Stress Urinary Incontinence (SUI)NCT07550426
The Effect of Periurethral Injection of Platelet Rich Plasma Versus Mid-urethral Sling in Treatment of Stress Urinary Incontinence
A study testing Platelet Rich Plasma and Mid urethral sling ( trans obturator tape) in people with Stress Urinary Incontinence (SUI), run by Ain Shams University at 1 site in Egypt.
Trial summary
this study used to compare efficacy between platelet rich plasma periurethral injection versus mid urethral sling ( trans obturator tape ) in treatment of stress urinary incontinence Read more about this study
- Who is it for?
- Ages 26 to 66 years, women only
- Conditions the study is for
- Stress Urinary Incontinence (SUI)
- What is being tested?
- Platelet Rich Plasma and Mid urethral sling ( trans obturator tape)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 26 to 66 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stress urinary incontinence identified by urodynamic study
- patient agreement to undergo surgical treatment
Who cannot join
- previous GUS operation
- evidence of detrusor overactivity urinary system
- presence of pelvic organ prolapse
- malignancies of genitourinary system
- history of hemorrhagic disorders , on anti platelet treatment , uncontrolled diabetes mellitus .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Periurethral Injection of Platelet Rich Plasma Versus Mid-urethral Sling in Treatment of Stress Urinary Incontinence : a Randomized Clinical Trial
this study used to compare efficacy between platelet rich plasma periurethral injection versus mid urethral sling ( trans obturator tape ) in treatment of stress urinary incontinence
Read the detailed description
stress urinary incontinence classified in urodynamic study according to Valsalva leak point pressure to intrinsic sphincteric muscle weakness best treated by PRP periurethral injection and VLPP is less than or equal 60cmH2O and MUCP less than 20cmH2O(21 ) patients enrolled in this group , while hypermobile urethra identified by VLPP is high more than 90cmh2O best treated by trans obturator tape(21) patients recruited in this group , mode of preparation of PRP is by withdrawing 15 ml blood and placed in falcon tube with ACD ( acid citrate dextrose) added centrifuged first at 800 RPM and then the supernatant removed and re-centrifuged again at 3500 RPM and then injected periurethral by 5cc syringe with 30G needle after applying 2% lidocaine ,patient assessed at one and three month objectively by cough stress test and subjectively by ICIQ questionnaire and presence of any adverse effect
- Conditions
- Stress Urinary Incontinence (SUI)
- Being tested
- Platelet Rich Plasma, Mid urethral sling ( trans obturator tape)
- 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.
Platelet Rich PlasmaProcedure or surgery
GROUP 1 : 21patient will have platelet rich plasma injected periurethral in intrinsic muscle weakness in stress urinary incontinence
Mid urethral sling ( trans obturator tape)Procedure or surgery
GROUP 2 : (21) patient having SUI due to hypermobile urethra will have TOT
| Study group | Role | What they receive |
|---|---|---|
| patients complaining of stress urinary incontinence based on urodynamic study | Experimental | GROUP 1: 21 patients allocated who have SUI ISD will receive PRP GROUP 2: 21 patient who have hypermobile urethra will receive TOT Receives: Procedure: Platelet Rich Plasma; Procedure: Mid urethral sling ( trans obturator tape) |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective assessment of urinary leakage through cough stress test
Measured: after one and three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start15 Apr 2026
- Primary completion15 Apr 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary Incontinence (SUI)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- randomized controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- mohamed A N, MD, Study director, urogynecology unit ainshams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550426
- Sponsor's protocol ID
- FMASU MD285/2025
- Status last verified
- Jul 2026
- First submitted
- 18 Apr 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: in informed consent all participants information will be only known by the research and investigator committee and their personal information will be kept with confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Periurethral Injection of Platelet Rich Plasma Versus Mid-urethral Sling in Treatment of Stress Urinary Incontinence : a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07550426
- Acronym / sponsor ID
- FMASU MD285/2025
- Conditions
- Stress Urinary Incontinence (SUI)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 24 Apr 2026 (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 study used to compare efficacy between platelet rich plasma periurethral injection versus mid urethral sling ( trans obturator tape ) in treatment of stress urinary incontinence
Detailed description
stress urinary incontinence classified in urodynamic study according to Valsalva leak point pressure to intrinsic sphincteric muscle weakness best treated by PRP periurethral injection and VLPP is less than or equal 60cmH2O and MUCP less than 20cmH2O(21 ) patients enrolled in this group , while hypermobile urethra identified by VLPP is high more than 90cmh2O best treated by trans obturator tape(21) patients recruited in this group , mode of preparation of PRP is by withdrawing 15 ml blood and placed in falcon tube with ACD ( acid citrate dextrose) added centrifuged first at 800 RPM and then the supernatant removed and re-centrifuged again at 3500 RPM and then injected periurethral by 5cc syringe with 30G needle after applying 2% lidocaine ,patient assessed at one and three month objectively by cough stress test and subjectively by ICIQ questionnaire and presence of any adverse effect
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| patients complaining of stress urinary incontinence based on urodynamic study | Experimental | Procedure: Platelet Rich Plasma, Procedure: Mid urethral sling ( trans obturator tape)GROUP 1: 21 patients allocated who have SUI ISD will receive PRP GROUP 2: 21 patient who have hypermobile urethra will receive TOT |
Who may qualify
- Ages
- 26 to 66 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- stress urinary incontinence identified by urodynamic study
- patient agreement to undergo surgical treatment
Key exclusion criteria (5 listed)
- previous GUS operation
- evidence of detrusor overactivity urinary system
- presence of pelvic organ prolapse
- malignancies of genitourinary system
- history of hemorrhagic disorders , on anti platelet treatment , uncontrolled diabetes mellitus .
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 |
|---|---|---|
| Platelet Rich PlasmaGROUP 1 : 21patient will have platelet rich plasma injected periurethral in intrinsic muscle weakness in stress urinary incontinence | Procedure or surgery | patients complaining of stress urinary incontinence based on urodynamic study |
| Mid urethral sling ( trans obturator tape)GROUP 2 : (21) patient having SUI due to hypermobile urethra will have TOT | Procedure or surgery | patients complaining of stress urinary incontinence based on urodynamic study |
Primary outcome
objective assessment of urinary leakage through cough stress test
Time frame: after one and three months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No. in informed consent all participants information will be only known by the research and investigator committee and their personal information will be kept with confidentiality
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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.
mohamed A N, MD study director
urogynecology unit ainshams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet Rich Plasma and Mid urethral sling ( trans obturator tape) in people with Stress Urinary Incontinence (SUI), 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 2 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: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 assessment of urinary leakage through cough stress test (time frame: after one and three months). 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 22 Jul 2026.