Long Term Follow-UpNCT07730749
Long Term Follow Up Of Transvaginal Cystocele Repair Using Four Armed Collagen Coated Polyester Mesh
An observational study of Long Term Follow-Up and Transvaginal Cystocele Repair, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to assess safety and efficacy of transvaginal repair of cystocele using four armed collagen coated polyester mesh beyond 5 years postoperatively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long Term Follow-Up, Transvaginal Cystocele Repair, Four Armed Collagen
- What is being tested?
- transvaginal cystocele repair
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Jun 2026to 30 Dec 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective cohort study with prospective long-term follow-up will be conducted on 20 patients at Ain Shams University Hospital.
Who may be able to join
- Data of patients who underwent transvaginal cystocele repair using four-armed collagen coated polyester mesh
Who cannot join
- Patients with insufficient postoperative follow-up data.
- Patients with incomplete or missing medical records.
- Patients undergone radiation, laser therapy, or chemotherapy in the pelvic area postoperatively.
- Patients newly discovered uncontrolled diabetes mellitus.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, Cairo Governorate, 11591
Ibrahem M Abdelghany, MBBCH, 00201063256605, IbrahemAbdelghany@med.asu.edu.eg
About this study
Official title: Long Term Follow Up Of Transvaginal Cystocele Repair Using Four Armed Collagen Coated Polyester Mesh; Retrospective Cohort Study With Prospective Long-term Follow-up
This study aims to assess safety and efficacy of transvaginal repair of cystocele using four armed collagen coated polyester mesh beyond 5 years postoperatively.
Read the detailed description
Cystocele, also known as anterior vaginal wall prolapse, is a common condition in females, particularly those with or without uterine prolapse.
Traditionally, cystocele repair has been performed using native tissue suturing techniques. This method involves reinforcing the weakened vaginal wall by plicating and tightening the patient's tissues without introducing any foreign material. While suture repair is associated with fewer foreign body complications, long-term studies have reported notable recurrence rates, leading some surgeons to seek alternative methods.
Mesh insertion involves placing a synthetic material underneath the bladder to reinforce the vaginal wall and improve long-term anatomical outcomes. Although mesh repairs initially showed promising results in reducing recurrence, concerns have arisen regarding complications such as mesh erosion, chronic pelvic pain, and dyspareunia.
- Being tested
- transvaginal cystocele repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transvaginal cystocele repairProcedure or surgery
Patients who undergo transvaginal cystocele repair using four-armed collagen coated polyester mesh.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients who undergo transvaginal cystocele repair using four-armed collagen coated polyester mesh Receives: Procedure: transvaginal cystocele repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term anatomical success rate
Long-term anatomical success rate is defined as the absence of anterior vaginal wall prolapse or the presence of only Stage 0-I cystocele according to Pelvic Organ Prolapse Quantification (POP-Q) classification after 5 years of follow-up postoperatively.
Measured: 5 years of follow-up postoperatively
Secondary outcomes (4)
Functional improvement
Sustained improvement in urinary symptoms will be recorded.
Measured: 5 years of follow-up postoperatively
Sexual function
The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) is a validated, condition-specific questionnaire will be used to evaluate sexual function in women with pelvic floor disorders.
It is a shortened form of the original 31-item PISQ, specifically designed for sexually active women experiencing pelvic organ prolapse (POP) and urinary incontinence (UI).
The questionnaire consists of 12 self-administered questions that assess the impact of pelvic floor health over the past six months. It spans three primary domains:
Behavioral-Emotive Domain (Questions 1-4): Focuses on desire, excitement, frequency, and overall sexual satisfaction.
Physical Domain (Questions 5-9): Evaluates physical symptoms during sex, such as pain, urine leakage, and restrictions due to fear or vaginal bulging.
Partner-Related Domain (Questions 10-12): Addresses the partner's erectile or ejaculatory function as it impacts sexual activity
Measured: 5 years of follow-up postoperatively
Long-term complications
Long-term complications including groin pain, urinary retention, vaginal shortening, infection, mesh erosion or need for mesh removal will be recorded.
Measured: 5 years of follow-up postoperatively
Assesment of quality of life
The Incontinence Impact Questionnaire - Short Form (IIQ-7) will be used to evaluate the quality of life.
It is a condensed version of the original 30-item questionnaire, designed to evaluate life impact over the past month across physical, emotional, and social life areas.
The IIQ-7 consists of 7 self-administered items divided into four clinical domains:
Physical Activity (Items 1 \& 2): Measures impact on household chores and physical recreation like walking or swimming.
Travel (Items 3 \& 4): Evaluates restrictions on entertainment outings and traveling by car or bus more than 30 minutes from home.
Social Relationships (Item 5): Assesses participation in social activities outside the home.
Emotional Health (Items 6 \& 7): Tracks the burden on mental wellbeing, specifically feelings of nervousness, depression, or frustration
Measured: 5 years of follow-up postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start29 Jun 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long Term Follow-UpStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Abdelghany, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730749
- Sponsor's protocol ID
- FMASU MS 473/2026
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow Up Of Transvaginal Cystocele Repair Using Four Armed Collagen Coated Polyester Mesh; Retrospective Cohort Study With Prospective Long-term Follow-up
- ClinicalTrials.gov ID
- NCT07730749
- Acronym / sponsor ID
- FMASU MS 473/2026
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 28 Jul 2026 (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 study aims to assess safety and efficacy of transvaginal repair of cystocele using four armed collagen coated polyester mesh beyond 5 years postoperatively.
Detailed description
Cystocele, also known as anterior vaginal wall prolapse, is a common condition in females, particularly those with or without uterine prolapse.
Traditionally, cystocele repair has been performed using native tissue suturing techniques. This method involves reinforcing the weakened vaginal wall by plicating and tightening the patient's tissues without introducing any foreign material. While suture repair is associated with fewer foreign body complications, long-term studies have reported notable recurrence rates, leading some surgeons to seek alternative methods.
Mesh insertion involves placing a synthetic material underneath the bladder to reinforce the vaginal wall and improve long-term anatomical outcomes. Although mesh repairs initially showed promising results in reducing recurrence, concerns have arisen regarding complications such as mesh erosion, chronic pelvic pain, and dyspareunia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Procedure: transvaginal cystocele repairPatients who undergo transvaginal cystocele repair using four-armed collagen coated polyester mesh |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective cohort study with prospective long-term follow-up will be conducted on 20 patients at Ain Shams University Hospital.
Key inclusion criteria (1 listed)
- Data of patients who underwent transvaginal cystocele repair using four-armed collagen coated polyester mesh
Key exclusion criteria (4 listed)
- Patients with insufficient postoperative follow-up data.
- Patients with incomplete or missing medical records.
- Patients undergone radiation, laser therapy, or chemotherapy in the pelvic area postoperatively.
- Patients newly discovered uncontrolled diabetes mellitus.
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 cystocele repairPatients who undergo transvaginal cystocele repair using four-armed collagen coated polyester mesh. | Procedure or surgery | Study group |
Primary outcome
Long-term anatomical success rate
Time frame: 5 years of follow-up postoperatively
Long-term anatomical success rate is defined as the absence of anterior vaginal wall prolapse or the presence of only Stage 0-I cystocele according to Pelvic Organ Prolapse Quantification (POP-Q) classification after 5 years of follow-up postoperatively.
4 secondary outcomes
Functional improvement
Time frame: 5 years of follow-up postoperatively
Sexual function
Time frame: 5 years of follow-up postoperatively
Long-term complications
Time frame: 5 years of follow-up postoperatively
Assesment of quality of life
Time frame: 5 years of follow-up 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 28 Jul 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long Term Follow-Up and Transvaginal Cystocele Repair, run by Ain Shams University at 1 site in Egypt.
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 4 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 28 Jul 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 Egypt. 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 Ibrahem M Abdelghany, MBBCH (00201063256605, IbrahemAbdelghany@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term anatomical success rate (time frame: 5 years of follow-up postoperatively). 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 28 Jul 2026.