NCT07550426

Brief Summary

this study used to compare efficacy between platelet rich plasma periurethral injection versus mid urethral sling ( trans obturator tape ) in treatment of stress urinary incontinence

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Apr 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Apr 2026Dec 2027

Study Start

First participant enrolled

April 15, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 24, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

April 24, 2026

Status Verified

October 1, 2025

Enrollment Period

1 year

First QC Date

April 18, 2026

Last Update Submit

April 18, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • objective assessment of SUI through cough stress test

    after one and three months

Study Arms (1)

patients complaining of stress urinary incontinence based on urodynamic study

EXPERIMENTAL

GROUP 1: 21 patients allocated who have SUI ISD will receive PRP GROUP 2: 21 patient who have hypermobile urethra will receive TOT

Procedure: Platelet Rich PlasmaProcedure: Mid urethral sling ( trans obturator tape)

Interventions

GROUP 1 : 21patient will have platelet rich plasma injected periurethral in intrinsic muscle weakness in stress urinary incontinence

patients complaining of stress urinary incontinence based on urodynamic study

GROUP 2 : (21) patient having SUI due to hypermobile urethra will have TOT

patients complaining of stress urinary incontinence based on urodynamic study

Eligibility Criteria

Age26 Years - 66 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsbecause it depend on female genitourinary system urethral anatomy
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stress urinary incontinence identified by urodynamic study
  • patient agreement to undergo surgical treatment

You may not qualify if:

  • previous GUS operation
  • evidence of detrusor overactivity urinary system
  • presence of pelvic organ prolapse
  • malignancies of genitourinary system
  • history of hemorrhagic disorders , on anti platelet treatment , uncontrolled diabetes mellitus .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Suburethral Slings

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • mohamed Abdelhamid nasr El Din, Doctor of medicine

    urogynecology unit ainshams university

    STUDY DIRECTOR

Central Study Contacts

nahla fathy khatab, master of science

CONTACT

mahmoud mohamed Ghaleb, Doctor of medicine

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: randomized controlled clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2026

First Posted

April 24, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

April 15, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

April 24, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

in informed consent all participants information will be only known by the research and investigator committee and their personal information will be kept with confidentiality