Stress Incontinence, FemaleNCT06885463
PRP & PDO Threads in Treatment of Stress Incontinence
A study testing platelets rich plasma combined with PDO threads in people with Stress Incontinence, Female, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The study will include 10 women with pure or predominant SUI symptoms, with severe urodynamic stress incontinence on urodynamics defined as loss of urine with sudden increases in abdominal pressure: eg, coughing, sneezing, or laughing). Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Stress Incontinence, Female
- What is being tested?
- platelets rich plasma combined with PDO threads
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 30 Jun 2025
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Nonpregnant Women with SUI
- Age between 20 to 45 years
- Patients had a history of failed conservative treatment
- Patients were on the waiting list for surgical treatment of SUI
Who cannot join
- Under anti-platelet agent treatment
- Under NSAIDs
- Platelet dysfunction syndrome
- Critical thrombocytopenia
- Hypofibrionogenaemia
- Sepsis
Show all 15Show fewer
- Acute and chronic infections
- Chronic liver disease
- Anti-coagulation therapy
- History of malignancy
- Pregnancy
- history of active malignant pathology
- mental disorders making them unable to give consent
- genitourinary fistula
- pelvic organs prolapse stage >2 according to the Pelvic Organ Prolapse Quantification system, and detrusor overactivity on urodynamics.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Faculty of Medicine, Al-Azhar University.
Cairo
Asem Moussa, Professor, +201001414226, dramoussa77@hotmail.com
About this study
Official title: The Role of Platelets Rich Plasma Combined With PDO Threads in Treatment of Stress Incontinence in Egyptian Women
The study will include 10 women with pure or predominant SUI symptoms, with severe urodynamic stress incontinence on urodynamics defined as loss of urine with sudden increases in abdominal pressure: eg, coughing, sneezing, or laughing). This will be conducted at the Department of Obstetrics and Gynecology, Faculty of Medicine, Al-Azhar University. The purpose of study is to evaluate the efficacy and safety of platelets rich plasma combined with PDO threads in the treatment of stress incontinence in Egyptian women.
- Conditions
- Stress Incontinence, Female
- Being tested
- platelets rich plasma combined with PDO threads
- 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.
platelets rich plasma combined with PDO threadsProcedure or surgery
- Injections of platelets-rich plasma in the Anterior Vaginal Wall.
- PDO thread placement in the paraurethral, lateral urethrovaginal, and suburethral areas
| Study group | Role | What they receive |
|---|---|---|
| platelets rich plasma combined with PDO threads | Experimental | Not described Receives: Procedure: platelets rich plasma combined with PDO threads |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of reported SUI symptoms
subjective evaluation of reported SUI symptoms, indicated by the patient's response to question of the ICIQ-FLUTS questionnaire: "Does urine leak when you are physically active, exert yourself, cough or sneeze?"
Measured: After 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Mar 2025
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Incontinence, FemaleStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asem Anwar Moussa, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885463
- Sponsor's protocol ID
- 00000501
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Platelets Rich Plasma Combined With PDO Threads in Treatment of Stress Incontinence in Egyptian Women
- ClinicalTrials.gov ID
- NCT06885463
- Acronym / sponsor ID
- 00000501
- Conditions
- Stress Incontinence, Female
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 20 Mar 2025 (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.
The study will include 10 women with pure or predominant SUI symptoms, with severe urodynamic stress incontinence on urodynamics defined as loss of urine with sudden increases in abdominal pressure: eg, coughing, sneezing, or laughing). This will be conducted at the Department of Obstetrics and Gynecology, Faculty of Medicine, Al-Azhar University. The purpose of study is to evaluate the efficacy and safety of platelets rich plasma combined with PDO threads in the treatment of stress incontinence in Egyptian women.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| platelets rich plasma combined with PDO threads | Experimental | Procedure: platelets rich plasma combined with PDO threads |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Nonpregnant Women with SUI
- Age between 20 to 45 years
- Patients had a history of failed conservative treatment
- Patients were on the waiting list for surgical treatment of SUI
Key exclusion criteria (15 listed)
- Under anti-platelet agent treatment
- Under NSAIDs
- Platelet dysfunction syndrome
- Critical thrombocytopenia
- Hypofibrionogenaemia
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 |
|---|---|---|
| platelets rich plasma combined with PDO threads1. Injections of platelets-rich plasma in the Anterior Vaginal Wall. 2. PDO thread placement in the paraurethral, lateral urethrovaginal, and suburethral areas | Procedure or surgery | platelets rich plasma combined with PDO threads |
Primary outcome
evaluation of reported SUI symptoms
Time frame: After 4 months
subjective evaluation of reported SUI symptoms, indicated by the patient's response to question of the ICIQ-FLUTS questionnaire: "Does urine leak when you are physically active, exert yourself, cough or sneeze?"
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 20 Mar 2025.
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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.
Department of Obstetrics and Gynecology, Faculty of Medicine, Al-Azhar University.
Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing platelets rich plasma combined with PDO threads in people with Stress Incontinence, Female, run by Al-Azhar 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 4 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 20 Mar 2025. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of reported SUI symptoms (time frame: After 4 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 20 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.