Urinary IncontinenceNCT01246271
Sub Urethral Sling With or With Out Anterior Repair
An observational study of Urinary Incontinence, run by Tabriz University at 1 site in Iran.
Trial summary
There is a concern about choosing adequate surgical options for stress urinary incontinence associated with vaginal prolapsed and still lack of evidence can be observed. In this study we compared primary and secondary outcomes of single or combine surgery for SUI with pelvic organ prolapsed. Read more about this study
- Who is it for?
- Ages 27 to 78 years, women only
- Conditions the study is for
- Urinary Incontinence
- How many people
- 98 participants
- Where
- 1 siteIran
- Study dates
- Feb 2008to Dec 2009
- 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 27 to 78 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: woman with stress urinary incontinence
Who may be able to join
- Patients must be female
- Subjective evidence of stress predominant symptoms on symptom specific questionnaire
- Stress incontinence on urodynamics
- Patients must be capable of filling in the symptom diary
- Prolapse beyond the introitus
Who cannot join
- Patients who are medically unfit to undergo surgical intervention.
- Patients who have undergone previous continence surgery
- Patients with voiding dysfunction
- Patients with recurrent urinary tract infection
- Patients who are not sure that their family is complete
Trial locations and contacts
1 site in 1 country.
About this study
Official title: a Retrospective Cohort Recognize the Out Comes of SUS With or Without Anterior Vaginal Repair
There is a concern about choosing adequate surgical options for stress urinary incontinence associated with vaginal prolapsed and still lack of evidence can be observed. In this study we compared primary and secondary outcomes of single or combine surgery for SUI with pelvic organ prolapsed.
- Conditions
- Urinary Incontinence
- Medical subject headings
- Urinary Incontinence
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 |
|---|---|---|
| Sub urethral sling | Not described | |
| sus with anterior vainal wall repair | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary incontinence cure rate according ICIQ-UIsf
Measured: 3 month after surgery
Secondary outcomes (1)
morbidity and complication
Measured: 3 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startFeb 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Retrospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tabriz University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246271
- Sponsor's protocol ID
- 89-234
- Other IDs
- 8948
- Status last verified
- Jan 2008
- First submitted
- 19 Nov 2010
- Last updated
- 23 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Retrospective Cohort Recognize the Out Comes of SUS With or Without Anterior Vaginal Repair
- ClinicalTrials.gov ID
- NCT01246271
- Acronym / sponsor ID
- 89-234
- Conditions
- Urinary Incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Tabriz UniversityUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 23 Nov 2010 (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.
There is a concern about choosing adequate surgical options for stress urinary incontinence associated with vaginal prolapsed and still lack of evidence can be observed. In this study we compared primary and secondary outcomes of single or combine surgery for SUI with pelvic organ prolapsed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sub urethral sling | – | – |
| sus with anterior vainal wall repair | – | – |
Who may qualify
- Ages
- 27 to 78 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- woman with stress urinary incontinence
Key inclusion criteria (5 listed)
- Patients must be female
- Subjective evidence of stress predominant symptoms on symptom specific questionnaire
- Stress incontinence on urodynamics
- Patients must be capable of filling in the symptom diary
- Prolapse beyond the introitus
Key exclusion criteria (5 listed)
- Patients who are medically unfit to undergo surgical intervention.
- Patients who have undergone previous continence surgery
- Patients with voiding dysfunction
- Patients with recurrent urinary tract infection
- Patients who are not sure that their family is complete
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
Urinary incontinence cure rate according ICIQ-UIsf
Time frame: 3 month after surgery
1 secondary outcome
morbidity and complication
Time frame: 3 month after surgery
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 23 Nov 2010.
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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 Urinary Incontinence, run by Tabriz University at 1 site in Iran.
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 5 inclusion and 5 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 23 Nov 2010. 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 Iran. 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?
Urinary incontinence cure rate according ICIQ-UIsf (time frame: 3 month after surgery). 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 23 Nov 2010.