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Comparison between autologous platelet rich plasma (PRP) and supervised pelvic floor muscle training (PFMT) in stress urinary incontinence: A multicenter randomized trial

Comparison between autologous platelet rich plasma (PRP) and supervised pelvic floor muscle training (PFMT) in stress urinary incontinence: A multicenter randomized trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250501001
Enrollment
80
Registered
2025-05-01
Start date
2025-05-02
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress urinary incontinence Urinary Incontinence, Stress

Interventions

Ten millilitres of peripheral blood will be drawn and processed using a standardised, closed-system centrifugation method to yield 5 mL of PRP. The final product will be injected into the periurethral
clock positions around the proximal, mid, and distal urethra. Repeat injection after 4 weeks (total 2 injection).,Supervised PFMT according to the International Urogynecological Association recommenda
Experimental Procedure/Surgery,Active Comparator Behavioral
Platelet-rich plasma (PRP) injection,Pelvic floor muscle training (PFMT)

Sponsors

Department of Obstetrics and Gynaecology, Faculty of Medicine, Khon Kaen Univerisity
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Women aged 18-70 years with stress urinary incontinence mixed urinary incontinence with stress incontinence as the predominant symptom 2) A 1-hour pad test result between 1 g and 50 g

Exclusion criteria

Exclusion criteria: 1) Currently pregnant 2) Presence of urinary retention 3) Prior surgical treatment for stress urinary incontinence, or non-surgical treatment within the past 3 months such as laser, radiofrequency, or PRP therapy 4) Coagulopathy 5) Pelvic organ prolapse greater than stage 2 based on the Pelvic Organ Prolapse Quantification system (POP-Q) 6) Ongoing treatment for gynecologic cancer 7) Presence of genital fistula 8) History of recurrent urinary tract infections (recurrent cystitis), based on patient history and/or laboratory results if available (including cases of self-treatment) 9) Unexplained abnormal vaginal bleeding 10) Current use of corticosteroids or immunosuppressants 11) Current use of topical estrogen 12) Inability to perform pelvic floor muscle training or levator ani muscle strength graded 0 on pelvic examination

Design outcomes

Primary

MeasureTime frame
1-hour pad test 3 and 6 months 1-hour pad test

Secondary

MeasureTime frame
UDI-6 3 and 6 months UDI-6 questionnaire,King Health questionnaire 3 and 6 months King Health questionnaire,ICIQ-UI SF 3 and 6 months ICIQ-UI SF questionnaire,Satisfaction 3 and 6 months visual analog scale

Countries

Thailand

Contacts

Public ContactTeerayut Temtanakitpaisan

Khon Kaen University

teerte@kku.ac.th043363030

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026