Transperineal Ultrasound Evaluation of Vesicourethral Angle and de Novo SUI After Colpocleisis Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age60-75
SponsorGaziosmanpasa Research and Education Hospital

About this trial

This prospective observational study aims to evaluate changes in the vesicourethral angle using transperineal ultrasound before and after colpocleisis surgery, and to assess the relationship of these changes with the development of de novo stress urinary incontinence.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Colpocleisis Group

    Procedure/Surgery

    Participants will undergo colpocleisis surgery as part of routine clinical care. The study involves transperineal ultrasound (TPUS) to measure the vesicourethral angle preoperatively and postoperatively, along with assessments for de novo stress urinary incontinence, POP-Q staging, PFDI-20 questionnaire, and stress testing.

Treatment groups

31 Participants
are divided into 1 treatment group
Group A: Colpocleisis GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

Change in Vesicourethral Angle Measured by Transperineal Ultrasound

The primary outcome is the change in the vesicourethral angle measured via transperineal ultrasound before and after colpocleisis surgery. The angle will be measured in degrees using standardized TPUS imaging protocols.

Time frame
Baseline (Preoperative), 6 Months Postoperative
2

Incidence of de Novo Stress Urinary Incontinence

The proportion of patients who develop new-onset (de novo) stress urinary incontinence following colpocleisis surgery, as determined by physical examination (stress test) and patient-reported symptoms.

Time frame
6 Months Postoperative
3

Change in PFDI-20 (Pelvic Floor Distress Inventory-20) Score

Evaluation of changes in pelvic floor symptoms and distress based on patient responses to the validated PFDI-20 questionnaire administered before and after surgery.

Time frame
Preoperative, 6 Months Postoperative
4

Change in POP-Q Stage

Assessment of anatomical improvement in pelvic organ prolapse using POP-Q staging system, comparing pre- and postoperative values.

Time frame
Preoperative, 6 Months Postoperative

Secondary outcomes

Other outcomes

Sponsors and contacts

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