PRP & PDO Threads in Treatment of Stress Incontinence
ConditionStress Incontinence, Female
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-45
SponsorAl-Azhar University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Under anti-platelet agent treatment
Under NSAIDs
Platelet dysfunction syndrome
Critical thrombocytopenia
Trial design
Design model
Single group
Treatments tested in this trial
platelets rich plasma combined with PDO threads
Procedure/Surgery1. Injections of platelets-rich plasma in the Anterior Vaginal Wall. 2. PDO thread placement in the paraurethral, lateral urethrovaginal, and suburethral areas
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: platelets rich plasma combined with PDO threadsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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?"
Time frame
After 4 monthsSponsors and contacts
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Source ClinicalTrials.gov