Urinary Stress IncontinenceNCT04101279
Midurethral Synthetic Tape With Tension Control Mechanism Versus Midurethral Free Tape
A study testing surgical management of stress urinary incontinence with midurethral tension free tape. in people with Urinary Stress Incontinence, run by Moscow State University of Medicine and Dentistry at 1 site in Russia.
Trial summary
This is a prospective, comparative randomized controled trial. The general purposes of this study is to compare the efficacy and safety of midurethral synthetic tape with tension control mechanism and conventional midurethral tension free tape as surgical treatment for female urinary stress incontinence. Read more about this study
- Who is it for?
- Ages 21 to 80 years, women only
- Conditions the study is for
- Urinary Stress Incontinence
- What is being tested?
- surgical management of stress urinary incontinence with midurethral tension free tape.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- 1 Apr 2018to Dec 2019
- Phase
- Interventional
- 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 21 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women suffering from stress urinary incontinence, mixed urinary incontinence with prevalence stress urinary incontinence
Who cannot join
- Pregnancy
- Women with neurogenic bladder dysfunction
- Recurrent stress urinary incontinence
- Woman with history of pelvic surgery
- Mixed urinary incontinence with prevalence urgency urinary incontinence
- Women who suffer from advanced POP (POP-Quantification system (POP-Q) stage more than 2)
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- Women with acute urinary tract infection
- Women with bladder outlet obstruction
- Women who are not able to give informed consent or participate with this randomized research study for any other reason
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Moscow state university of medicine and dentistry named after A.I. Evdokimov
Moscow, 127473
George Kasyan, +7(915)464-33-18, urodep@msmsu.ru
George Kasyan
About this study
Official title: Evaluation of the Effectiveness and Safety of the Midurethral Synthetic Tape With Tension Control Mechanism and Midurethral Tension Free Tape
This is a prospective, comparative randomized controled trial. The general purposes of this study is to compare the efficacy and safety of midurethral synthetic tape with tension control mechanism and conventional midurethral tension free tape as surgical treatment for female urinary stress incontinence.
- Conditions
- Urinary Stress Incontinence
- Being tested
- surgical management of stress urinary incontinence with midurethral tension free tape., surgical management of stress urinary incontinence with synthetic tape with tension control mechanism.
- Keywords
- stress urinary incontinence, midurethral tension free tape, patient reported outcome, bladder outlet obstruction, complications, tension control mechanism
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Bladder Neck Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical management of stress urinary incontinence with midurethral tension free tape.Procedure or surgery
Standard protocol for the surgical treatment of stress urinary incontinence using a transobturator approach.
surgical management of stress urinary incontinence with synthetic tape with tension control mechanism.Procedure or surgery
Standard protocol for the surgical treatment of stress urinary incontinence using a transobturator approach. A absorbing gasket attached to the middle of the tape provides tension control.
| Study group | Role | What they receive |
|---|---|---|
| Midurethral synthetic tape with tension control mechanism | Experimental | Not described Receives: Procedure: surgical management of stress urinary incontinence with synthetic tape with tension control mechanism. |
| midurethral tension free tape | Active comparator | Not described Receives: Procedure: surgical management of stress urinary incontinence with midurethral tension free tape. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported outcome measured as urogenital distress inventory (UDI-6) will be assessed before and after surgery at 12 weeks and 1 year.
The UDI measures the impact of urinary incontinence on activities, roles, and emotional states in women. This questionnaire presented six questions related to urinary disorders. The patient could answer "Not at all", "A little bit", "Moderately" or "Greatly", to each of the questions, each answer is evaluated at 0, 1, 2 or 3 points, respectively, and then summed up. The final score means that the greater the sum of the indicators, the worse the patient's condition.
This score reflects the condition of the patient before and after surgery at 12 weeks and 1 year.
Measured: 1 year
Secondary outcomes (2)
Bladder outlet obstruction measured during urodynamics pressure flow study
When the urodynamic research indicators deviate (Qmax < 12 ml/s and Postvoid residual volume (PVR) > 100 ml, we establish a diagnosis bladder outlet obstruction.
Measured: 1 year
Stress cough test measured before and after surgery.
Objective cure rate will be not the leakage at physical examination cough test with full bladder (200-400ml)
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 posted24 Sep 2019
- Study start1 Apr 2018
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Stress 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled comparative study
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moscow State University of Medicine and Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gevorg Kasyan, Moscow State University of Medicine and Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101279
- Sponsor's protocol ID
- MoscowSUMD
- Status last verified
- Sep 2019
- First submitted
- 14 Jun 2019
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness and Safety of the Midurethral Synthetic Tape With Tension Control Mechanism and Midurethral Tension Free Tape
- ClinicalTrials.gov ID
- NCT04101279
- Acronym / sponsor ID
- MoscowSUMD
- Conditions
- Urinary Stress Incontinence
- Keywords
- stress urinary incontinence, midurethral tension free tape, patient reported outcome, bladder outlet obstruction, complications, tension control mechanism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Moscow State University of Medicine and DentistryUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 24 Sep 2019 (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.
This is a prospective, comparative randomized controled trial. The general purposes of this study is to compare the efficacy and safety of midurethral synthetic tape with tension control mechanism and conventional midurethral tension free tape as surgical treatment for female urinary stress incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled comparative study
| Arm | Type | Receives |
|---|---|---|
| Midurethral synthetic tape with tension control mechanism | Experimental | Procedure: surgical management of stress urinary incontinence with synthetic tape with tension control mechanism. |
| midurethral tension free tape | Active comparator | Procedure: surgical management of stress urinary incontinence with midurethral tension free tape. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women suffering from stress urinary incontinence, mixed urinary incontinence with prevalence stress urinary incontinence
Key exclusion criteria (9 listed)
- Pregnancy
- Women with neurogenic bladder dysfunction
- Recurrent stress urinary incontinence
- Woman with history of pelvic surgery
- Mixed urinary incontinence with prevalence urgency urinary incontinence
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 |
|---|---|---|
| surgical management of stress urinary incontinence with midurethral tension free tape.Standard protocol for the surgical treatment of stress urinary incontinence using a transobturator approach. | Procedure or surgery | midurethral tension free tape |
| surgical management of stress urinary incontinence with synthetic tape with tension control mechanism.Standard protocol for the surgical treatment of stress urinary incontinence using a transobturator approach. A absorbing gasket attached to the middle of the tape provides tension control. | Procedure or surgery | Midurethral synthetic tape with tension control mechanism |
Primary outcome
Patient reported outcome measured as urogenital distress inventory (UDI-6) will be assessed before and after surgery at 12 weeks and 1 year.
Time frame: 1 year
The UDI measures the impact of urinary incontinence on activities, roles, and emotional states in women. This questionnaire presented six questions related to urinary disorders. The patient could answer "Not at all", "A little bit", "Moderately" or "Greatly", to each of the questions, each answer is evaluated at 0, 1, 2 or 3 points, respectively, and then summed up. The final score means that the greater the sum of the indicators, the worse the patient's condition. This score reflects the condition of the patient before and after surgery at 12 weeks and 1 year.
2 secondary outcomes
Bladder outlet obstruction measured during urodynamics pressure flow study
Time frame: 1 year
Stress cough test measured before and after surgery.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
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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 study testing surgical management of stress urinary incontinence with midurethral tension free tape. in people with Urinary Stress Incontinence, run by Moscow State University of Medicine and Dentistry at 1 site in Russia.
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 9 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 24 Sep 2019. 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 Russia. 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?
Contact Lyudmila Potapova (+7(915)248-30-20, urodep@msmsu.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported outcome measured as urogenital distress inventory (UDI-6) will be assessed before and after surgery at 12 weeks and 1 year. (time frame: 1 year). 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 24 Sep 2019.