Stress Urinary IncontinencePhase 2NCT03300973
Urodynamic Study and Stress Incontinence
A Phase 2 study testing sling surgery in people with Stress Urinary Incontinence, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
A trial to answer the debatabal question about the role of urodynamic study in surgical treatment for stress urinary incontinence. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- sling surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2016to Oct 2017
- Phase
- Phase 2
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- stress urinary incontinence
Who cannot join
- mixed incontinence
- recurrent cases
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr El Ainiy Hospital
Cairo, 11562
sarah M Hassan, Lecturer, 01003733671, saramohamed7880@yahoo.com
About this study
Official title: Role of Urodynamic Study Before Surgery for Stress Urinary Incontinence.
A trial to answer the debatabal question about the role of urodynamic study in surgical treatment for stress urinary incontinence.
Read the detailed description
group of patients complaining of stress urinary incontinence and candidate for sling surgery were randomaly divided into 2 groups either to have urodynamic study before surgery or not.
- Conditions
- Stress Urinary Incontinence
- Being tested
- sling surgery
- Keywords
- urodynamic study, stress urinary incontinence
- 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.
sling surgeryProcedure or surgery
transoburator vaginal tape ,inside out procedure under spinal anathesia
| Study group | Role | What they receive |
|---|---|---|
| urodynamics study group | Active comparator | 65 patients with stress urinary incontinence were randomly chosen to have urodynamic study before surgery Receives: Procedure: sling surgery |
| surgery only group | Active comparator | 60 patients with stress urinary incontinence were randomly chosen to have surgery without urodynamics study Receives: Procedure: sling surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
cure of stress incontinence
by clinical assessment
Measured: 1 week after surgery
Secondary outcomes (2)
cure of stress incontinence
by clinical assessment
Measured: one month after surgery
cure of stress incontinence
by clinical assessment
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 posted4 Oct 2017
- Study start15 Jan 2016
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sarah mohamed hassan, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300973
- Sponsor's protocol ID
- 11279
- Status last verified
- Sep 2017
- First submitted
- 21 Sep 2017
- Last updated
- 4 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Urodynamic Study Before Surgery for Stress Urinary Incontinence.
- ClinicalTrials.gov ID
- NCT03300973
- Acronym / sponsor ID
- 11279
- Conditions
- Stress Urinary Incontinence
- Keywords
- urodynamic study, stress urinary incontinence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 15 Jan 2016 (actual)
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 4 Oct 2017 (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.
A trial to answer the debatabal question about the role of urodynamic study in surgical treatment for stress urinary incontinence.
Detailed description
group of patients complaining of stress urinary incontinence and candidate for sling surgery were randomaly divided into 2 groups either to have urodynamic study before surgery or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| urodynamics study group | Active comparator | Procedure: sling surgery65 patients with stress urinary incontinence were randomly chosen to have urodynamic study before surgery |
| surgery only group | Active comparator | Procedure: sling surgery60 patients with stress urinary incontinence were randomly chosen to have surgery without urodynamics study |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- stress urinary incontinence
Key exclusion criteria (2 listed)
- mixed incontinence
- recurrent cases
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 |
|---|---|---|
| sling surgerytransoburator vaginal tape ,inside out procedure under spinal anathesia | Procedure or surgery | surgery only group, urodynamics study group |
Primary outcome
cure of stress incontinence
Time frame: 1 week after surgery
by clinical assessment
2 secondary outcomes
cure of stress incontinence
Time frame: one month after surgery
cure of stress incontinence
Time frame: 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2017.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sling surgery in people with Stress Urinary Incontinence, run by Kasr El Aini Hospital at 1 site in Egypt.
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 2 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 4 Oct 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 Egypt. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Sarah M Hassan, lecturer (01003733671, saramohamed7880@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cure of stress incontinence (time frame: 1 week 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 4 Oct 2017.