Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000524392
Ethics application status
Not required
Date submitted
16/12/2016
Date registered
10/04/2017
Date last updated
10/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Platelet-rich plasma (PRP) local injection for female sexual dysfunction
Scientific title
Platelet- rich plasma (PRP) local injection for female sexual dysfunction
Secondary ID [1] 290779 0
none
Universal Trial Number (UTN)
U1111-1191-0080
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sexual dysfunction 301377 0
Condition category
Condition code
Reproductive Health and Childbirth 301133 301133 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A small sample of blood (5ml) is withdrawn from the patient, then spun in a centrifuge to separate the blood into layers. The platelet-rich plasma layer is carefully extracted, then injected back into the anterior and posterior vaginal wall, G-spot and clitoris. the procedure will take about 10 minutes after local anaesthetic cream application.procedure will be done in the outpatient clinic by gynaecology specialist with minimum 3 years experience.patients will receive four times injections 2weeks a part.they will be evaluated by FSFI questionnaire after 2 months.
Intervention code [1] 296690 0
Treatment: Other
Comparator / control treatment
No control group' in this field
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300536 0
change in sexual function accessed by FSFIq before and after the procedure.
Timepoint [1] 300536 0
2 months after PRP injection
Secondary outcome [1] 330258 0
1-The incidence of vaginal infection assessed by self-report.
Timepoint [1] 330258 0
2 months after PRP injection.
Secondary outcome [2] 332097 0
2-change in urinary incontinence in patients complaining of incontinence.
will be assessed by ICIQ short form questionnaire.
Timepoint [2] 332097 0
2 months after PRP injection

Eligibility
Key inclusion criteria
sexually active females 18-60 years complaining of sexual dysfunction.
Minimum age
18 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1- psychological or mental illness.
2- male partner erectile dysfunction.
3- diabetic patients

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
pilot study
Statistical presentation and analysis of the study will be conducted using mean, standard deviation and chi-square test .

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/04/2017
Actual
Date of last participant enrolment
Anticipated
20/08/2017
Actual
Date of last data collection
Anticipated
30/10/2017
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 8513 0
Egypt
State/province [1] 8513 0
cairo

Funding & Sponsors
Funding source category [1] 295196 0
Hospital
Name [1] 295196 0
AL ZAHRAA UNIVERSITY HOSPITAL
Country [1] 295196 0
Egypt
Primary sponsor type
Individual
Name
DOAA MOHAMED SALEH
Address
ALZAHRAA UNIVEISITY HOSPITSL
ABASSIA
CAIRO
EGYPT
AZHAR UNIVERSITY
Country
Egypt
Secondary sponsor category [1] 294025 0
Individual
Name [1] 294025 0
TAISEER MAROUF
Address [1] 294025 0
PROFESSOR OB/GYN
AL ZAHRAA UNIVEROSITY HOSPITAL
ABASSIA
CAIRO
Country [1] 294025 0
Egypt

Ethics approval
Ethics application status
Not required

Summary
Brief summary
Platelet Rich Plasma (PRP) has been demonstrated to be effective and without serious side effects in multiple studies in the areas of wound care, orthopaedics, dental surgery and in a variety of cosmetic procedures.
PRP activates pluripotent stem cells in the area of injection resulting in rejuvenation and even enhancement of damaged or undamaged tissue. The aqueous nature of PRP allows injection through a small bore needle and an even distribution throughout the tissue surrounding the injection site.
women who presented with complaints of dyspareunia or other symptoms related to sexual dysfunction will be offered PRP injections into the periurethral area of the Skene's glands, vaginal wall
and the clitoris and will be observed for their responses to this treatment.
It will offer a cheap, easy, non-invasive and safe treatment for females with sexual dysfunction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71254 0
Dr doaa mohamed saleh
Address 71254 0
AL ZAHRAA UNIVERISITY HOSPITAL,AZHAR UNIVERISITY
ABASSIA
,Cairo
,EGYPT
Country 71254 0
Egypt
Phone 71254 0
+201096565703
Fax 71254 0
Email 71254 0
[email protected]
Contact person for public queries
Name 71255 0
Prof taiseer marouf
Address 71255 0
PROFESSOR OB/GYN
AZHAR UNIVERSITY
AL ZAHRA UNIVERISITY HOSPITAL
,CAIRO
,EGYPT
Country 71255 0
Egypt
Phone 71255 0
+201223660078
Fax 71255 0
Email 71255 0
[email protected]
Contact person for scientific queries
Name 71256 0
A/Prof nahed ezzat
Address 71256 0
assistantprofessor OB/GYN
AZHAR UNIVERSITY
AL ZAHRA UNIVERISITY HOSPITAL
CAIRO
,EGYPT
Country 71256 0
Egypt
Phone 71256 0
+20122654789
Fax 71256 0
Email 71256 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23473Study protocol   

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseClinical evaluation of autologous platelet rich plasma injection in postmenopausal vulvovaginal atrophy: A pilot study.2022https://dx.doi.org/10.1111/jocd.14873
N.B. These documents automatically identified may not have been verified by the study sponsor.