Stress Urinary IncontinenceNCT06292702
Reducing Early Urinary Disorders After Stress Incontinence Surgery: The Role of Vaginal Wall Tension.
A study testing Traditional Burch colposuspension and Modified Burch colposuspension in people with Stress Urinary Incontinence, run by Damascus University at 1 site in Syria.
Trial summary
The progress in surgical procedures for treating female stress urinary incontinence has led to the development of tension-free techniques such as the trans-obturator tape (TOT). Nonetheless, concerns regarding complications associated with the use of artificial mesh have sparked renewed interest in traditional… Read more about this study
- Who is it for?
- Ages 25 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Traditional Burch colposuspension and Modified Burch colposuspension
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSyria
- Study dates
- 1 Jan 2022to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The female patients with urinary incontinence are visiting the urology clinic due to a history of stress urinary incontinence, with failure of conservative treatment or non-compliance with treatment.
Who cannot join
- Patients refusing study participation.
- Contraindication to general anesthesia.
- Contraindication to laparoscopic surgery.
- Coexisting other type of urinary incontinence with urodynamic disturbance.
- Preoperative post-void residual urine.
- Previous pelvic irradiation.
- Concurrent anatomical deformity associated with genital prolapse, cystocele, or intrinsic sphincteric deficiency ( ISD ).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduce Voiding Dysfunction After Laparoscopic Burch Colposuspension by Using Lateral Tension for the Anterior Vaginal Wall Before Cooper's Ligament Suspension in Stress Incontinence Women. (A Randomized Controlled Clinical Trial).
The progress in surgical procedures for treating female stress urinary incontinence has led to the development of tension-free techniques such as the trans-obturator tape (TOT). Nonetheless, concerns regarding complications associated with the use of artificial mesh have sparked renewed interest in traditional retropubic suspension techniques (Burch). This study introduces a modified technique that creates lateral tension for the anterior vaginal wall before the conventional suspending to the Cooper ligament, limiting the tension on the urethra and reducing the risk of postoperative urinary voiding dysfunction with the same success rates. This technique offers the advantages of a tension-free procedure while still providing the benefits of retropubic suspension. Moreover, this modified technique eliminates the need for artificial mesh, reducing the risk of associated complications. This promising alternative offers effective support for the urethra and reduces postoperative emptying disorders. However, further research and studies are necessary to validate the long-term efficacy and safety of this modified technique.
Read the detailed description
This is a randomized controlled clinical trial that aims to collect a sample within two years from the date of approval of the Scientific Research Council at Damascus University. The study will focus on a group of patients who will undergo a Burch colposuspension procedure, which is a surgical treatment for stress urinary incontinence. The patients will be randomly divided into two groups.
The first group will undergo a traditional Burch colposuspension, which involves lifting the vagina towards the Cooper ligament. The second group will receive a modified Burch colposuspension, which involves applying lateral tension for the anterior vaginal wall before the routine suspension on the Cooper ligament. The patients will then be followed for at least 3 months.
Data will be collected from the patients included in the study before the surgical operation, and then the patients will be followed up for at least three months after the surgery. The data will be compared between the two groups in terms of voiding dysfunction after surgery, which will be assessed according to International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms ICIQ_FLUTS and by assessing uroflowmetry, urinary retention, and post-void residual (PVR) urine.
Additionally, the recovery from stress incontinence will be compared by using The Patient's Global Impression of Improvement (PGI-I) and the stress test.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Traditional Burch colposuspension, Modified Burch colposuspension
- Keywords
- Stress urinary incontinence., Burch colposuspension., Voiding dysfunction., Tension-free vaginal tape., TVT, TOT, TVT-O.
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Burch colposuspensionProcedure or surgery
Peforming two stitches between the anterior vaginal wall and Cooper's ligament.
Modified Burch colposuspensionProcedure or surgery
Performing lateral tension for the anterior vaginal wall towards the intersection point of the arcus tendineus and the lower edge of the pubic bone then performing two stitches between the anterior vaginal wall and Cooper's ligament.
| Study group | Role | What they receive |
|---|---|---|
| Traditional laparoscopic Burch procedure | Experimental | Patients who were randomized to receive classic laparoscopic Burch colposuspension. Receives: Procedure: Traditional Burch colposuspension |
| Modified laparoscopic Burch procedure: | Experimental | Patients who were randomized to receive modified laparoscopic Burch colposuspension by applying lateral tension for the anterior vaginal wall before performing traditional anterior vaginal wall suspension toward Cooper's ligament. Receives: Procedure: Modified Burch colposuspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective voiding dysfunction after surgery, first evaluation
Voiding dysfunction will be assessed by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). It is composed of 12 questions, each question with a score from 0 to 4. Thus, the range of overall scores is from 0 to 16, 12, and 20 for filling, obstructive voiding, and incontinence scales, respectively. The total score range is from 0 to 48 for all types of voiding dysfunction after surgery
Measured: One week after surgery
Urinary peak flow rate after surgery, first evaluation
Urinary peak flow rate will be determined by uroflowmetry, and divided into normal urinary flow rate for any value above or equal to 12 ml/sec, and abnormal urinary flow rate for any value under 12 ml/sec.
Measured: One week after surgery
Residual urine after surgery, first evaluation
Residual urine will be assessed by ultrasound after voiding. All residual urine below 50 ml is considered insignificant and normal, while any residual urine above 50 ml is considered clinically significant and abnormal.
Measured: One week after surgery
Urinary retention after surgery, first evaluation
Urinary retention will be assessed by clinical examination and ultrasound. It refers to the inability to void despite having a full bladder.
Measured: One week after surgery
Subjective voiding dysfunction after surgery, second evaluation
Voiding dysfunction will be assessed by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). It is composed of 12 questions, each question with a score from 0 to 4. Thus, the range of overall scores is from 0 to 16, 12, and 20 for filling, obstructive voiding, and incontinence scales, respectively. The total score range is from 0 to 48 for all types of voiding dysfunction after surgery
Measured: One month after surgery
Urinary peak flow rate after surgery, second evaluation
Urinary peak flow rate will be determined by uroflowmetry, and divided into normal urinary flow rate for any value above or equal to 12 ml/sec, and abnormal urinary flow rate for any value under 12 ml/sec.
Measured: One month after surgery
Residual urine after surgery, second evaluation
Residual urine will be assessed by ultrasound after voiding. All residual urine below 50 ml is considered insignificant and normal, while any residual urine above 50 ml is considered clinically significant and abnormal.
Measured: One month after surgery
Urinary retention after surgery, second evaluation
Urinary retention will be assessed by clinical examination and ultrasound. It refers to the inability to void despite having a full bladder.
Measured: One month after surgery
Subjective voiding dysfunction after surgery, third evaluation
Voiding dysfunction will be assessed by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). It is composed of 12 questions, each question with a score from 0 to 4. Thus, the range of overall scores is from 0 to 16, 12, and 20 for filling, obstructive voiding, and incontinence scales, respectively. The total score range is from 0 to 48 for all types of voiding dysfunction after surgery
Measured: Three months after surgery
Urinary peak flow rate after surgery, third evaluation
Urinary peak flow rate will be determined by uroflowmetry, and divided into normal urinary flow rate for any value above or equal to 12 ml/sec, and abnormal urinary flow rate for any value under 12 ml/sec.
Measured: Three months after surgery
Residual urine after surgery, third evaluation
Residual urine will be assessed by ultrasound after voiding. All residual urine below 50 ml is considered insignificant and normal, while any residual urine above 50 ml is considered clinically significant and abnormal.
Measured: Three months after surgery
Urinary retention after surgery, third evaluation
Urinary retention will be assessed by clinical examination and ultrasound. It refers to the inability to void despite having a full bladder.
Measured: Three months after surgery
Secondary outcomes (6)
Subjective recovery from urinary incontinence, first evaluation
Subjective recovery from urinary incontinence will be assessed by the Patient's Global Impression of Improvement (PGI-I). It is an instrument designed to measure a patient's interpretation of symptom changes following intervention.
The patient enters his answer on a 7-point scale scored as (1) "very much better," to (7) "very much worse."
Measured: one week after surgery
Objective recovery from urinary incontinence, first evaluation
Objective recovery will be assessed by a urinary stress test by filling the bladder and telling the patient to make an effort and cough and repeat it three times.
The negative test is considered an objective recovery
Measured: one week after surgery
Subjective recovery from urinary incontinence, second evaluation
Subjective recovery from urinary incontinence will be assessed by the Patient's Global Impression of Improvement (PGI-I). It is an instrument designed to measure a patient's interpretation of symptom changes following intervention.
The patient enters his answer on a 7-point scale scored as (1) "very much better," to (7) "very much worse."
Measured: One month after surgery
Objective recovery from urinary incontinence, second evaluation
Objective recovery will be assessed by a urinary stress test by filling the bladder and telling the patient to make an effort and cough and repeat it three times.
The negative test is considered an objective recovery
Measured: One month after surgery
Subjective recovery from urinary incontinence, third evaluation
Subjective recovery from urinary incontinence will be assessed by the Patient's Global Impression of Improvement (PGI-I). It is an instrument designed to measure a patient's interpretation of symptom changes following intervention.
The patient enters his answer on a 7-point scale scored as (1) "very much better," to (7) "very much worse."
Measured: three months after surgery
Objective recovery from urinary incontinence, third evaluation
Objective recovery will be assessed by a urinary stress test by filling the bladder and telling the patient to make an effort and cough and repeat it three times.
The negative test is considered an objective recovery
Measured: three months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 Jan 2022
- Primary completion1 Oct 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samir M Enzawi, M.D, Ph.D, Study director, dr.enzsamir58@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292702
- Sponsor's protocol ID
- Modified Burch Colposuspension
- Status last verified
- Feb 2024
- First submitted
- 27 Feb 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Natale F, La Penna C, Saltari M, Piccione E, Cervigni M. Voiding dysfunction after anti-incontinence surgery. Minerva Ginecol. 2009 Apr;61(2):167-72.
PubMed 19255563Steele SS, Bailly GG. Choosing the right sling for your patient. Can Urol Assoc J. 2017 Jun;11(6Suppl2):S132-S134. doi: 10.5489/cuaj.4635.
PubMed 28616112Sassani JC, Artsen AM, Moalli PA, Bradley MS. Temporal Trends of Urogynecologic Mesh Reports to the U.S. Food and Drug Administration. Obstet Gynecol. 2020 May;135(5):1084-1090. doi: 10.1097/AOG.0000000000003805.
PubMed 32282600Karlovsky ME. How to Avoid and Deal with Pelvic Mesh Litigation. Curr Urol Rep. 2016 Aug;17(8):55. doi: 10.1007/s11934-016-0613-3.
PubMed 27287606Barr SA, Thomas A, Potter S, Melick CF, Gavard JA, McLennan MT. Incidence of successful voiding and predictors of early voiding dysfunction after retropubic sling. Int Urogynecol J. 2016 Aug;27(8):1209-14. doi: 10.1007/s00192-016-2972-1. Epub 2016 Feb 19.
PubMed 26894607Valdevenito JP, Mercado-Campero A, Naser M, Castro D, Ledesma M, Arribillaga L. Voiding dynamics in women with urinary incontinence but without voiding symptoms. Neurourol Urodyn. 2020 Nov;39(8):2223-2229. doi: 10.1002/nau.24475. Epub 2020 Aug 7.
PubMed 32767826
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduce Voiding Dysfunction After Laparoscopic Burch Colposuspension by Using Lateral Tension for the Anterior Vaginal Wall Before Cooper's Ligament Suspension in Stress Incontinence Women. (A Randomized Controlled Clinical Trial).
- ClinicalTrials.gov ID
- NCT06292702
- Acronym / sponsor ID
- Modified Burch Colposuspension
- Conditions
- Stress Urinary Incontinence
- Keywords
- Stress urinary incontinence., Burch colposuspension., Voiding dysfunction., Tension-free vaginal tape., TVT, TOT, TVT-O.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The progress in surgical procedures for treating female stress urinary incontinence has led to the development of tension-free techniques such as the trans-obturator tape (TOT). Nonetheless, concerns regarding complications associated with the use of artificial mesh have sparked renewed interest in traditional retropubic suspension techniques (Burch). This study introduces a modified technique that creates lateral tension for the anterior vaginal wall before the conventional suspending to the Cooper ligament, limiting the tension on the urethra and reducing the risk of postoperative urinary voiding dysfunction with the same success rates. This technique offers the advantages of a tension-free procedure while still providing the benefits of retropubic suspension. Moreover, this modified technique eliminates the need for artificial mesh, reducing the risk of associated complications. This promising alternative offers effective support for the urethra and reduces postoperative emptying disorders. However, further research and studies are necessary to validate the long-term efficacy and safety of this modified technique.
Detailed description
This is a randomized controlled clinical trial that aims to collect a sample within two years from the date of approval of the Scientific Research Council at Damascus University. The study will focus on a group of patients who will undergo a Burch colposuspension procedure, which is a surgical treatment for stress urinary incontinence. The patients will be randomly divided into two groups.
The first group will undergo a traditional Burch colposuspension, which involves lifting the vagina towards the Cooper ligament. The second group will receive a modified Burch colposuspension, which involves applying lateral tension for the anterior vaginal wall before the routine suspension on the Cooper ligament. The patients will then be followed for at least 3 months.
Data will be collected from the patients included in the study before the surgical operation, and then the patients will be followed up for at least three months after the surgery. The data will be compared between the two groups in terms of voiding dysfunction after surgery, which will be assessed according to International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms ICIQ_FLUTS and by assessing uroflowmetry, urinary retention, and post-void residual (PVR) urine.
Additionally, the recovery from stress incontinence will be compared by using The Patient's Global Impression of Improvement (PGI-I) and the stress test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional laparoscopic Burch procedure | Experimental | Procedure: Traditional Burch colposuspensionPatients who were randomized to receive classic laparoscopic Burch colposuspension. |
| Modified laparoscopic Burch procedure: | Experimental | Procedure: Modified Burch colposuspensionPatients who were randomized to receive modified laparoscopic Burch colposuspension by applying lateral tension for the anterior vaginal wall before performing traditional anterior vaginal wall suspension toward Cooper's ligament. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The female patients with urinary incontinence are visiting the urology clinic due to a history of stress urinary incontinence, with failure of conservative treatment or non-compliance with treatment.
Key exclusion criteria (7 listed)
- Patients refusing study participation.
- Contraindication to general anesthesia.
- Contraindication to laparoscopic surgery.
- Coexisting other type of urinary incontinence with urodynamic disturbance.
- Preoperative post-void residual urine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Burch colposuspensionPeforming two stitches between the anterior vaginal wall and Cooper's ligament. | Procedure or surgery | Traditional laparoscopic Burch procedure |
| Modified Burch colposuspensionPerforming lateral tension for the anterior vaginal wall towards the intersection point of the arcus tendineus and the lower edge of the pubic bone then performing two stitches between the anterior vaginal wall and Cooper's ligament. | Procedure or surgery | Modified laparoscopic Burch procedure: |
Primary outcome
Subjective voiding dysfunction after surgery, first evaluation
Time frame: One week after surgery
Voiding dysfunction will be assessed by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). It is composed of 12 questions, each question with a score from 0 to 4. Thus, the range of overall scores is from 0 to 16, 12, and 20 for filling, obstructive voiding, and incontinence scales, respectively. The total score range is from 0 to 48 for all types of voiding dysfunction after surgery
Urinary peak flow rate after surgery, first evaluation
Time frame: One week after surgery
Urinary peak flow rate will be determined by uroflowmetry, and divided into normal urinary flow rate for any value above or equal to 12 ml/sec, and abnormal urinary flow rate for any value under 12 ml/sec.
Residual urine after surgery, first evaluation
Time frame: One week after surgery
Residual urine will be assessed by ultrasound after voiding. All residual urine below 50 ml is considered insignificant and normal, while any residual urine above 50 ml is considered clinically significant and abnormal.
Urinary retention after surgery, first evaluation
Time frame: One week after surgery
Urinary retention will be assessed by clinical examination and ultrasound. It refers to the inability to void despite having a full bladder.
Subjective voiding dysfunction after surgery, second evaluation
Time frame: One month after surgery
Voiding dysfunction will be assessed by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). It is composed of 12 questions, each question with a score from 0 to 4. Thus, the range of overall scores is from 0 to 16, 12, and 20 for filling, obstructive voiding, and incontinence scales, respectively. The total score range is from 0 to 48 for all types of voiding dysfunction after surgery
Urinary peak flow rate after surgery, second evaluation
Time frame: One month after surgery
Urinary peak flow rate will be determined by uroflowmetry, and divided into normal urinary flow rate for any value above or equal to 12 ml/sec, and abnormal urinary flow rate for any value under 12 ml/sec.
Residual urine after surgery, second evaluation
Time frame: One month after surgery
Residual urine will be assessed by ultrasound after voiding. All residual urine below 50 ml is considered insignificant and normal, while any residual urine above 50 ml is considered clinically significant and abnormal.
Urinary retention after surgery, second evaluation
Time frame: One month after surgery
Urinary retention will be assessed by clinical examination and ultrasound. It refers to the inability to void despite having a full bladder.
Subjective voiding dysfunction after surgery, third evaluation
Time frame: Three months after surgery
Voiding dysfunction will be assessed by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). It is composed of 12 questions, each question with a score from 0 to 4. Thus, the range of overall scores is from 0 to 16, 12, and 20 for filling, obstructive voiding, and incontinence scales, respectively. The total score range is from 0 to 48 for all types of voiding dysfunction after surgery
Urinary peak flow rate after surgery, third evaluation
Time frame: Three months after surgery
Urinary peak flow rate will be determined by uroflowmetry, and divided into normal urinary flow rate for any value above or equal to 12 ml/sec, and abnormal urinary flow rate for any value under 12 ml/sec.
Residual urine after surgery, third evaluation
Time frame: Three months after surgery
Residual urine will be assessed by ultrasound after voiding. All residual urine below 50 ml is considered insignificant and normal, while any residual urine above 50 ml is considered clinically significant and abnormal.
Urinary retention after surgery, third evaluation
Time frame: Three months after surgery
Urinary retention will be assessed by clinical examination and ultrasound. It refers to the inability to void despite having a full bladder.
6 secondary outcomes
Subjective recovery from urinary incontinence, first evaluation
Time frame: one week after surgery
Objective recovery from urinary incontinence, first evaluation
Time frame: one week after surgery
Subjective recovery from urinary incontinence, second evaluation
Time frame: One month after surgery
Objective recovery from urinary incontinence, second evaluation
Time frame: One month after surgery
Subjective recovery from urinary incontinence, third evaluation
Time frame: three months after surgery
Objective recovery from urinary incontinence, third evaluation
Time frame: three months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Results publication: PubMed 19255563Natale F, La Penna C, Saltari M, Piccione E, Cervigni M. Voiding dysfunction after anti-incontinence surgery. Minerva Ginecol. 2009 Apr;61(2):167-72.
- Results publication: PubMed 28616112Steele SS, Bailly GG. Choosing the right sling for your patient. Can Urol Assoc J. 2017 Jun;11(6Suppl2):S132-S134. doi: 10.5489/cuaj.4635.
- Results publication: PubMed 32282600Sassani JC, Artsen AM, Moalli PA, Bradley MS. Temporal Trends of Urogynecologic Mesh Reports to the U.S. Food and Drug Administration. Obstet Gynecol. 2020 May;135(5):1084-1090. doi: 10.1097/AOG.0000000000003805.
- Results publication: PubMed 27287606Karlovsky ME. How to Avoid and Deal with Pelvic Mesh Litigation. Curr Urol Rep. 2016 Aug;17(8):55. doi: 10.1007/s11934-016-0613-3.
- Results publication: PubMed 26894607Barr SA, Thomas A, Potter S, Melick CF, Gavard JA, McLennan MT. Incidence of successful voiding and predictors of early voiding dysfunction after retropubic sling. Int Urogynecol J. 2016 Aug;27(8):1209-14. doi: 10.1007/s00192-016-2972-1. Epub 2016 Feb 19.
- Results publication: PubMed 32767826Valdevenito JP, Mercado-Campero A, Naser M, Castro D, Ledesma M, Arribillaga L. Voiding dynamics in women with urinary incontinence but without voiding symptoms. Neurourol Urodyn. 2020 Nov;39(8):2223-2229. doi: 10.1002/nau.24475. Epub 2020 Aug 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir M Enzawi, M.D, Ph.D study director
dr.enzsamir58@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Burch colposuspension and Modified Burch colposuspension in people with Stress Urinary Incontinence, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective voiding dysfunction after surgery, first evaluation (time frame: One week after surgery). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06292702, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.