- R12-01-005
- Status last verified
- Jun 2017
- First submitted
- 2 Aug 2012
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5-Year Objective and Subjective Results of a Mid-Urethral Sling
- ClinicalTrials.gov ID
- NCT01657916
- Acronym / sponsor ID
- R12-01-005
- Conditions
- Stress Urinary Incontinence
- Keywords
- mid-urethral sling, Align urethral support system, tension free vaginal tape, cough stress test, pelvic exam, PFDI-20, PFIQ, SSQ
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 6 Aug 2012 (estimated)
- 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.
Evaluate 5-year objective and subjective cure rates after implant of the retropubic Align Urethral Support System.
Detailed description
Between June 2007 and December 2008, the investigators performed 155 Align mid-urethral slings in patients who were only receiving this operation. Very few studies have outcomes at 5 years of greater. The aim of this prospective cohort study is to evaluate five-year objective and subjective cure rates. Secondary endpoints will assess failure risk factors and describe any complications of the retropublic Align Urethral Support System five years postoperatively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 5 year sling implants | – | –Patients who underwent implant of the Align Urethral Support System between June 2007 and December 2008 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women who suffered from stress urinary incontinence (leakage of urine will laughing/coughing/sneezing/exercising)
Key inclusion criteria (3 listed)
- women
- complaint of stress urinary incontinence
- underwent Align urethral support system from June 2007-December 2008
Key exclusion criteria (1 listed)
- concommitant procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cough stress test
Time frame: 5 year follow up appt
Patient will void and their post-void residual amount of urine will be obtained by a catheter. That same catheter will be left in place and used to fill the bladder with 250ml sterile saline. The patient will then be asked to vigorously cough in the upright sitting and standing positions. A positive "cough test" will be defined as any leakage of urine that is visualized during coughing in the sitting or standing position.
4 secondary outcomes
Pelvic exam
Time frame: 5 year follow up appt
Stress urinary incontinence related symptoms
Time frame: 5 year follow up appointment
Urgency incontinence related symptoms
Time frame: 5 year follow up appointment
Quality of life and self-reported data
Time frame: 5 year follow up appointment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Stress Urinary Incontinence, run by Atlantic Health System 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 3 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 9 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cough stress test (time frame: 5 year follow up appt). 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 9 Jun 2017.