Background: Stress urinary incontinence (SUI) is the involuntary leakage of urine during activities that increase intra-abdominal pressure such as coughing, sneezing, laughing, or exercise. It is commonly seen in middle-aged and elderly women and significantly affects quality of life. Platelet-Rich Plasma (PRP) is an autologous, safe, and cost-effective regenerative therapy that may improve urethral support and sphincter function. Aim: To evaluate the efficacy and safety of periurethral autologous Platelet-Rich Plasma injections in women with stress urinary incontinence. Methods: This prospective pilot interventional study was conducted in the Department of Obstetrics and Gynaecology, Government Doon Medical College, Dehradun, on 15 women diagnosed with stress urinary incontinence. Women aged 25–45 years fulfilling inclusion criteria were enrolled after informed consent and institutional ethical approval. Two periurethral PRP injections were administered at an interval of 6 weeks. Improvement was assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), cough stress test, and 3-day bladder diary over a follow-up period of 6 months. Results: Most patients belonged to the 40–44 years age group. Mild SUI was observed in 9 patients and moderate SUI in 6 patients. Patients with mild SUI showed better improvement after PRP therapy. Improvement in urinary symptoms and voiding diary findings was noted after 6 months. No major adverse events were reported during the study period. Conclusion: Periurethral PRP injection appears to be a safe, minimally invasive, and effective treatment option for mild to moderate female stress urinary incontinence. Larger randomized controlled trials are required to validate these findings.
Stress urinary incontinence (SUI) is defined as the involuntary leakage of urine during physical activities that increase intra-abdominal pressure such as coughing, sneezing, laughing, lifting heavy objects, or exercise. It is one of the most common types of urinary incontinence affecting women and has a significant impact on physical, psychological, and social well-being. Women suffering from SUI often experience embarrassment, reduced self-confidence, social isolation, and restriction of daily activities, which ultimately affects their overall quality of life. The prevalence of urinary incontinence increases with advancing age due to menopause, weakening of pelvic floor muscles, multiparity, obesity, chronic cough, constipation, and associated comorbidities such as diabetes mellitus and chronic respiratory diseases.¹-3
Stress urinary incontinence affects nearly 20% of adult women and remains an important public health concern worldwide. In an Indian study, the overall frequency of urinary incontinence was found to be 21.87%.¹ Another hospital-based survey conducted in Indian women also identified age more than 40 years, multiparity, postmenopausal status, body mass index greater than 25, diabetes mellitus, bronchial asthma, and chronic constipation as important risk factors associated with increased prevalence of urinary incontinence.⁴ The prevalence is especially high among women older than 65 years because of postmenopausal hormonal changes, decreased estrogen levels, and reduced pelvic floor support.²
Various treatment modalities are available for the management of SUI, including lifestyle modifications, pelvic floor muscle training, behavioral therapy, pharmacological treatment, urethral bulking agents, and surgical procedures such as mid-urethral sling operations. These treatments mainly aim to restore urethral support and improve sphincter function. However, surgical treatment is often associated with intraoperative and postoperative complications such as bleeding, infection, urinary retention, pain, and mesh-related complications, along with increased cost and prolonged recovery time. Therefore, minimally invasive and regenerative treatment options are being increasingly explored. ⁵
Platelet-Rich Plasma (PRP) is an autologous concentration of platelets derived from the patient’s own blood and contains a high concentration of growth factors, cytokines, and bioactive proteins that play an important role in tissue healing and regeneration. The growth factors released from activated platelets help regulate tissue repair, collagen synthesis, angiogenesis, fibroblast proliferation, and cellular remodeling, thereby facilitating restoration of urethral support and sphincter function.⁶˒⁷ PRP is relatively inexpensive, easy to prepare, safe, and may offer advantages over synthetic materials because it carries minimal risk of foreign body reaction, allergy, or major adverse effects.⁵-⁷ Due to its regenerative potential, PRP has gained increasing attention in the treatment of various gynecological and urological disorders.
Recently, periurethral PRP injection has emerged as a promising minimally invasive treatment option for female stress urinary incontinence. It offers the advantage of tissue regeneration without the complications associated with synthetic bulking agents or major surgery. Several studies have demonstrated significant improvement in SUI symptoms, reduction in urine leakage, improved pad test results, and better quality of life following PRP therapy.8-10 PRP has also shown encouraging results in improving urethral sphincter function in women with intrinsic sphincter deficiency and mild to moderate grades of stress urinary incontinence.
The present study was conducted to evaluate the outcome of periurethral injections of autologous Platelet-Rich Plasma over a period of 6 months in women with stress urinary incontinence and to determine its effectiveness as a safe, minimally invasive, and cost-effective treatment modality.
This prospective pilot interventional study was conducted in the Department of Obstetrics and Gynaecology, Government Doon Medical College, Dehradun, to evaluate the efficacy and safety of periurethral autologous Platelet-Rich Plasma (PRP) injections in women diagnosed with Stress Urinary Incontinence (SUI).
A total of 15 female patients aged 25–45 years with predominant symptoms of stress urinary incontinence were enrolled in the study after obtaining approval from the Institutional Ethics Committee. Written informed consent was obtained from all participants before recruitment.
Patient Evaluation
A detailed clinical history was taken for each patient, and risk factors associated with stress urinary incontinence were assessed using a structured questionnaire. The parameters included age, menopausal status, body mass index (BMI), parity, mode of delivery (normal vaginal delivery, instrumental delivery, or caesarean section), birth weight of the largest child, use of episiotomy, physical activity, smoking, diabetes mellitus, chronic constipation, bronchial asthma, chronic obstructive pulmonary disease, and use of medications such as diuretics and antidepressants.
Routine investigations were performed for pre-anaesthetic evaluation and to confirm fitness for the procedure. Urinary complaints were assessed using a 3-day frequency-volume bladder diary. The same diary was repeated after 6 months to evaluate improvement in symptoms.
The cough stress test was performed with the bladder filled up to 300 mL with normal saline. The test was considered positive if visible urine leakage occurred during coughing.
Symptom severity and treatment response were further
assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF).
Inclusion Criteria
Exclusion Criteria
Preparation of Platelet-Rich Plasma (PRP)
Under strict aseptic precautions, 20 mL of venous blood was drawn from the patient using a heparinized syringe. Heparin was used in a 1:10 ratio as an anticoagulant.
The collected blood sample was first centrifuged at 2200 rpm for 12 minutes to separate red blood cells from plasma and platelets. The supernatant plasma along with the buffy coat containing platelets was collected and centrifuged again at 1800 rpm for 5 minutes. The lower buffy layer containing concentrated Platelet-Rich Plasma was then collected for injection.
Peri urethral PRP Injection Technique
The urinary bladder was emptied completely before the procedure, and the patient was placed in the lithotomy position. Local anaesthesia using 0.5–1.0 mL of 1% lidocaine was administered on both sides of the urethra.
A 22-gauge spinal needle attached to a 5 mL syringe was introduced parallel to the urethra using a Foley catheter as a guide. The needle was advanced to the desired periurethral submucosal plane. PRP was then injected at the 3 o’clock, 6 o’clock, and 9 o’clock positions around the urethra, with approximately 1 mL injected at each site.
Two sessions of periurethral PRP injection were administered with an interval of 6 weeks between injections.
Follow-up and Outcome Assessment
Patients were followed up at 1 week, 4 weeks, 8 weeks, 12 weeks, and 6 months after the procedure. Improvement was assessed based on:
Any adverse events or complications related to the procedure were also recorded.
Statistical Analysis
Data were entered into Microsoft Excel and analyzed using SPSS version 25.0. Continuous variables were expressed as mean ± standard deviation (SD), while categorical variables were presented as frequencies and percentages. Pre- and post-treatment comparisons were assessed using paired t-test for continuous variables and McNemar test for categorical variables wherever applicable. A p-value of <0.05 was considered statistically significant.
A total of 15 women diagnosed with Stress Urinary Incontinence (SUI) were enrolled in this prospective pilot interventional study. The mean age of the patients was 35 years (range: 25–45 years), and the median duration of symptoms was 3–4 years (range: 1–5 years). Most of the patients were multiparous and had associated risk factors such as obesity, chronic cough, constipation, and diabetes mellitus.
The age-wise distribution of patients is shown in Table 1. Most patients belonged to the 40–44 years age group, accounting for 6 patients (40.0%), followed by the 30–34 years age group with 4 patients (26.7%). Three patients (20.0%) were in the 35–39 years age group, while 2 patients (13.3%) belonged to the 24–29 years age group.
Table 1: Distribution of Patients According to Age Group
|
Age Group (Years) |
Number of Patients |
Percentage |
|
24–29 |
2 |
13.3% |
|
30–34 |
4 |
26.7% |
|
35–39 |
3 |
20.0% |
|
40–44 |
6 |
40.0% |
|
Total |
15 |
100% |
The severity-wise distribution of stress urinary incontinence is presented in Table 2. Mild SUI was the most common presentation and was observed in 9 patients (60.0%), whereas moderate SUI was seen in 6 patients (40.0%). No cases of severe SUI were included in the present study. Mild SUI was commonly seen in patients with parity P2, while moderate SUI was more commonly associated with parity P3.
Table 2: Distribution of Patients According to Severity of Stress Urinary Incontinence
|
Grade of SUI |
Number of Patients |
Common Parity |
|
Mild |
9 |
P2 |
|
Moderate |
6 |
P3 |
|
Severe |
0 |
— |
|
Total |
15 |
— |
The associated risk factors observed among the study participants are shown in Table 3. Multiparity was the most common risk factor, present in 10 patients (66.7%), followed by obesity in 6 patients (40.0%), chronic cough in 5 patients (33.3%), constipation in 4 patients (26.7%), and diabetes mellitus in 3 patients (20.0%).
Table 3: Associated Risk Factors Observed in Patients with SUI
|
Risk Factor |
Number of Patients |
Percentage |
|
Multiparity |
10 |
66.7% |
|
Obesity |
6 |
40.0% |
|
Chronic Cough |
5 |
33.3% |
|
Constipation |
4 |
26.7% |
|
Diabetes Mellitus |
3 |
20.0% |
Treatment response after periurethral PRP therapy was assessed at 6 months follow-up using symptom relief, reduction in urinary leakage episodes, improvement in International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) scores, cough stress test findings, and 3-day bladder diary records. Patients with mild SUI showed better improvement compared to those with moderate SUI.
As shown in Table 4, reduction in urinary leakage episodes was observed in 11 patients (73.3%), improvement in urinary stream was noted in 10 patients (66.7%), improvement in ICIQ-SF score was seen in 12 patients (80.0%), and a negative cough stress test was observed in 9 patients (60.0%).
Table 4: Improvement in Symptoms After PRP Therapy at 6 Months Follow-up
|
Clinical Outcome |
Improved Patients |
Percentage |
|
Reduction in urinary leakage |
11 |
73.3% |
|
Improvement in urinary stream |
10 |
66.7% |
|
Improvement in ICIQ-SF score |
12 |
80.0% |
|
Negative cough stress test |
9 |
60.0% |
No major complications or adverse events were reported following PRP injections. The procedure was well tolerated by all patients. No cases of urinary retention, urinary tract infection, significant pain, or allergic reaction were observed during the follow-up period.
Stress urinary incontinence (SUI) is a common condition among women and significantly affects quality of life, daily activities, and psychological well-being. In the present study, periurethral Platelet-Rich Plasma (PRP) injection showed promising results in the management of mild to moderate female SUI. Most patients demonstrated improvement in urinary symptoms, reduction in urinary leakage episodes, better ICIQ-SF scores, and improvement in bladder diary findings after 6 months of follow-up. No major complications or adverse events were observed, suggesting that PRP is a safe and minimally invasive treatment option.
The most common risk factors observed in our study were multiparity, obesity, chronic cough, constipation, and diabetes mellitus. Similar findings were reported by Mainu et al., where chronic cough, constipation, obesity, and diabetes were identified as important contributors to urinary incontinence in women¹. Tai et al. also observed that chronic constipation, immobility, and previous surgeries were significant risk factors associated with urinary incontinence in elderly women residing in nursing homes². Singh et al. reported that age more than 40 years, multiparity, postmenopausal status, body mass index greater than 25, diabetes, asthma, and certain lifestyle habits were significantly associated with increased prevalence of urinary incontinence in Indian women⁸.
In the present study, patients with mild SUI showed better clinical improvement compared to those with moderate SUI. This may be due to better residual sphincter function and less severe urethral support defects in early-stage disease. Similar positive outcomes have been reported in previous studies evaluating PRP for SUI. Pitsillidi et al., in a scoping review of ten studies involving 273 patients, reported significant improvement in symptoms of SUI following PRP therapy and highlighted its role as a promising personalized treatment approach³.
Athanasiou et al. reported nearly 50% reduction in urine loss on the one-hour pad test after PRP treatment, supporting the effectiveness of PRP as a nonsurgical treatment modality for female SUI⁴. Jiang et al. also demonstrated that complete dryness was achieved in several patients, with significant reduction in Visual Analog Scale (VAS) scores after urethral sphincter PRP injections in patients with intrinsic sphincter deficiency⁵. These findings are consistent with the improvement observed in our study population.
Injection therapy has been increasingly used as a minimally invasive alternative to surgical correction of SUI, including urethral bulking agents and regenerative therapies such as stem cell formulations⁶. PRP offers an advantage because it is autologous, easily prepared, inexpensive, and has minimal risk of foreign body reaction or immunological complications. The growth factors, cytokines, and bioactive proteins present in PRP promote tissue healing, collagen remodeling, angiogenesis, and regeneration of periurethral tissues, thereby improving urethral support and sphincter function⁷.
Recent randomized controlled trials have further strengthened the evidence for PRP in SUI management. Saraluck et al. demonstrated significant improvement in pad test outcomes when PRP was combined with pelvic floor muscle training, without major adverse effects⁹. Similarly, Grigoriadis et al. reported that periurethral PRP injections were superior to sham treatment in controlling stress urinary incontinence and improving patient-reported outcomes¹⁰.
The major strength of the present study is that it evaluates PRP as a safe, office-based, minimally invasive treatment option for female SUI with encouraging short-term outcomes. However, the study is limited by small sample size, short follow-up duration, and absence of a control group. Larger randomized controlled trials with longer follow-up are required to establish the long-term efficacy and standardization of PRP therapy in stress urinary incontinence.
Overall, PRP appears to be a safe, autologous, and cost-effective regenerative therapy for the treatment of mild to moderate female stress urinary incontinence, particularly in patients seeking nonsurgical alternatives.,
Periurethral Platelet-Rich Plasma (PRP) injection appears to be a safe, minimally invasive, and effective treatment option for women with mild to moderate stress urinary incontinence (SUI). In the present study, most patients showed improvement in urinary symptoms, reduction in leakage episodes, better ICIQ-SF scores, and improvement in bladder diary findings after 6 months of follow-up. Patients with mild SUI demonstrated better clinical response compared to those with moderate SUI. No major adverse events or complications were observed, highlighting the safety and tolerability of the procedure. PRP, being autologous, cost-effective, and easy to prepare, offers a promising nonsurgical alternative for the management of female SUI. However, larger randomized controlled trials with longer follow-up periods are required to confirm these findings and establish standardized treatment protocols.