Prolapse, Vaginal
Conditions
Keywords
Colpocleisis, Transperineal Ultrasound, de Novo Incontinence, Vesicourethral Angle
Brief summary
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.
Detailed description
Colpocleisis is a surgical method used for treating pelvic organ prolapse (POP) in elderly women who are no longer sexually active. POP may mask stress urinary incontinence (SUI) by affecting urethral support. After colpocleisis, correction of the prolapse may alter the vesicourethral angle, potentially leading to de novo urinary incontinence. This prospective observational study aims to evaluate changes in the vesicourethral angle using transperineal ultrasound (TPUS) before and after colpocleisis surgery, and to investigate its association with new-onset urinary incontinence. Assessments will be conducted at three time points: Preoperative Visit: Clinical evaluation, POP-Q measurements, PFDI-20 questionnaire, stress test, and TPUS measurement of the vesicourethral angle. Postoperative 1st Month: General recovery and healing assessment. Postoperative 6th Month: Repeat POP-Q, PFDI-20, stress test, TPUS, and evaluation for de novo SUI. The study aims to explore the role of TPUS in identifying anatomical changes that may contribute to urinary symptoms following colpocleisis.
Interventions
PROCEDUREColpocleisis Group
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.
Sponsors
Gaziosmanpasa Research and Education Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, observational cohort study designed to evaluate anatomical and functional changes in patients undergoing colpocleisis surgery. Patients will be followed at predefined intervals (preoperative, 1 month, and 6 months postoperatively) to assess changes in the vesicourethral angle using transperineal ultrasound, and to determine the incidence of de novo stress urinary incontinence. The same cohort of patients will be observed over time without any randomization or intervention beyond standard surgical care.
Eligibility
Sex/Gender
FEMALE
Age
60 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Postmenopausal women with stage 3 or 4 pelvic organ prolapse (according to POP-Q score), who are not sexually active and do not desire future vaginal intercourse, and who consent to undergo colpocleisis surgery will be included in the study.
Exclusion criteria
Those with a history of stress incontinence surgery Those who underwent an additional vesicourethral intervention in addition to colpocleisis surgery Those who wanted sexual intercourse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vesicourethral Angle Measured by Transperineal Ultrasound | Baseline (Preoperative), 6 Months Postoperative | 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. |
| Incidence of de Novo Stress Urinary Incontinence | 6 Months Postoperative | 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. |
| Change in PFDI-20 (Pelvic Floor Distress Inventory-20) Score | Preoperative, 6 Months Postoperative | Evaluation of changes in pelvic floor symptoms and distress based on patient responses to the validated PFDI-20 questionnaire administered before and after surgery. |
| Change in POP-Q Stage | Preoperative, 6 Months Postoperative | Assessment of anatomical improvement in pelvic organ prolapse using POP-Q staging system, comparing pre- and postoperative values. |
Countries
Turkey (Türkiye)
Contacts
Primary Contactserkan kumbasar, md
Outcome results
None listed