The purpose of this study was to evaluate the results of urethoplasty surgery using vaginal wall flap in the treatment of ureteral urethral stenosis in women.
Determining the frequency of symptom recurrence - fistul formation - urinary incontinency -Recurrence of stenosis - Normal urination and reduction of pvr in urethoplasty using vaginal flap in the treatment of urethral stricture
Design
The study is performed on 10-15 patients with urethra stricture because there are no other methods for performing this type of surgery in Iran. It is not possible to compare this.
Settings and conduct
Patients with urethral stenosis referring to Imam Reza Hospital in Tabriz in the years 1396-97 (first 97 months), . -patients undergo uretheroplasty surgery using vaginal flap.Patients will receive follow up 3-6 months later, then they will be provided with Eurodynamic . Concerning removal and reduction of obstructive urethral symptoms according to the AUA Symptom Score questionnaire, reduction of PVR and QMAX recovery, as well as recurrence of symptoms and complications to be evaluated
Participants/Inclusion and exclusion criteria
Entry: Female patients with urinary tract stenosis aged over 18 years who did not respond to canservative, drugs, and dilatation, or did not have an informed consent to do the above measures and had an excess of pvr of 100
Exit: skin problems such as lichen planus or immunosuppression, or virgin subjects or not the informed consent of the above surgery , neurogenic bladder disorders in the urorodynamic
Intervention groups
10 to 15 patients with urethral stricture undergo uretheroplasty surgery using vaginal flap.
Urology Department, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7328
Email address
ebrahimis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the surgical result of urethroplasty by vaginal wall flap in female urethral stricture in a pilot study
Public title
Evaluation of the surgical result of urethroplasty by vaginal wall flap in female urethral stricture in a pilot study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with urinary tract stricture aged over 18 years who had stricure of the urethra and did not respond to conservative, drug and dilatation treatments, or did not have an informed consent to the above measures, and had a higher than 100 cc pvr , if satisfied with orthoplasty Using the vaginal flap
Exclusion criteria:
Patients with skin problems such as Lichen planus or Immunosupercise, or virginal patients, not the deliberate consent of the above surgery [after the describtion], or those who have had neurogenic bladder in the eurorodynamics , are excluded from the action list.
Age
From 18 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Attar Neyshabouri Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
+41 33347054
Approval date
2018-04-30, 1397/02/10
Ethics committee reference number
IR.TBZMED.REC.1397.110
Health conditions studied
1
Description of health condition studied
female urethral stricture
ICD-10 code
N35.8
ICD-10 code description
Other urethral stricture
Primary outcomes
1
Description
females urethral stricture
Timepoint
3 to 12 months after intervention
Method of measurement
Eurodynamic- questionnaire
Secondary outcomes
1
Description
normal voiding
Timepoint
3-12 months after intervention
Method of measurement
questionnaire
2
Description
Recurrence of symptoms
Timepoint
3-12 months after intervention
Method of measurement
questionnaire
3
Description
Create fistulas
Timepoint
3-12 months after intervention
Method of measurement
questionnaire and cystoscopy
4
Description
create Incontinence
Timepoint
3-12 months after intervention
Method of measurement
questionnaire
5
Description
Recurrence of stricture
Timepoint
3-12 months after intervention
Method of measurement
With Eurodynamics and Cystoscopy
Intervention groups
1
Description
Intervention group: Patients with urinary tract stenosis aged over 18 years who indicated stenosis treatment of the urinary tract and had no proper reaction to coservative, drug and dilatation therapies, or an unreliable uncertainty in the conduct of the abovementioned measures, and pvr was more than 100 they were prepared for orthoplasty using vaginal flaps.Patients are placed in the dorsal position of the lithotomy and foley catheter was inserted into the urinary bladder. the anterior wall of the vaginal two parallel incisions on the two sides of the meatus to the proximal maximal of 4 cm {depending on the length of the stenosis} are given and a 1.8 to 2 cm of the vaginal wall flap is dissected. Then the distal part of the flap is fluttered to the proximal flap and the inner part of the flap is tubularized over bigger size of foley catheter[20fr] with absorbable vicryle. The second layer of folded vaginal wall is sutured to native vagina with 3-0 vicryl.Then the foley catheter is removed after 2 weeks.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam reza hospital
Full name of responsible person
Prof. Sakineh Hajebrahimi
Street address
Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
+98 41 3335 7328
Phone
+98 41 3335 7328
Fax
Email
hajebrahimis@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Hasan Soleimanpour
Street address
Deputy of Research and Technology, Central Building of Number Two, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Email
hajebrahimis@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
90
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Hamed Marofi
Position
Resident of Urology
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Urology department, Educational and treatment center of Imam Reza, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
51666-14756
Phone
+98 41 3335 7328
Fax
+98 41 3335 2073
Email
hamedmarofi5@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Prof. Sakineh Hajebrahimi
Position
Professor of Urology- Fellowship in Female Urology
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Department of Urology,Imam Reza educational and treatment center, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
04151666-14756
Phone
+98 984133357328
Email
hajebrahimis@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Hamed Marofi
Position
Resident of Urology
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Urology department, Educational and treatment center of Imam Reza, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
04151666-14756
Phone
+98 984133357328
Fax
+98 41 3335 2073
Email
hamedmarofi5@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Through publication as an article
When the data will become available and for how long
Through publication as an article
To whom data/document is available
Through publication as an article
Under which criteria data/document could be used
Through publication as an article
From where data/document is obtainable
Through publication as an article
What processes are involved for a request to access data/document