In this clinical trial study , 80 patients with urethral stenosis who underwent internal urethrotomy are reviwed & followed in Tehran Shohada hospital from Aban 94 to Shahrivar 96. Inclusion criteria are based on history and physical examination and radiographic & cystoscopic findings available ( in the short < 1.5 cm). People with long stenosis , penile stricture , such as Balanitis Xerotica Obliterance (BXO) and Benign Prostatic Hyperplasia (BPH) will be excluded . Patients wil be selected based on thorough history and physical examination and questionnaire prepared by radiographic studies ( for anterior strictures ). Patients will undergone Star-like internal urethrotomy under anesthesia and under the dorsal lithotomy position. The patients were divided into two groups and submucosal injection of 0.1mg / 2cc mitomycin- C with 22-Gauge needle will be done for half of patients . Postoperative catheter is inserted for five days . Then patients symptoms & uroflowmetry findings after removing the catheter and also 6 months after will be evaluated; if abnormal results (Q-max <15 obstructive pattern ), Retrograde UrethroGram - Voiding CystoUrethroGram (RUG-VCUG) and , if necessary, carry out and patency and the need for internal urethrotomy and dilatation will be reviewed and , if necessary, up to once again undergo incision & re- injection of mitomycin-C .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015092724225N1
Registration date:2017-04-08, 1396/01/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-08, 1396/01/19
Registrant information
Name
Saman Najafi
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2291 2156
Email address
saman.najafi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Infertility and Reproductive Health Research Center Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of locally injected Mitomycin-C after internal urethrotomy in treating urethral stricture.
Public title
Mitomycin effect in the treatment of urethral stenosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
stenosis length <1.5 cm
Exclusion criteria:
Long stricture,
shortness of penile,
such as BXO and BPH
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Infertility and Reproductive Health Research Center Shahid Beheshti University of Medical Sciences
Street address
Taleghani Hospital
City
Tehran
Postal code
Approval date
2015-05-27, 1394/03/06
Ethics committee reference number
400/719
Health conditions studied
1
Description of health condition studied
urthral stenosis
ICD-10 code
N35
ICD-10 code description
Urethral Stricture
Primary outcomes
1
Description
Improving Urine voiding
Timepoint
Immediately after the intervention, and six months after intervention
Method of measurement
Uroflowmetry- RUG-VCUG - Cystoscopy
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group, internal urethrotomy is done for patients with urethral stricture; then 0.1mg/2cc mitomycin-c is injected submucosally with needle 22-gauge in incision sites; and after that urethral catheter is inserted for one week.
Category
Treatment - Drugs
2
Description
In control group, internal urethrotomy is done for patients with urethral stricture; and then urethral catheter is inserted for one week.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada-ye Tajrish Hospital
Full name of responsible person
Dr.Saman Najafi
Street address
Shohada-ye Tajrish Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Infertility and Reproductive Health Research Center
Full name of responsible person
Mrs.Zahra Sadeghzadeh
Street address
Taleghani Hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Infertility and Reproductive Health Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Infertility and Reproductive Health Research Center
Full name of responsible person
Dr.Saman Najafi
Position
Physician/Urology Resident
Other areas of specialty/work
Street address
Infertility and Reproductive Health Research Center
City
Tehran
Postal code
Phone
+98 21 2249 6597
Fax
Email
saman.najafi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Infertility and Reproductive Health Research Center
Full name of responsible person
Dr.Seyyed Jalil Hosseini
Position
Urology subspecialist
Other areas of specialty/work
Street address
Infertility and Reproductive Health Research Center
City
Tehran
Postal code
Phone
+98 21 2240 6597
Fax
Email
jhosseinee@gmai.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saman Najafi
Position
Physician/ Urology Resident
Other areas of specialty/work
Street address
7th Floor, 2nd SBUMS Bldg., Next to Ayatollah Taleghani Hospital, Evin, Tehran, Iran. Post code: 1
City
Tehran
Postal code
Phone
+98 21 2291 2156
Fax
+98 21 2291 2156
Email
saman.najafi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)