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Impact of Urethral Mobility on the Success of Sling Operations

Are Unsatisfying Results After TVT and TOT Operations Associated With Increased Urethral Mobility

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02301013
Enrollment
140
Registered
2014-11-25
Start date
2013-03-31
Completion date
2015-06-30
Last updated
2014-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence

Brief summary

Main objective is to evaluate the relation between the increased urethral mobility and unsuccessful treatment after TVT and TOT operations. 140 patients will be included in the research who are planned to have TVT and TOT operations with SUI and MUI diagnoses.Female patients of 25 to 70 years of age who are positive for stress test will be included. All patients will be questioned for parity, body mass index, menopausal state, medical history, and examined for POP-Q stage, urodynamy, stress test, UDI 6, IIQ7 and with transperineal sonography preoperatively. Passive mobility angle and active mobility angle will be measured. The relationship between passive mobility angle or active mobility angle and success of sling operations will be determined in this study.

Detailed description

Transperineal sonography will be performed in a 300 cc filled bladder state, on a horizon which connects the lower margin of the pubic bone and the lower side of the urethral part of the bladder. First measurement will be done on litotomy position in resting state, second on 45 degrees reverse trandelenburg position in resting state and third one on 45 degrees reverse trandelenburg position in maximal valsalva straining state. The alteration between the angles measured at resting litotomy position and the resting reverse trandelenburg position is named as passive mobility angle (trigger gap) and the angle measured between the trigger gap and maximal valsalva state is named as active mobility angle. Furthermore, post voiding residues have also been measured by transperineal ultrasonography.

Interventions

PROCEDUREUrinary incontience surgery

Surgery for stress or mixed urinary incontience

DRUG300 cc saline

Sponsors

Kanuni Sultan Suleyman Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* 140 patients will be included in the research who are planned to have TVT and TOT operations with SUI and MUI diagnoses between March 1, 2013 and January 1, 2015 in Kanuni Sultan Suleyman Medical Research and Educational Hospital.

Exclusion criteria

* Patients with level 3 or higher level of uterine descensus, previous urinary incontinence surgery, overactive bladder and who are unwilling for randomization will not been included.

Design outcomes

Primary

MeasureTime frameDescription
Subjective Success of Sling Operations6 monthsPatients whose postoperative UDI-6 and IIQ-7 scores lower than 10 will described as success of sling operations

Secondary

MeasureTime frameDescription
Objective Success of Sling Operations6 monthsA patient with a bladder filled 300 cc saline will cough and if no leakage of urine,the patient will be described as ''cured''.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026