NCT01903590

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 13, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 19, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 1, 2014

Status Verified

March 1, 2014

Enrollment Period

1 year

First QC Date

July 13, 2013

Last Update Submit

June 28, 2014

Conditions

Female Urinary Stress Incontinence

Keywords

TVT,TOT,Randomized

Outcome Measures

Primary Outcomes (1)

  • 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''

    One year

Secondary Outcomes (4)

  • Objective effectiveness by cough test at 6 and 12 th months postoperatively

    One year

  • Subjective effectiveness by UDI-6 and IIQ-7 at 6-12 th months postoperatively

    One year

  • Short term and long term surgical complications

    One year

  • The prevalence of voiding dysfunction at 1 and 12 th months postoperatively

    One year

Study Arms (2)

Transvaginal Tape Surgery

ACTIVE COMPARATOR

Randomized 50 patients undergoing TVT

Procedure: TVT surgery TOT surgery

Transobturator tape surgery

EXPERIMENTAL

Randomized 50 patients undergoing TOT

Procedure: TVT surgery TOT surgery

Interventions

TVT surgery TOT surgeryPROCEDURE
Transobturator tape surgeryTransvaginal Tape Surgery

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Zekai Tahir Burak Woman Health Teaching and Research Hospital

Ankara, Cankaya, 06590, Turkey (Türkiye)

Location

Study Officials

  • Sabri Cavkaytar, MD

    Zekai Tahir Burak Women's Health Research and Education Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Obstetrics and Gynecology specialist

Study Record Dates

First Submitted

July 13, 2013

First Posted

July 19, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

July 1, 2014

Record last verified: 2014-03

Locations

TU(1)