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Completed

NCT Number: NCT01903590

TVT Versus TOT in Urinary Stress 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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dr Zekai Tahir Burak Woman Health Teaching and Research Hospital

Ankara, Cankaya, 06590, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TVT surgery TOT surgery

Procedure

Primary outcomes

  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 outcomes

  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''.

Sponsors and collaborators

Lead sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Other

Registry information

Official study title

PROSPECTIVE RANDOMIZED STUDY COMPARING TVT AND TOT IN FEMALE STRESS URINARY INCONTINENCE WITH NO INTRINSIC SPHINCTER DEFICIENCY

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 19, 2013
Registry last updated
Jul 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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