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

Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01903590

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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 :

Jun 1, 2013

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Comparison of the efficiency of TVT and TOT in stress incontinence with no intrinsic deficiency [One year]
Postoperative UDI-6 and IIQ-7 <10 and negative cough test will be defined as ''cured''

Secondary Outcome Measures

Objective effectiveness by cough test at 6 and 12 th months postoperatively [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''.
Subjective effectiveness by UDI-6 and IIQ-7 at 6-12 th months postoperatively [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).
Short term and long term surgical complications [One year]
Bleeding,bladder and bowel perforation,mesh erosion etc..
The prevalence of voiding dysfunction at 1 and 12 th months postoperatively [One year]
Postoperative residual volume after first voiding >100 cc ,difficulty in voiding will be described as ''voiding dysfunction''.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Principal Investigator: Sabri Cavkaytar, MD, Zekai Tahir Burak Women's Health Research and Education Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sabri Cavkaytar, Obstetrics and Gynecology specialist, Zekai Tahir Burak Women's Health Research and Education Hospital

ClinicalTrials.gov Identifier:

NCT01903590

Other Study ID Numbers:

ZTB-070713
ZekaiTahirBurak-SCavkaytar1

First Posted:

Jul 19, 2013

Last Update Posted:

Jul 1, 2014

Last Verified:

Mar 1, 2014

Keywords provided by Sabri Cavkaytar, Obstetrics and Gynecology specialist, Zekai Tahir Burak Women's Health Research and Education Hospital

TVT,TOT,Randomized

Additional relevant MeSH terms:

Urinary Incontinence, Stress

Study Results

No Results Posted as of Jul 1, 2014