Female Stress Urinary IncontinencePhase 3NCT07366762
Comparison Between Two Techniques in Treatment of Female Stress Urinary Incontinence
A Phase 3 study testing Platelet Rich Plasma and Platelet rich fibrin in people with Female Stress Urinary Incontinence, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
compare the therapeutic effect of periurethral injection of autologous platelet-rich plasma (PRP) and injectable platelet rich fibrin (i-PRF) in treatment of female stress urinary incontinence and comparing the need for re-injection in the two groups. Read more about this study
- Who is it for?
- Ages 30 to 75 years, women only
- Conditions the study is for
- Female Stress Urinary Incontinence
- What is being tested?
- Platelet Rich Plasma and Platelet rich fibrin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2024to 2 Jan 2026
- Phase
- Phase 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 30 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with primary symptoms of SUI confirmed by patient's medical history and clinical examination, including a focused incontinence evaluation
- Age range of 30-75 years
- Females unfit for surgery
- Females with SUI recurrence after previous surgical procedure by suburethal sling
- Females refusing surgical interventions
Who cannot join
- Residual urine volume exceeding 100 cc after excretion
- Evidence of detrusor over-activity on the urodynamic test
- Active urinary tract or vaginal infection
- Malignancies of the genitourinary system
- Patients with genitourinary fistula or urethral diverticulum
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between the Effect of Periurethral Injection of Platelet-rich Plasma VS Platelet Rich Fibrin in Treatment of Female Stress Urinary Incontinence
compare the therapeutic effect of periurethral injection of autologous platelet-rich plasma (PRP) and injectable platelet rich fibrin (i-PRF) in treatment of female stress urinary incontinence and comparing the need for re-injection in the two groups.
- Conditions
- Female Stress Urinary Incontinence
- Being tested
- Platelet Rich Plasma, Platelet rich fibrin
- Keywords
- PRP- i-PRF- SUI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich PlasmaBiological
Approximately 5 mL of PRP will be injected at three points (on both sides of the urethra and urethrovaginal space) under local anesthesia. Injections will be performed by gynecologist in the outpatient clinic.
Platelet rich fibrinBiological
Approximately 5 mL of i-PRF will be injected at three points (on both sides of the urethra and urethrovaginal space) under local anesthesia. Injections will be performed by gynecologist in the outpatient clinic
| Study group | Role | What they receive |
|---|---|---|
| group one who had received PRP injections | Active comparator | Not described Receives: Biological: Platelet Rich Plasma |
| group two who had received i-PRF injections | Active comparator | Not described Receives: Biological: Platelet rich fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in the severity of SUI measured by Incontinence Impact Questionnaire (IIQ7)
Measured: baseline and three and six months follow up
Secondary outcomes (1)
changes in the severity of SUI using 10 point visual analogue scale
Measured: baseline and three and six months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start10 Jul 2024
- Primary completion1 May 2025
- Study completion2 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Reda Mohamed Gebril, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366762
- Sponsor's protocol ID
- KFSIRB200-320
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Effect of Periurethral Injection of Platelet-rich Plasma VS Platelet Rich Fibrin in Treatment of Female Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT07366762
- Acronym / sponsor ID
- KFSIRB200-320
- Conditions
- Female Stress Urinary Incontinence
- Keywords
- PRP- i-PRF- SUI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 2 Jan 2026 (actual)
- First posted
- 26 Jan 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.
compare the therapeutic effect of periurethral injection of autologous platelet-rich plasma (PRP) and injectable platelet rich fibrin (i-PRF) in treatment of female stress urinary incontinence and comparing the need for re-injection in the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group one who had received PRP injections | Active comparator | Biological: Platelet Rich Plasma |
| group two who had received i-PRF injections | Active comparator | Biological: Platelet rich fibrin |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female patients with primary symptoms of SUI confirmed by patient's medical history and clinical examination, including a focused incontinence evaluation
Key exclusion criteria (5 listed)
- Residual urine volume exceeding 100 cc after excretion
- Evidence of detrusor over-activity on the urodynamic test
- Active urinary tract or vaginal infection
- Malignancies of the genitourinary system
- Patients with genitourinary fistula or urethral diverticulum
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 PlasmaApproximately 5 mL of PRP will be injected at three points (on both sides of the urethra and urethrovaginal space) under local anesthesia. Injections will be performed by gynecologist in the outpatient clinic. | Biological | group one who had received PRP injections |
| Platelet rich fibrinApproximately 5 mL of i-PRF will be injected at three points (on both sides of the urethra and urethrovaginal space) under local anesthesia. Injections will be performed by gynecologist in the outpatient clinic | Biological | group two who had received i-PRF injections |
Primary outcome
changes in the severity of SUI measured by Incontinence Impact Questionnaire (IIQ7)
Time frame: baseline and three and six months follow up
1 secondary outcome
changes in the severity of SUI using 10 point visual analogue scale
Time frame: baseline and three and six months follow up
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 26 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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?
A Phase 3 study testing Platelet Rich Plasma and Platelet rich fibrin in people with Female Stress Urinary Incontinence, run by Kafrelsheikh 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 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 26 Jan 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.
What does this phase mean?
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?
changes in the severity of SUI measured by Incontinence Impact Questionnaire (IIQ7) (time frame: baseline and three and six months follow up). 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 26 Jan 2026.