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

NCT06769074 | Active Not Recruiting

• 1 other identifier: 782/29-oct-2024
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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

Conditions

Mixed Urinary Incontinence

Keywords

Mixed urinary incontinence; Platelet rich plasma; stress urinary incontinence

Outcome Measures

Primary Outcomes (1)

• Number of females with treatment-related improvement of mixed urinary incontinence after receiving platelet-rich plasma (PRP) injection and instillation.

  Treatment -related improvement of urinary incontinence is assessed using: * International consultation on incontinence questionnaire- short form (ICIQ-SF). * OAB symptom score. * Cough stress test. * Urodynamics. 1. ICIQ-Sf questionnaire before and after treatment: Scoring scale: 0-21, minimum 0, maximum 21. A higher score indicates greater impairment from incontinence. 2. OAB symptom score: has a maximum score of 15 with more weight assigned to urgency and urgency incontinence than on frequency. Higher score indicates greater impairment from incontinence. 3. Urodynamics: for assessment of of detrusor over-activity before and after treatment.

  From enrollment to the end of intervention at 6 month "

Study Arms (1)

PRP injection at midurethra with PRP instillation into urinary bladder

EXPERIMENTAL

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

Biological: Platelet Rich Plasma

Interventions

Platelet Rich Plasma BIOLOGICAL

PRP injection into the midurethra and its instillation into urinary bladder

PRP injection at midurethra with PRP instillation into urinary bladder

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (2)

Zagazig University

Egypt, Egypt

Location

Zagazig university hospital , Egypt

Zagazig, Egypt

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 10, 2025
• Study Start: December 28, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 10, 2025

Record last verified: 2024-12

Locations

EG (2)