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Recruiting NCT06885463

PRP & PDO Threads in Treatment of Stress Incontinence

No phase Interventional Stress Incontinence, Female

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: platelets rich plasma combined with PDO threads.
Who it may be relevant to
Registry conditions: Stress Incontinence, Female. Basic parameters: 20 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Role of Platelets Rich Plasma Combined With PDO Threads in Treatment of Stress Incontinence in Egyptian Women

Overview

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.

Interventions

  • Procedure platelets rich plasma combined with PDO threads
    1. Injections of platelets-rich plasma in the Anterior Vaginal Wall. 2. PDO thread placement in the paraurethral, lateral urethrovaginal, and suburethral areas

Primary outcome measures

  • evaluation of reported SUI symptoms [Time frame: After 4 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Under anti-platelet agent treatment
  • Under NSAIDs
  • Platelet dysfunction syndrome
  • Critical thrombocytopenia
  • Hypofibrionogenaemia
  • Sepsis
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Department of Obstetrics and Gynecology, Faculty of Medicine, Al-Azhar University. — Cairo

Identifiers

NCT: NCT06885463 · 00000501

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗