Status:
COMPLETED
Platelet-Rich Plasma for Stress Urinary Incontinence
Lead Sponsor:
Annah J. Vollstedt
Conditions:
Urinary Incontinence,Stress
Urinary Incontinence
Eligibility:
FEMALE
18-99 years
Phase:
PHASE3
Brief Summary
The aim of this randomized controlled trial study is to evaluate the efficacy and safety of platelet-rich plasma (PRP) in the treatment of female stress urinary incontinence (SUI), compared to placebo...
Detailed Description
Platelet-rich plasma (PRP) is an autologous solution of human plasma with a high concentration of platelets. While the preparation and injection of PRP is not a new technology, it has not been well-st...
Eligibility Criteria
Inclusion
- Women aged 18 years or older
- Pure or stress-predominant urinary incontinence with the Medical, Epidemiologic, and Social Aspects of Aging questionnaire (MESA) stress incontinence symptom score greater than MESA urge incontinence symptom score
- Observation of leakage by provocative stress test at bladder volume £ 300 mL \[15\]
- Post void residual \< 150 mL
Exclusion
- Currently pregnant or trying to conceive
- Currently breastfeeding
- Interstitial cystitis
- Urgency urinary incontinence predominance or currently being treated for overactive bladder with medication, percutaneous tibial nerve stimulation, bladder chemodenervation, or sacral neuromodulation
- Currently being treated for a sexually transmitted disease
- Pelvic organ prolapse greater than stage 2 according to the Pelvic Organ Prolapse Quantification System
- Periurethral mass
- Active gynecologic, urologic or colorectal cancer
- History of pelvic radiation
- Psychological disorder making the patient unable to provide consent
- Undiagnosed abnormal uterine bleeding
- Genitourinary fistula
- Prior SUI surgery
- Use of anti-platelet or anti-coagulant medication
- Regular use of non-steroidal anti-inflammatorie
Key Trial Info
Start Date :
May 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05390970
Start Date
May 23 2022
End Date
December 13 2023
Last Update
August 29 2024
Active Locations (1)
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1
University of Iowa
Iowa City, Iowa, United States, 52242