Clinical trial NCT03763097: Sonographic Evaluation of the Single-incision Needleless (Contasure-needleless®) Mini-sling Placement to Predict Success
Official title: Sonographic Evaluation of the Single-incision Needleless (Contasure-needleless®) Mini-sling Placement to Predict Success
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence,Stress
Keywords: pelvic floor ultrasonography
transperineal ultrasound
introital ultrasound
mini-sling
needleless
Urinary Incontinence,Stress
Lead sponsor: Bartin State Hospital
Sponsor class: OTHER_GOV
First posted: 2018-12-04
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have stress urinary incontinence and who are scheduled for needleless mini-sling operation.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The correlation of failure with the sonographic features of the mesh
timeFrame: Evaluation at postoperative 1st and 4th weeks
Secondary outcomes:
measure: Nocturia
timeFrame: Evaluation at postoperative 1st and 4th weeks and preoperatively
measure: Urge symptoms
timeFrame: Evaluation at postoperative 1st and 4th weeks and preoperatively
measure: Subjective success
timeFrame: Evaluation at postoperative 1st and 4th weeks
measure: POP-Q
timeFrame: Evaluation at postoperative 1st and 4th weeks and preoperatively
measure: Anterior compartment mobility distances
timeFrame: Evaluation at postoperative 1st and 4th weeks and preoperatively
measure: Anterior compartment mobility angles
timeFrame: Evaluation at postoperative 1st and 4th weeks and preoperatively
Other outcomes:
Locations:
city: Bartin
country: Turkey
facility: Bartin State Hospital
Study officials:
affiliation: Bartin State Hospital
name: Murat Yassa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.