NCT03938844

Brief Summary

Stress urinary incontinence surgery combined with hysterectomy can often be applied to patients in the same session. The aim of this study was to determine which urinary incontinence surgery would be a better option for patients who would have hysterectomy. The aim of this study was to retrospectively review the data of 69 patients between the ages of 2014 and 2017 who underwent total laparoscopic hysterectomy and anti-incontinence surgery (TOT and Burch) for benign indications (uterine pathology) and stress urinary incontinence (SUI). In addition to demographic data and preoperative examination findings, operative times, postoperative hemogram values, postvoiding residual amounts and complications were examined. In addition, FSI test results of women with sexual activity were compared with ICIQ-UI and UDI-6 interrogations related to urinary incontinence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

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

January 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

3 years

First QC Date

May 2, 2019

Last Update Submit

May 3, 2019

Conditions

Incontinence

Keywords

hysterectomyanti-incontinence surgeryBurchTotstress incontinence

Outcome Measures

Primary Outcomes (3)

  • operation time

    The duration of the procedure for stress urinary incontinence surgery was evaluated. recorded in minutes.

    2 years

  • postoperative hemogram values

    postoperative hemogram values were evaluated. Recorded in g / dl.

    2 years

  • postvoiding residues

    postvoiding residues were measured. Recorded in ml.

    2 years

Study Arms (2)

TLH with BURCH Colposuspension

the patients who underwent simultaneous burch copying with TLH was evaluated. In addition to demographic data and preoperative examination findings, operative times, postoperative hemogram values, postvoiding residual amounts and complications were examined. In addition, FSI test results of women with sexual activity were compared with ICIQ-UI and UDI-6 interrogations related to urinary incontinence.

Procedure: BURCH Colposuspension

TLH with Transobturatuar Tape (TOT)

In cases of simultaneous toting with TLH; In addition to demographic data and preoperative examination findings, operative times, postoperative hemogram values, postvoiding residual amounts and complications were examined. In addition, FSI test results of women with sexual activity were compared with ICIQ-UI and UDI-6 interrogations related to urinary incontinence.

Procedure: TOT

Interventions

BURCH ColposuspensionPROCEDURE

stress urinary incontinence surgery ( burch or tot)

TLH with BURCH Colposuspension
TOTPROCEDURE
TLH with Transobturatuar Tape (TOT)

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women between the ages of 40-65 who ; tlh operation with benign reasons and planned, and concurrent stress describing urinary incontinence.

You may qualify if:

  • tlh operation with benign reasons and planned,
  • concurrent stress describing urinary incontinence,
  • Women between the ages of 40-65

You may not qualify if:

  • planned operation with malignant causes,
  • urinary tract infection,
  • medication area for incontinence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 33404, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, M.D, Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

May 2, 2019

First Posted

May 6, 2019

Study Start

January 1, 2014

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

May 7, 2019

Record last verified: 2019-05

Locations

TU(1)