NCT05295420

Brief Summary

Urinary incontinence can impact on one's social, physical, mental, and sexual wellbeing, and lead to depression and social isolation Stress urinary incontinence (SUI) refers to the involuntary leakage of urine accompanying physical exertion (i.e. coughing, exercise, and sneezing). It is commonly acquired after pregnancy and childbirth due to the weakening of the pelvic floor muscles that support the urethra against the anterior vaginal wall. Current SUI treatment includes surgery to re-establish sufficient urethral resistance in order to prevent urine leakage during increased intra-abdominal pressure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 27, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

February 27, 2022

Last Update Submit

July 6, 2023

Conditions

Stress Urinary IncontinenceUrinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • urinary incontinence severity by PRP treatment

    Assessment of urinary incontinence severity by visual analog scale as: from 0 -10,

    From baseline to 3 months after the PRP treatment day.

Secondary Outcomes (1)

  • Patients can control voiding on stress

    From baseline to first month and continued to 3 months after the treatment day

Study Arms (1)

platelet-rich plasma

EXPERIMENTAL

to assess the role of platelet-rich plasma in the treatment of SUI as a non-invasive method

Procedure: platelet rich plasma

Interventions

platelet rich plasmaPROCEDURE

Injection of Platelet Rich Plasma in the female conditions that suffer from SUI

platelet-rich plasma

Eligibility Criteria

Age35 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female patient with mild to moderate SUI

You may not qualify if:

  • Under anti-platelet agent treatment
  • Platelet dysfunction syndrome
  • Critical thrombocytopenia
  • Acute and chronic infections
  • Anti-coagulation therapy
  • History of malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SAYED GALAL HOSPITAL, AND AlGalaaTeaching HOSPITAL

Cairo, Egypt

Location

MeSH Terms

Conditions

Urinary Incontinence, StressUrinary Incontinence

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2022

First Posted

March 25, 2022

Study Start

March 1, 2022

Primary Completion

June 15, 2022

Study Completion

June 30, 2022

Last Updated

July 10, 2023

Record last verified: 2023-07

Locations

EG(1)