Peri-Urethral Platelet-Rich Plasma Injections for Postmenopausal Female Stress Urinary Incontinence

NCT07807982 | Not Yet Recruiting

• 1 other identifier: MS.25.7.2026
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

his prospective interventional study will evaluate the effectiveness and safety of peri-urethral injections of platelet-rich plasma for treating stress urinary incontinence in postmenopausal women. Platelet-rich plasma is prepared from each participant's own blood and contains concentrated platelets and growth factors that may promote tissue repair and regeneration. Approximately 70 postmenopausal women with stress urinary incontinence will receive peri-urethral platelet-rich plasma injections once monthly for four consecutive months. Platelet-rich plasma will be injected into five sites around the urethra. Participants will be followed after treatment to assess improvement in urinary leakage and urinary symptoms, changes in urodynamic measurements, and treatment-related adverse events. The study aims to determine whether repeated peri-urethral platelet-rich plasma injections can provide a safe and effective minimally invasive treatment option for postmenopausal women with stress urinary incontinence.

Conditions

Stress Urinary Incontinence

Keywords

Postmenopausal Women; Platelet-Rich Plasma; Peri-Urethral Injection; Intrinsic Sphincter Deficiency; Urethral Sphincter; Urinary Incontinence; Urodynamic Evaluation; Regenerative Therapy

Outcome Measures

Primary Outcomes (1)

• Treatment Success Based on Global Response Assessment Score

  Treatment response will be assessed using the Global Response Assessment score, which ranges from -3 to +3. A score of -3 indicates markedly worse symptoms, -2 indicates moderately worse symptoms, -1 indicates mildly worse symptoms, 0 indicates no change, +1 indicates mild improvement, +2 indicates moderate improvement, and +3 indicates marked improvement. Treatment success will be defined as a Global Response Assessment score of +2 or +3. The result will be reported as the number and percentage of participants achieving treatment success.

  1 month after the fourth platelet-rich plasma injection

Secondary Outcomes (9)

• Dry Rate

  1, 3, and 6 months after the fourth platelet-rich plasma injection

• Change in Stress Urinary Incontinence Severity Assessed by the Visual Analogue Scale

  Baseline through 6 months after the fourth platelet-rich plasma injection

• Change in Abdominal Leak Point Pressure

  Baseline and 3 months after the fourth platelet-rich plasma injection

• Change in Maximum Urinary Flow Rate

  Baseline and 3 months after the fourth platelet-rich plasma injection

• Change in Voided Urine Volume

  Baseline and 3 months after the fourth platelet-rich plasma injection

Study Arms (1)

Peri-Urethral Platelet-Rich Plasma Injection

EXPERIMENTAL

Participants will receive autologous platelet-rich plasma injections under local anesthesia. A total of 5 milliliters of platelet-rich plasma will be administered, with 1 milliliter injected at each of five peri-urethral submucosal sites corresponding to the 12, 2, 5, 7, and 10 o'clock positions. The injection procedure will be repeated once monthly for four consecutive months. Routine urinary catheterization will not be required after the procedure.

Biological: Autologous Platelet-Rich Plasma

Interventions

Autologous Platelet-Rich Plasma BIOLOGICAL

Autologous platelet-rich plasma will be prepared from 30 to 50 milliliters of peripheral blood using a two-step centrifugation technique. The first centrifugation will be performed at 200 × g for 20 minutes at 20 degrees Celsius, followed by a second centrifugation at 2000 × g for 20 minutes at 20 degrees Celsius. The final 5 milliliters of platelet-rich plasma, with an expected platelet concentration approximately 2.5 to 5 times the baseline platelet concentration, will be used for peri-urethral injection.

Peri-Urethral Platelet-Rich Plasma Injection

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women aged 45 years or older.
• Stress urinary incontinence confirmed by urodynamic study with intrinsic sphincter deficiency.
• Persistent stress urinary incontinence requiring pad use despite conservative management.
• Patients unfit for surgical intervention and anesthesia.
• Coagulation disorders or current anticoagulant therapy that cannot be safely discontinued.
• Patients with comorbidities.

You may not qualify if:

• Urinary tract infection.
• Neurological disorders affecting lower urinary tract function.
• Pelvic organ prolapse greater than stage II according to the Pelvic Organ Prolapse Quantification system.
• Previous urethral surgery.
• Inability or unwillingness to comply with follow-up visits.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospital

Banhā, Qalyubia Governorate, 13511, Egypt

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mina R Banoub, MBBCh

CONTACT

0 12 89930607; Minaraafatbanoob@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Urology

Model Details: All enrolled participants will receive peri-urethral injections of autologous platelet-rich plasma once monthly for four consecutive months and will be followed to evaluate treatment efficacy and safety.

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 8, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)