Prolapse, VaginalcolpocleisisNCT07071818
Transperineal Ultrasound Evaluation of Vesicourethral Angle and de Novo SUI After Colpocleisis Surgery
A study testing Colpocleisis Group in people with Prolapse, Vaginal, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 years, women only
- Conditions the study is for
- Prolapse, Vaginal
- What is being tested?
- Colpocleisis Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziosmanpaşa Training and Research Hospital
Istanbul
Serkan kumbasar, Assistant Professor, 5067873216, drserkankumbasar@hotmail.com
About this study
Official title: Evaluation of the Vesicourethral Angle by Preoperative and Postoperative Transperineal Ultrasound in Patients Undergoing Colpocleisis Surgery and Assessment of de Novo Urinary Incontinence
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.
Read the 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.
- Conditions
- Prolapse, Vaginal
- Being tested
- Colpocleisis Group
- Keywords
- Colpocleisis, Transperineal Ultrasound, de Novo Incontinence, Vesicourethral Angle
- Medical subject headings
- Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colpocleisis GroupProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Colpocleisis Group | Other | This study has a single intervention cohort consisting of patients undergoing colpocleisis. All participants in this group will receive standard surgical care (colpocleisis), and no additional intervention will be administered as part of the research. The same protocol will be applied to all participants: vesicourethral angle will be measured using transperineal ultrasound before and six months after surgery. There is no comparison group or randomization. Receives: Procedure: Colpocleisis Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Preoperative), 6 Months Postoperative
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.
Measured: 6 Months Postoperative
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.
Measured: Preoperative, 6 Months Postoperative
Change in POP-Q Stage
Assessment of anatomical improvement in pelvic organ prolapse using POP-Q staging system, comparing pre- and postoperative values.
Measured: Preoperative, 6 Months Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Jul 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolapse, VaginalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Serkan Kumbasar, Gaziosmanpasa Research and Education Hospital
- Investigators
- ecenur çelikoğlu, md, Principal investigator, Gaziosmanpaşa training and research hospitalyağmur acıyiyen, md, Principal investigator, Gaziosmanpaşa training and research hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071818
- Sponsor's protocol ID
- gopcolpoultra
- Acronym
- colpocleisis
- Status last verified
- Jul 2025
- First submitted
- 4 Jul 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Vesicourethral Angle by Preoperative and Postoperative Transperineal Ultrasound in Patients Undergoing Colpocleisis Surgery and Assessment of de Novo Urinary Incontinence
- ClinicalTrials.gov ID
- NCT07071818
- Acronym / sponsor ID
- colpocleisis / gopcolpoultra
- Conditions
- Prolapse, Vaginal
- Keywords
- Colpocleisis, Transperineal Ultrasound, de Novo Incontinence, Vesicourethral Angle
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Colpocleisis Group | Other | Procedure: Colpocleisis GroupThis study has a single intervention cohort consisting of patients undergoing colpocleisis. All participants in this group will receive standard surgical care (colpocleisis), and no additional intervention will be administered as part of the research. The same protocol will be applied to all participants: vesicourethral angle will be measured using transperineal ultrasound before and six months after surgery. There is no comparison group or randomization. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colpocleisis GroupParticipants 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. | Procedure or surgery | Colpocleisis Group |
Primary outcome
Change in Vesicourethral Angle Measured by Transperineal Ultrasound
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Preoperative, 6 Months Postoperative
Assessment of anatomical improvement in pelvic organ prolapse using POP-Q staging system, comparing pre- and postoperative values.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ecenur çelikoğlu, md principal investigator
Gaziosmanpaşa training and research hospital
yağmur acıyiyen, md principal investigator
Gaziosmanpaşa training and research hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colpocleisis Group in people with Prolapse, Vaginal, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact serkan kumbasar, md (5067873216, drserkankumbasar@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Vesicourethral Angle Measured by Transperineal Ultrasound (time frame: Baseline (Preoperative), 6 Months Postoperative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.