Assessment of Platelet Rich Plasma Injection in Managing Female Patients Complaining of Mixed Urinary Incontinence (PRP)

NCT ID: NCT06769074

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-28
• Study Completion Date: 2025-12-01

Brief Summary

The goal of this clinical trial is to assess the efficacy of platelet-rich plasma (PRP) for the treatment of mixed urinary incontinence determine .The main question it aims to answer whether PRP is it safe and effective in managing mixed urinary incontinence? Researchers will assess efficacy of PRP in both stress and urgency incontinence treatment

Participants will:

• Undergo PRP injection in to mid urethra , and installation into bladder every 1 month for 3 month
• Visit the clinic once every 1 month for checkups and urodynamic study after 3 month, and 4 month after last installation

Detailed Description

All patients will be subjected to:

• An informed consent will be taken from every patient.
• Complete history taking:

• Personal history
• Any complaint.
• Past medical and past surgical history.
• Family history.
• Severity of incontinence by International consultation on incontinence questionnaire- short form (ICIQ-SF), OAB symptom score ,Cough stress test

*Complete physical examination.

• General examination: Vital signs (Blood pressure, Temperature, Heart rate, Respiratory rate).
• neurological examination: gait, perineal sensation, bulbocavernous reflex, cognitive status
• abdominal examination : distended bladder, masses , hernia, DRE
• Pelvic examination: vaginal atrophy, skin excoriation, vault examination, organ prolapse, pelvic floor muscle strength , cough test, Q tip test, Marshall test
• urodynamics done for documentation of detrusor overactivity before and after PRP installation after 3rd instillation and 4 m after last instillation

• patient is placed in the dorsal lithotomy position
• PRP is obtained from a sample of patients' blood drawn at the time of treatment
• A 30 cc venous blood draw will yield 3-5 cc of PRP
• The blood draw occurs with the addition of an anticoagulant, such as citrate dextrose A( .5 ml)to prevent platelet activation prior to its use
• in room temp 21-24 to avoid activation of platelet
• a specialized 'table top cold centrifuge' device to centrifugate the sample
• After centrifugation, each vial was confirmed to contain three layers from top to bottom, namely, the platelet pellet, gel, and red blood cells. The platelet pellet was remixed with the supernatant by inverting the tubes gently 5-10 times.
• A-PRP was injected into the anterior vaginal mucosa around the mid-urethral area, which was approximately 1 cm below the urethral meatus and had a depth of about 1.5 cm; 2 mL were injected underneath the mid-urethral area and 1.5 mL was injected on either side of the urethra
• 10ml PRP used to instill intravesical for urgency urinary incontinence by urethral catheter
• patient received four injections of PRP at monthly intervals
• follow up done after 3rd instillation and 4 months after finishing injections
• follow up done by subjective symptoms as previous scoring system and objective by Urodynamics

Conditions

Mixed Urinary Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PRP injection at midurethra with PRP instillation into urinary bladder

A-PRP was injected into the anterior vaginal mucosa around the mid-urethral area, which was approximately 1 cm below the urethral meatus and had a depth of about 1.5 cm; 2 mL were injected underneath the mid-urethral area and 1.5 mL was injected on either side of the urethra

*10ml PRP used to instill intravesical for urgency urinary incontinence by urethral catheter

Group Type: EXPERIMENTAL

Platelet Rich Plasma

Intervention Type: BIOLOGICAL

PRP injection into the midurethra and its instillation into urinary bladder

Interventions

Platelet Rich Plasma

PRP injection into the midurethra and its instillation into urinary bladder

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Women with MUI ( mild and moderate degree of stress incontinence)
• Age between 20 to 60 years -

Exclusion Criteria

• intrinsic sphincteric deficiency (ISD)
• Pregnancy
• Sepsis
• Acute and chronic infections
• Chronic liver disease
• Anti-coagulation therapy
• History of malignancy
• Under anti-platelet agent treatment

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zagazig University

Egypt, , Egypt

Zagazig university hospital , Egypt

Zagazig, , Egypt

Countries

Egypt

Other Identifiers

782/29-oct-2024

Identifier Type: -

Identifier Source: org_study_id