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TVT Versus TOT in Urinary Stress Incontinence With No Intrinsic Sphincter Deficiency

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ClinicalTrials.gov Identifier: NCT01903590
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : July 1, 2014
Sponsor:
Information provided by (Responsible Party):
Sabri Cavkaytar, Zekai Tahir Burak Women's Health Research and Education Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Female Urinary Stress Incontinence Procedure: TVT surgery TOT surgery Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PROSPECTIVE RANDOMIZED STUDY COMPARING TVT AND TOT IN FEMALE STRESS URINARY INCONTINENCE WITH NO INTRINSIC SPHINCTER DEFICIENCY
Study Start Date : June 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Transvaginal Tape Surgery
Randomized 50 patients undergoing TVT
Procedure: TVT surgery TOT surgery
Experimental: Transobturator tape surgery
Randomized 50 patients undergoing TOT
Procedure: TVT surgery TOT surgery



Primary Outcome Measures :
  1. 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''


Secondary Outcome Measures :
  1. Objective effectiveness by cough test at 6 and 12 th months postoperatively [ Time Frame: One year ]
    A patient with a bladder filled 300 cc saline will cough and if no leakage of urine,the patient will be described as ''cured''.

  2. Subjective effectiveness by UDI-6 and IIQ-7 at 6-12 th months postoperatively [ Time Frame: One year ]
    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).

  3. Short term and long term surgical complications [ Time Frame: One year ]
    Bleeding,bladder and bowel perforation,mesh erosion etc..

  4. The prevalence of voiding dysfunction at 1 and 12 th months postoperatively [ Time Frame: One year ]
    Postoperative residual volume after first voiding >100 cc ,difficulty in voiding will be described as ''voiding dysfunction''.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with urinary stress incontinence with no intrinsic sphincter deficiency
  • Women with or without pelvic organ prolapse

Exclusion Criteria:

  • Previous incontinence surgery
  • Urge incontinence or overactive bladder
  • Mixed incontinence
  • Intrinsic sphincter deficiency
  • Body mass index>35
  • Un-willing for randomisation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903590


Locations
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Turkey
Dr Zekai Tahir Burak Woman Health Teaching and Research Hospital
Ankara, Cankaya, Turkey, 06590
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
Investigators
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Principal Investigator: Sabri Cavkaytar, MD Zekai Tahir Burak Women's Health Research and Education Hospital

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Responsible Party: Sabri Cavkaytar, Obstetrics and Gynecology specialist, Zekai Tahir Burak Women's Health Research and Education Hospital
ClinicalTrials.gov Identifier: NCT01903590     History of Changes
Other Study ID Numbers: ZTB-070713
ZekaiTahirBurak-SCavkaytar1 ( Registry Identifier: ZekaiTahirBurak )
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: July 1, 2014
Last Verified: March 2014

Keywords provided by Sabri Cavkaytar, Zekai Tahir Burak Women's Health Research and Education Hospital:
TVT,TOT,Randomized

Additional relevant MeSH terms:
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Urinary Incontinence, Stress
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms