Circumferential Female Urethral DiverticulumNCT07006753
Transvaginal Diverticulum Wall Filling and Coverage Technique for Treating Female Circumferential Urethral Diverticulum
A study testing Transvaginal Diverticulum Wall Filling and Coverage Technique and Conventional surgery in people with Circumferential Female Urethral Diverticulum, run by West China Hospital at 1 site in China.
Trial summary
The goal of this clinical study is to learn if a new surgical technique called transvaginal diverticular wall filling and covering is effective and safe for treating circumferential urethral diverticulum (UD) in female patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Circumferential Female Urethral Diverticulum
- What is being tested?
- Transvaginal Diverticulum Wall Filling and Coverage Technique and Conventional surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 1 Mar 2027
- 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with imaging-confirmed circumferential urethral diverticulum (UD).
- Availability of complete medical records. Minimum of 6 months postoperative follow-up.
Who cannot join
- Presence of uterine prolapse. Diagnosis of vaginitis. Presence of vaginal tumors. Abnormal coagulation function.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sichuan University West China Hospital Department of Urology
Chengdu, Sichuan, 610041
About this study
The goal of this clinical study is to learn if a new surgical technique called transvaginal diverticular wall filling and covering is effective and safe for treating circumferential urethral diverticulum (UD) in female patients. The main questions it aims to answer are:
Does this technique reduce the risk of postoperative complications, such as fistula formation or stress urinary incontinence (SUI)? Does it improve urinary symptoms and sexual function? What are the recurrence rates after surgery using this approach?
Read more
Researchers will follow two groups of patients:
One group includes patients who had this surgery in the past 5 years (retrospective group).
The other group includes patients who are newly treated with this technique and followed prospectively.
Participants will:
Undergo the transvaginal wall filling and covering surgery or conventional surgery.
Have regular follow-up visits to assess symptoms, complications, and quality of life.
Complete questionnaires about urinary and sexual function.
Read the detailed description
Circumferential UD is a rare and complex subtype that surrounds the urethra and is associated with a higher risk of surgical complications when treated with conventional diverticulectomy. To address these challenges, this study utilizes a modified surgical approach in which the demucosalized diverticular wall is preserved, folded, and used to obliterate the diverticular cavity and reinforce the closure of the ostium. This technique aims to reduce surgical trauma, preserve urethral function, minimize dead space, and improve postoperative urinary and sexual function.
All enrolled patients will undergo the transvaginal wall filling and covering surgery or conventional surgery. Follow-up assessments will be conducted at predefined timepoints (1 month and 6 months postoperatively). Evaluations will include physical examinations, symptom assessments, and validated questionnaires addressing urinary symptoms, sexual function, and overall quality of life.
Primary and secondary outcome measures include:
Improvement or resolution of UD-related symptoms (e.g., dysuria, dyspareunia, urgency) Incidence of postoperative complications (e.g., urethrovaginal fistula, de novo stress urinary incontinence) Clinical and imaging-confirmed recurrence Patient-reported outcomes regarding urinary and sexual function
This study aims to provide clinical evidence on the feasibility, safety, and potential advantages of this novel technique for managing circumferential urethral diverticulum in women.
- Being tested
- Transvaginal Diverticulum Wall Filling and Coverage Technique, Conventional surgery
- Keywords
- circumferential female urethral diverticulum, Transvaginal surgery, Recurrence
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal Diverticulum Wall Filling and Coverage TechniqueProcedure or surgery
This surgical intervention is a modified transvaginal technique for the treatment of circumferential female urethral diverticulum (UD). Instead of performing a complete diverticulectomy, the procedure utilizes the patient's own demucosalized diverticular wall to fill the diverticular cavity and reinforce closure of the ostium. The technique aims to preserve the integrity of the dorsal urethra, reduce the risk of fistula, minimize dead space, and improve functional outcomes such as continence and sexual function. This approach is specifically designed for circumferential UD, which poses unique anatomical and surgical challenges.
Conventional surgeryProcedure or surgery
Treat with conventional surgery
| Study group | Role | What they receive |
|---|---|---|
| Transvaginal Diverticulum Wall Filling and Coverage Technique | Experimental | Transvaginal Diverticulum Wall Filling and Coverage Technique for Circumferential UD Receives: Procedure: Transvaginal Diverticulum Wall Filling and Coverage Technique |
| Conventional surgery | Active comparator | Treat with conventional surgery Receives: Procedure: Conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Response Assessment (GRA)
Overall subjective improvement will also be documented using a 5-point Global Response Assessment (GRA) scale:
- = Markedly worse
- = Slightly worse
- = No change
- = Slightly improved
- = Markedly improved
Measured: 6 months postoperatively
Recurrence Rate of Urethral Diverticulum Assessed by Clinical Symptoms
Recurrence will be assessed within 6 months postoperatively based on:
Return of typical urethral diverticulum (UD) symptoms, such as:
Post-void dribbling Dyspareunia Dysuria Recurrent urinary tract infections Palpable anterior vaginal wall mass
Measured: 6 months postoperatively
Urinary Continence Status Assessed by Symptom Type and Stress Test
Urinary continence status will be evaluated at 6 months postoperatively based on:
Patient-reported urinary symptoms, including the presence or absence of:
Stress urinary incontinence (SUI): involuntary leakage of urine during physical effort, sneezing, or coughing
Urgency urinary incontinence (UUI): involuntary leakage accompanied by or immediately preceded by urgency
Objective cough stress test performed in the lithotomy position with a comfortably full bladder
Patients will be classified into one of the following categories:
Continent: No symptoms of SUI or UUI and negative stress test
SUI: Symptomatic stress incontinence or positive stress test
UUI: Symptoms consistent with urgency-related leakage
Mixed urinary incontinence: Presence of both SUI and UUI symptoms
Measured: 6 months postoperatively
Secondary outcomes (1)
Complications
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start1 Jun 2023
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circumferential Female Urethral DiverticulumStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, De-yi Luo, West China Hospital
- Investigators
- Deyi Luo, PhD, Study chair, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006753
- Sponsor's protocol ID
- 2025692
- Status last verified
- Oct 2026
- First submitted
- 22 May 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvaginal Diverticulum Wall Filling and Coverage Technique for Treating Female Circumferential Urethral Diverticulum
- ClinicalTrials.gov ID
- NCT07006753
- Acronym / sponsor ID
- 2025692
- Keywords
- circumferential female urethral diverticulum, Transvaginal surgery, Recurrence
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 5 Jun 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.
The goal of this clinical study is to learn if a new surgical technique called transvaginal diverticular wall filling and covering is effective and safe for treating circumferential urethral diverticulum (UD) in female patients. The main questions it aims to answer are:
Does this technique reduce the risk of postoperative complications, such as fistula formation or stress urinary incontinence (SUI)? Does it improve urinary symptoms and sexual function? What are the recurrence rates after surgery using this approach?
Researchers will follow two groups of patients:
One group includes patients who had this surgery in the past 5 years (retrospective group).
The other group includes patients who are newly treated with this technique and followed prospectively.
Participants will:
Undergo the transvaginal wall filling and covering surgery or conventional surgery.
Have regular follow-up visits to assess symptoms, complications, and quality of life.
Complete questionnaires about urinary and sexual function.
Detailed description
Circumferential UD is a rare and complex subtype that surrounds the urethra and is associated with a higher risk of surgical complications when treated with conventional diverticulectomy. To address these challenges, this study utilizes a modified surgical approach in which the demucosalized diverticular wall is preserved, folded, and used to obliterate the diverticular cavity and reinforce the closure of the ostium. This technique aims to reduce surgical trauma, preserve urethral function, minimize dead space, and improve postoperative urinary and sexual function.
All enrolled patients will undergo the transvaginal wall filling and covering surgery or conventional surgery. Follow-up assessments will be conducted at predefined timepoints (1 month and 6 months postoperatively). Evaluations will include physical examinations, symptom assessments, and validated questionnaires addressing urinary symptoms, sexual function, and overall quality of life.
Primary and secondary outcome measures include:
Improvement or resolution of UD-related symptoms (e.g., dysuria, dyspareunia, urgency) Incidence of postoperative complications (e.g., urethrovaginal fistula, de novo stress urinary incontinence) Clinical and imaging-confirmed recurrence Patient-reported outcomes regarding urinary and sexual function
This study aims to provide clinical evidence on the feasibility, safety, and potential advantages of this novel technique for managing circumferential urethral diverticulum in women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transvaginal Diverticulum Wall Filling and Coverage Technique | Experimental | Procedure: Transvaginal Diverticulum Wall Filling and Coverage TechniqueTransvaginal Diverticulum Wall Filling and Coverage Technique for Circumferential UD |
| Conventional surgery | Active comparator | Procedure: Conventional surgeryTreat with conventional surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female patients with imaging-confirmed circumferential urethral diverticulum (UD).
- Availability of complete medical records. Minimum of 6 months postoperative follow-up.
Key exclusion criteria (1 listed)
- Presence of uterine prolapse. Diagnosis of vaginitis. Presence of vaginal tumors. Abnormal coagulation function.
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 |
|---|---|---|
| Transvaginal Diverticulum Wall Filling and Coverage TechniqueThis surgical intervention is a modified transvaginal technique for the treatment of circumferential female urethral diverticulum (UD). Instead of performing a complete diverticulectomy, the procedure utilizes the patient's own demucosalized diverticular wall to fill the diverticular cavity and reinforce closure of the ostium. The technique aims to preserve the integrity of the dorsal urethra, reduce the risk of fistula, minimize dead space, and improve functional outcomes such as continence and sexual function. This approach is specifically designed for circumferential UD, which poses unique anatomical and surgical challenges. | Procedure or surgery | Transvaginal Diverticulum Wall Filling and Coverage Technique |
| Conventional surgeryTreat with conventional surgery | Procedure or surgery | Conventional surgery |
Primary outcome
Global Response Assessment (GRA)
Time frame: 6 months postoperatively
Overall subjective improvement will also be documented using a 5-point Global Response Assessment (GRA) scale: 1. = Markedly worse 2. = Slightly worse 3. = No change 4. = Slightly improved 5. = Markedly improved
Recurrence Rate of Urethral Diverticulum Assessed by Clinical Symptoms
Time frame: 6 months postoperatively
Recurrence will be assessed within 6 months postoperatively based on: Return of typical urethral diverticulum (UD) symptoms, such as: Post-void dribbling Dyspareunia Dysuria Recurrent urinary tract infections Palpable anterior vaginal wall mass
Urinary Continence Status Assessed by Symptom Type and Stress Test
Time frame: 6 months postoperatively
Urinary continence status will be evaluated at 6 months postoperatively based on: Patient-reported urinary symptoms, including the presence or absence of: Stress urinary incontinence (SUI): involuntary leakage of urine during physical effort, sneezing, or coughing Urgency urinary incontinence (UUI): involuntary leakage accompanied by or immediately preceded by urgency Objective cough stress test performed in the lithotomy position with a comfortably full bladder Patients will be classified into one of the following categories: Continent: No symptoms of SUI or UUI and negative stress test SUI: Symptomatic stress incontinence or positive stress test UUI: Symptoms consistent with urgency-related leakage Mixed urinary incontinence: Presence of both SUI and UUI symptoms
1 secondary outcome
Complications
Time frame: 6 months postoperatively
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 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
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.
Deyi Luo, PhD study chair
West China 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 Transvaginal Diverticulum Wall Filling and Coverage Technique and Conventional surgery in people with Circumferential Female Urethral Diverticulum, run by West China Hospital at 1 site in China.
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 2 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: enrolling by invitation, as of the sponsor's last update on 16 Oct 2026. 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 China. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Response Assessment (GRA) (time frame: 6 months postoperatively). The study lists 3 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 16 Oct 2026.