Female Urinary Stress IncontinenceNCT01903590
TVT Versus TOT in Urinary Stress Incontinence With No Intrinsic Sphincter Deficiency
A study testing TVT surgery TOT surgery in people with Female Urinary Stress Incontinence, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare trans-vaginal tape(TVT) and trans-obturator tape(TOT) procedure in female urinary stress incontinence with no intrinsic sphincter deficiency. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Female Urinary Stress Incontinence
- What is being tested?
- TVT surgery TOT surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2013to Jun 2014
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with urinary stress incontinence with no intrinsic sphincter deficiency
- Women with or without pelvic organ prolapse
Who cannot join
- Previous incontinence surgery
- Urge incontinence or overactive bladder
- Mixed incontinence
- Intrinsic sphincter deficiency
- Body mass index>35
- Un-willing for randomisation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr Zekai Tahir Burak Woman Health Teaching and Research Hospital
Ankara, Cankaya, 06590
About this study
Official title: PROSPECTIVE RANDOMIZED STUDY COMPARING TVT AND TOT IN FEMALE STRESS URINARY INCONTINENCE WITH NO INTRINSIC SPHINCTER DEFICIENCY
The aim of this study is to compare trans-vaginal tape(TVT) and trans-obturator tape(TOT) procedure in female urinary stress incontinence with no intrinsic sphincter deficiency.
Read the detailed description
Patients with isolated stress incontinence attending to Dr Zekai Tahir Burak Woman Health Teaching and Research Hospital Urogynecology Department will be prospectively randomized,by a computer generated randomisation code,to the TVT or TOT. The patients will be aware of the type of the surgical procedure before the operation.
Preoperative evaluation includes clinical history,urinanalysis,pelvic examination QoL assessment and urodynamic study. QoL included Urogenital Distress Inventory Short Form (UDI-6) and the Incontinence Impact Questionnaire Short Form( IIQ-7).Urodynamic study includes cystometry,urethral profilometry and Valsalva leak point pressure (VLPP).In all patients,pelvic floor defect will be evaluated according to the POP quantification (POPQ) staging.To diagnose the occult stress incontinence in patients with pelvic prolapse, a cough test after reducing the prolapse will be performed.Patients will be followed up at 6 and 12 months postoperatively.Objective cure is defined as a negative cough stress test .Negative cough stress test ,but occasional urine leakage during stress will be considered ''improved''.
Postoperative subjective outcomes will be categorized as follows:cured (UDI-6 and IIQ-7 postoperative<10), improved (UDI-6 and IIQ-7 if postoperative>preoperative) and worsened (UDI-6 and IIQ-7 if postoperative<preoperative).
- Conditions
- Female Urinary Stress Incontinence
- Being tested
- TVT surgery TOT surgery
- Keywords
- TVT,TOT,Randomized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TVT surgery TOT surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Transvaginal Tape Surgery | Active comparator | Randomized 50 patients undergoing TVT Receives: Procedure: TVT surgery TOT surgery |
| Transobturator tape surgery | Experimental | Randomized 50 patients undergoing TOT Receives: Procedure: TVT surgery TOT surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the efficiency of TVT and TOT in stress incontinence with no intrinsic deficiency
Postoperative UDI-6 and IIQ-7 <10 and negative cough test will be defined as ''cured''
Measured: One year
Secondary outcomes (4)
Objective effectiveness by cough test at 6 and 12 th months postoperatively
A patient with a bladder filled 300 cc saline will cough and if no leakage of urine,the patient will be described as ''cured''.
Measured: One year
Subjective effectiveness by UDI-6 and IIQ-7 at 6-12 th months postoperatively
Postoperative subjective outcomes will be categorized as follows:cured (UDI-6 and IIQ-7 postoperative<10), improved (UDI-6 and IIQ-7 if postoperative>preoperative) and worsened (UDI-6 and IIQ-7 if postoperative<preoperative).
Measured: One year
Short term and long term surgical complications
Bleeding,bladder and bowel perforation,mesh erosion etc..
Measured: One year
The prevalence of voiding dysfunction at 1 and 12 th months postoperatively
Postoperative residual volume after first voiding >100 cc ,difficulty in voiding will be described as ''voiding dysfunction''.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Urinary Stress 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabri Cavkaytar, Zekai Tahir Burak Women's Health Research and Education Hospital
- Investigators
- Sabri Cavkaytar, MD, Principal investigator, Zekai Tahir Burak Women's Health Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903590
- Sponsor's protocol ID
- ZTB-070713
- Other IDs
- ZekaiTahirBurak-SCavkaytar1
- Status last verified
- Mar 2014
- First submitted
- 13 Jul 2013
- Last updated
- 1 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSPECTIVE RANDOMIZED STUDY COMPARING TVT AND TOT IN FEMALE STRESS URINARY INCONTINENCE WITH NO INTRINSIC SPHINCTER DEFICIENCY
- ClinicalTrials.gov ID
- NCT01903590
- Acronym / sponsor ID
- ZTB-070713
- Conditions
- Female Urinary Stress Incontinence
- Keywords
- TVT,TOT,Randomized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 19 Jul 2013 (estimated)
- 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 aim of this study is to compare trans-vaginal tape(TVT) and trans-obturator tape(TOT) procedure in female urinary stress incontinence with no intrinsic sphincter deficiency.
Detailed description
Patients with isolated stress incontinence attending to Dr Zekai Tahir Burak Woman Health Teaching and Research Hospital Urogynecology Department will be prospectively randomized,by a computer generated randomisation code,to the TVT or TOT. The patients will be aware of the type of the surgical procedure before the operation.
Preoperative evaluation includes clinical history,urinanalysis,pelvic examination QoL assessment and urodynamic study. QoL included Urogenital Distress Inventory Short Form (UDI-6) and the Incontinence Impact Questionnaire Short Form( IIQ-7).Urodynamic study includes cystometry,urethral profilometry and Valsalva leak point pressure (VLPP).In all patients,pelvic floor defect will be evaluated according to the POP quantification (POPQ) staging.To diagnose the occult stress incontinence in patients with pelvic prolapse, a cough test after reducing the prolapse will be performed.Patients will be followed up at 6 and 12 months postoperatively.Objective cure is defined as a negative cough stress test .Negative cough stress test ,but occasional urine leakage during stress will be considered ''improved''.
Postoperative subjective outcomes will be categorized as follows:cured (UDI-6 and IIQ-7 postoperative<10), improved (UDI-6 and IIQ-7 if postoperative>preoperative) and worsened (UDI-6 and IIQ-7 if postoperative<preoperative).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transvaginal Tape Surgery | Active comparator | Procedure: TVT surgery TOT surgeryRandomized 50 patients undergoing TVT |
| Transobturator tape surgery | Experimental | Procedure: TVT surgery TOT surgeryRandomized 50 patients undergoing TOT |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women with urinary stress incontinence with no intrinsic sphincter deficiency
- Women with or without pelvic organ prolapse
Key exclusion criteria (6 listed)
- Previous incontinence surgery
- Urge incontinence or overactive bladder
- Mixed incontinence
- Intrinsic sphincter deficiency
- Body mass index>35
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 |
|---|---|---|
| TVT surgery TOT surgery | Procedure or surgery | Transobturator tape surgery, Transvaginal Tape Surgery |
Primary outcome
Comparison of the efficiency of TVT and TOT in stress incontinence with no intrinsic deficiency
Time frame: One year
Postoperative UDI-6 and IIQ-7 <10 and negative cough test will be defined as ''cured''
4 secondary outcomes
Objective effectiveness by cough test at 6 and 12 th months postoperatively
Time frame: One year
Subjective effectiveness by UDI-6 and IIQ-7 at 6-12 th months postoperatively
Time frame: One year
Short term and long term surgical complications
Time frame: One year
The prevalence of voiding dysfunction at 1 and 12 th months postoperatively
Time frame: One year
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 1 Jul 2014.
Related trials for Female Urinary Stress Incontinence
RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
RecruitingPhase 2
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
Urinary Urge Incontinence, Stress Urinary Incontinence
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.
Sabri Cavkaytar, MD principal investigator
Zekai Tahir Burak Women's Health Research and Education Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TVT surgery TOT surgery in people with Female Urinary Stress Incontinence, run by Zekai Tahir Burak Women's Health 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 2 inclusion and 6 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 1 Jul 2014. 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?
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?
Comparison of the efficiency of TVT and TOT in stress incontinence with no intrinsic deficiency (time frame: One year). 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 1 Jul 2014.