Incontinence StressNCT06801938
Evaluation of Perioperative Cystoscopy and Methylene Blue Test in Detecting Complications in TVT and TOT Procedures
A study testing Perioperative Cystoscopy and Methylene Blue Test in people with Incontinence Stress, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Comparison of complications detected by perioperative cystoscopy combined with methylene blue test and postoperative cystoscopy in TVT and TOT operations. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Incontinence Stress
- What is being tested?
- Perioperative Cystoscopy and Methylene Blue Test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Providing consent to participate in the study
- Being between the ages of 18 and 85
- Having stress urinary incontinence
- No active cardiac disease
- No connective tissue disorders (e.g., Marfan syndrome)
- No known gynecological malignancy
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- BMI under 30
- No chronic constipation
- No inflammatory bowel disease
Who cannot join
- Not providing consent to participate in the study
- Being under 18 or over 85 years old
- Not having stress urinary incontinence
- Having active cardiac disease
- Having connective tissue disorders (e.g., Marfan syndrome)
- Having a known gynecological malignancy
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- Having a BMI over 30
- Having chronic constipation
- Having inflammatory bowel disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziosmanpaşa Training and Research Hospital
Istanbul, 34
Fatma Ketenci Gencer, associate professor, +905416116469, fathma_k@hotmail.com
Havva Betül Bacak, Specialist, +905333610088, hbbacak90@gmail.com
About this study
Official title: Comparison of Complications Detected by Perioperative Cystoscopy Combined With Methylene Blue Test and Postoperative Cystoscopy in TVT and TOT Operations
Comparison of complications detected by perioperative cystoscopy combined with methylene blue test and postoperative cystoscopy in TVT and TOT operations.
- Conditions
- Incontinence Stress
- Being tested
- Perioperative Cystoscopy and Methylene Blue Test
- Keywords
- tvt, tot, cystoscopy
- 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.
Perioperative Cystoscopy and Methylene Blue TestProcedure or surgery
Also called postoperative cystoscopy
The ability of perioperative methylene blue and cystoscopy versus postoperative cystoscopy to detect complications will be compared in patients.
| Study group | Role | What they receive |
|---|---|---|
| Perioperative Methylene Blue and Cystoscopy with Postoperative Cystoscopy for Complication Detection | Experimental | This arm includes patients with stress urinary incontinence who will undergo perioperative methylene blue test and cystoscopy, followed by postoperative cystoscopy to detect any complications. The aim is to assess the ability of these methods to identify complications in the postoperative period. Receives: Procedure: Perioperative Cystoscopy and Methylene Blue Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of complication detection
Specifically, it would compare the ability of the perioperative methylene blue test and cystoscopy versus postoperative cystoscopy to detect complications. This measure will be used to evaluate the accuracy and effectiveness of both methods
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start1 Jan 2025
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incontinence StressStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- The ability of perioperative methylene blue test and postoperative cystoscopy to detect complications in patients with stress urinary incontinence will be compared.
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801938
- Sponsor's protocol ID
- GaziosmanpasaTREHfkgfkg
- Status last verified
- Jan 2025
- First submitted
- 25 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Complications Detected by Perioperative Cystoscopy Combined With Methylene Blue Test and Postoperative Cystoscopy in TVT and TOT Operations
- ClinicalTrials.gov ID
- NCT06801938
- Acronym / sponsor ID
- GaziosmanpasaTREHfkgfkg
- Conditions
- Incontinence Stress
- Keywords
- tvt, tot, cystoscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 30 Jan 2025 (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.
Comparison of complications detected by perioperative cystoscopy combined with methylene blue test and postoperative cystoscopy in TVT and TOT operations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The ability of perioperative methylene blue test and postoperative cystoscopy to detect complications in patients with stress urinary incontinence will be compared.
| Arm | Type | Receives |
|---|---|---|
| Perioperative Methylene Blue and Cystoscopy with Postoperative Cystoscopy for Complication Detection | Experimental | Procedure: Perioperative Cystoscopy and Methylene Blue TestThis arm includes patients with stress urinary incontinence who will undergo perioperative methylene blue test and cystoscopy, followed by postoperative cystoscopy to detect any complications. The aim is to assess the ability of these methods to identify complications in the postoperative period. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Providing consent to participate in the study
- Being between the ages of 18 and 85
- Having stress urinary incontinence
- No active cardiac disease
- No connective tissue disorders (e.g., Marfan syndrome)
Key exclusion criteria (9 listed)
- Not providing consent to participate in the study
- Being under 18 or over 85 years old
- Not having stress urinary incontinence
- Having active cardiac disease
- Having connective tissue disorders (e.g., Marfan syndrome)
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 |
|---|---|---|
| Perioperative Cystoscopy and Methylene Blue TestAlso: postoperative cystoscopyThe ability of perioperative methylene blue and cystoscopy versus postoperative cystoscopy to detect complications will be compared in patients. | Procedure or surgery | Perioperative Methylene Blue and Cystoscopy with Postoperative Cystoscopy for Complication Detection |
Primary outcome
rate of complication detection
Time frame: 6 months
Specifically, it would compare the ability of the perioperative methylene blue test and cystoscopy versus postoperative cystoscopy to detect complications. This measure will be used to evaluate the accuracy and effectiveness of both methods
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perioperative Cystoscopy and Methylene Blue Test in people with Incontinence Stress, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
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 9 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 6 Feb 2025. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma Ketenci Gencer, Associate Professor (+905416116469, fathma_k@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of complication detection (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2025.