Sonographic Evaluation of the Single-incision Needleless (Contasure-needleless®) Mini-sling Placement to Predict Success

NCT ID: NCT03763097

Last Updated: 2019-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-26

Study Completion Date

2019-04-21

Brief Summary

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Transperineal ultrasonography is gaining importance in preoperative and postoperative evaluation of the patient with urinary incontinence with allowing well detailed information about the anterior compartment.

There is little evidence that transperineal sonography can aid surgeons to predict the success or failure after mid-urethral slings.

We aimed to investigate the efficacy of sonography in mini-sling operations to predict the success or failure.

Detailed Description

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Women who are scheduled for anti-incontinence operation due to their stress urinary incontinence will be pre- and postoperatively evaluated by transperineal and introital ultrasound.

Patients will be followed for at least 1 year.

Conditions

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Urinary Incontinence,Stress

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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participants

Patients who are scheduled for single-incision needleless (Contasure-needleless®) mini-sling for their stress urinary incontinence. They will be assessed by Pelvic floor ultrasound

Pelvic floor ultrasound

Intervention Type DIAGNOSTIC_TEST

Pelvic floor ultrasound will include transperineal and introital ultrasound

Interventions

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Pelvic floor ultrasound

Pelvic floor ultrasound will include transperineal and introital ultrasound

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients with clinically stress urinary incontinence
* Patients who claim that their condition severely impair their quality of life
* Patients who are failed on conservative management (life style changes and pelvic floor exercises)

Exclusion Criteria

* Patients who have unregulated diabetes mellitus (they will be included after appropriate and sustainable blood glucose regulation)
* Patients who have neurological condition that may affect the incontinence
* Patients who have psychiatric disease that may affect the subjective evaluation.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bartin State Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Murat Yassa

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Murat Yassa, MD

Role: PRINCIPAL_INVESTIGATOR

Bartin State Hospital

Locations

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Bartin State Hospital

Bartın, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Dogan O, Kaya AE, Pulatoglu C, Basbug A, Yassa M. A randomized comparison of a single-incision needleless (Contasure-needleless(R)) mini-sling versus an inside-out transobturator (Contasure-KIM(R)) mid-urethral sling in women with stress urinary incontinence: 24-month follow-up results. Int Urogynecol J. 2018 Sep;29(9):1387-1395. doi: 10.1007/s00192-018-3624-4. Epub 2018 Mar 16.

Reference Type BACKGROUND
PMID: 29549394 (View on PubMed)

Other Identifiers

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Ba2018-4

Identifier Type: -

Identifier Source: org_study_id

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