Stress Urinary IncontinencePhase 2/3NCT02263534
Comparing Minisling to Tension Free Vaginal Tape in Mangement of Stress Urinary Incontinence
A Phase 2/3 study testing single incision minisling and tension free vaginal tape in people with Stress Urinary Incontinence, run by Ain Shams University at 1 site in Egypt.
Trial summary
Based on previous studies the single incision minisling is an easy less invasive procedure with fewer complications and cure rate similar to conventional midurethral slings in the treatment of female stress urinary incontinence. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- single incision minisling and tension free vaginal tape
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2014to Oct 2017
- Phase
- Phase 2/3
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with urodynamic stress urinary incontinence, with or without pelvic organ prolapse
Who cannot join
- Patients with overactive bladder on urodynamic study.
- Patients with voiding dysfunction.
- Patients with intrinsic sphincteric deficiency.
- Patients with previous anti-incontinence surgery.
- Patients on anti-coagulant therapy.
- Immune-compromised patients (DM, patients on corticosteroids treatment).
- Refusal of surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Comparing Minisling to Tension Free Vaginal Tape in Mangement of Stress Urinary Incontinence
Based on previous studies the single incision minisling is an easy less invasive procedure with fewer complications and cure rate similar to conventional midurethral slings in the treatment of female stress urinary incontinence. The aim of this study is to test the hypothesis that the single incision mini-sling placed in the "U" position is not inferior to TVT in this patient population.
- Conditions
- Stress Urinary Incontinence
- Being tested
- single incision minisling, tension free vaginal tape
- Keywords
- stress urinary incontinence, tension free vaginal tape, single incision minisling, midurethral sling
- 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.
single incision minislingProcedure or surgery
midline incision of the vagina at midurethral level dissection of the vagina from perivesical fascia insertion of the tape (polypropylene macropore mesh tape) in the retropubic direction with its end grasped with an artery forceps till level of perineal membrane closure of the vagina 2 sham incisions if the skin only will be made at suprapubic to maintain blindness posterior colpoperneorraphy will be carried out if needed
tension free vaginal tapeProcedure or surgery
Also called TVT
midline incision of the vagina at midurethral level dissection of the vagina from perivesical fascia insertion of the tape (polypropylene macropore mesh tape) with the applicators in the retropubic direction and 2 skin incision will be made supra pubic through which the applicators will be passed and removed and the tape will be cut at level just below the skin closure of the vagina posterior colpoperneorraphy will be carried out if needed
| Study group | Role | What they receive |
|---|---|---|
| minisling | Experimental | patients in this arm will undergo single incision minisling Receives: Procedure: single incision minisling |
| tension free vaginal tape | Sham comparator | patients in this arm will undergo tension free vaginal tape Receives: Procedure: tension free vaginal tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective cure rate of urinary incontinence at 12 months after surgery
Objective cure is indicated by a negative stress test and the absence of any additional surgical or nonsurgical treatment for stress urinary incontinence
Measured: 12 months
subjective cure rate of urinary incontinence at 12 months after surgery
subjective cure is indicated by an Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment for stress urinary incontinence
Measured: 12 months
Secondary outcomes (2)
Number of participants with short- term complications
short-term complications (less than 6 weeks): post-operative pain, urinary retention, denovo urgency and wound sepsis
Measured: 12 months
Number of participants with long-term complications
long-term complications: erosion, dyspareunia and recurrence
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study start10 Nov 2014
- Primary completionJun 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Reda, Ain Shams University
- Investigators
- ahmed reda, M.Sc, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263534
- Sponsor's protocol ID
- SIMS001
- Status last verified
- Sep 2018
- First submitted
- 20 Aug 2014
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.
PubMed 37888839
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Minisling to Tension Free Vaginal Tape in Mangement of Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT02263534
- Acronym / sponsor ID
- SIMS001
- Conditions
- Stress Urinary Incontinence
- Keywords
- stress urinary incontinence, tension free vaginal tape, single incision minisling, midurethral sling
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Nov 2014 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 13 Oct 2014 (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.
Based on previous studies the single incision minisling is an easy less invasive procedure with fewer complications and cure rate similar to conventional midurethral slings in the treatment of female stress urinary incontinence. The aim of this study is to test the hypothesis that the single incision mini-sling placed in the "U" position is not inferior to TVT in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| minisling | Experimental | Procedure: single incision minislingpatients in this arm will undergo single incision minisling |
| tension free vaginal tape | Sham comparator | Procedure: tension free vaginal tapepatients in this arm will undergo tension free vaginal tape |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with urodynamic stress urinary incontinence, with or without pelvic organ prolapse
Key exclusion criteria (7 listed)
- Patients with overactive bladder on urodynamic study.
- Patients with voiding dysfunction.
- Patients with intrinsic sphincteric deficiency.
- Patients with previous anti-incontinence surgery.
- Patients on anti-coagulant therapy.
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 |
|---|---|---|
| single incision minislingmidline incision of the vagina at midurethral level dissection of the vagina from perivesical fascia insertion of the tape (polypropylene macropore mesh tape) in the retropubic direction with its end grasped with an artery forceps till level of perineal membrane closure of the vagina 2 sham incisions if the skin only will be made at suprapubic to maintain blindness posterior colpoperneorraphy will be carried out if needed | Procedure or surgery | minisling |
| tension free vaginal tapeAlso: TVTmidline incision of the vagina at midurethral level dissection of the vagina from perivesical fascia insertion of the tape (polypropylene macropore mesh tape) with the applicators in the retropubic direction and 2 skin incision will be made supra pubic through which the applicators will be passed and removed and the tape will be cut at level just below the skin closure of the vagina posterior colpoperneorraphy will be carried out if needed | Procedure or surgery | tension free vaginal tape |
Primary outcome
objective cure rate of urinary incontinence at 12 months after surgery
Time frame: 12 months
Objective cure is indicated by a negative stress test and the absence of any additional surgical or nonsurgical treatment for stress urinary incontinence
subjective cure rate of urinary incontinence at 12 months after surgery
Time frame: 12 months
subjective cure is indicated by an Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment for stress urinary incontinence
2 secondary outcomes
Number of participants with short- term complications
Time frame: 12 months
Number of participants with long-term complications
Time frame: 12 months
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 19 Sep 2018.
- Derived from this study: PubMed 37888839Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.
- Individual participant dataSharing planned: Undecided
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Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
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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.
ahmed reda, M.Sc principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing single incision minisling and tension free vaginal tape in people with Stress Urinary Incontinence, run by Ain Shams University 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 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: finished, as of the sponsor's last update on 19 Sep 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 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
objective cure rate of urinary incontinence at 12 months after surgery (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT02263534, which also lists 1 linked publication.
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 19 Sep 2018.