CystocelecystoselNCT06410469
A Novel Suturing Technique of Cystocele Treatment
An observational study of Cystocele, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The rug weaving-like plication technique may offer a viable alternative for cystocele repair without mesh, utilizing natural tissue. Read more about this study
- Who is it for?
- Ages 40 to 90 years, women only
- Conditions the study is for
- Cystocele
- What is being tested?
- rug weaving-like plication technique
- Type of treatment
- Surgery or procedure
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 15 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 90 years
- Women only
- Adult, Older adult
Study population: Women operated on for anterior wall prolapse in POP-Q
Inclusion Criteria: Patients operated on using the rug weaving plication technique
Exclusion Criteria:Patients operated on using the conventional anterior colporrhaphy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Suturing Technique for Natural Tissue Repair in Cystocele Treatment
The rug weaving-like plication technique may offer a viable alternative for cystocele repair without mesh, utilizing natural tissue.
Read the detailed description
The aim of this study is to compare patients who underwent cystocele repair using the rug weaving plication technique, a natural tissue repair method implemented since 2022 for anterior prolapse, with those treated using conventional techniques.
The investigators retrospectively reviewed 33 patients who underwent anterior vaginal wall repair with the rug weaving-like plication technique and 32 patients who underwent surgery using conventional colporrhaphy. The investigators recorded demographic data and operative details of the patients. At the 6-month postoperative follow-up,the investigators assessed patients' complaints, Pelvic Organ Prolapse Quantification (POP-Q), Modified Oxford Scoring (MOS), and pelvic floor muscle strength. The investigators measured bladder wall thickness between the bladder and anterior vaginal wall using Transvaginal Ultrasonography (USG) and compared demographic data, operative details, and postoperative outcomes between the two groups.
- Conditions
- Cystocele
- Being tested
- rug weaving-like plication technique
- Keywords
- anterior colporraphy, naturel tissue, suture technique
- Medical subject headings
- Cystocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rug weaving-like plication techniqueProcedure or surgery
anterior vaginal wall repair with the rug weaving-like plication technique in cystosel
| Study group | Role | What they receive |
|---|---|---|
| 33 patients operated with rug wave | Group1 Receives: Procedure: rug weaving-like plication technique | |
| 32 patients who underwent surgery using conventional colporrhaphy. | Group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Organ Prolapse Quantification (POP-Q)
Postoperative anterior wall POP-Q
Measurements were conducted with a scaled abeslang while the patient was in the lithotomy position. Evaluation of the anterior compartment involved measuring points Aa and Ba, the apical compartment involved points C and D, and the posterior compartment involved points Ap and Bp. Staging was determined based on the lowest point of prolapse. Stage 0 indicated normal pelvic floor support, Stage 2 indicated a distance between -1 and 1 from the hymen, and Stage 4 indicated total uterine prolapse (prosidentia). Stages 1,2 and 3 indicated intermediary levels of prolapse severity, counting for grades between Stage 0 and 4.
Measured: Maximum 6 months
Secondary outcomes (1)
Bladder thickness
Postoperative bladder thickness:Bladder wall thickness between the bladder and anterior vaginal wall was measured using transvaginal ultrasonography and recorded in millimeters
Measured: Maximum 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start1 Jun 2023
- Primary completion1 Aug 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CystoceleStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahime Bedir Fındık, Ankara City Hospital Bilkent
- Investigators
- Rahime Bedir Findik, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410469
- Sponsor's protocol ID
- AnkaraCHBilkent-MH-RBF-04
- Acronym
- cystosel
- Status last verified
- May 2024
- First submitted
- 3 May 2024
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Findik RB, Doganay M, Aksakal OS, Coskun ZY, Karakaya J. A novel suturing technique for natural tissue repair in cystocele treatment. BMC Womens Health. 2024 Aug 29;24(1):474. doi: 10.1186/s12905-024-03317-3.
PubMed 39210362
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Suturing Technique for Natural Tissue Repair in Cystocele Treatment
- ClinicalTrials.gov ID
- NCT06410469
- Acronym / sponsor ID
- cystosel / AnkaraCHBilkent-MH-RBF-04
- Conditions
- Cystocele
- Keywords
- anterior colporraphy, naturel tissue, suture technique
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 13 May 2024 (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 rug weaving-like plication technique may offer a viable alternative for cystocele repair without mesh, utilizing natural tissue.
Detailed description
The aim of this study is to compare patients who underwent cystocele repair using the rug weaving plication technique, a natural tissue repair method implemented since 2022 for anterior prolapse, with those treated using conventional techniques.
The investigators retrospectively reviewed 33 patients who underwent anterior vaginal wall repair with the rug weaving-like plication technique and 32 patients who underwent surgery using conventional colporrhaphy. The investigators recorded demographic data and operative details of the patients. At the 6-month postoperative follow-up,the investigators assessed patients' complaints, Pelvic Organ Prolapse Quantification (POP-Q), Modified Oxford Scoring (MOS), and pelvic floor muscle strength. The investigators measured bladder wall thickness between the bladder and anterior vaginal wall using Transvaginal Ultrasonography (USG) and compared demographic data, operative details, and postoperative outcomes between the two groups.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 33 patients operated with rug wave | – | Procedure: rug weaving-like plication techniqueGroup1 |
| 32 patients who underwent surgery using conventional colporrhaphy. | – | –Group 2 |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women operated on for anterior wall prolapse in POP-Q
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 |
|---|---|---|
| rug weaving-like plication techniqueanterior vaginal wall repair with the rug weaving-like plication technique in cystosel | Procedure or surgery | 33 patients operated with rug wave |
Primary outcome
Pelvic Organ Prolapse Quantification (POP-Q)
Time frame: Maximum 6 months
Postoperative anterior wall POP-Q Measurements were conducted with a scaled abeslang while the patient was in the lithotomy position. Evaluation of the anterior compartment involved measuring points Aa and Ba, the apical compartment involved points C and D, and the posterior compartment involved points Ap and Bp. Staging was determined based on the lowest point of prolapse. Stage 0 indicated normal pelvic floor support, Stage 2 indicated a distance between -1 and 1 from the hymen, and Stage 4 indicated total uterine prolapse (prosidentia). Stages 1,2 and 3 indicated intermediary levels of prolapse severity, counting for grades between Stage 0 and 4.
1 secondary outcome
Bladder thickness
Time frame: Maximum 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Derived from this study: PubMed 39210362Findik RB, Doganay M, Aksakal OS, Coskun ZY, Karakaya J. A novel suturing technique for natural tissue repair in cystocele treatment. BMC Womens Health. 2024 Aug 29;24(1):474. doi: 10.1186/s12905-024-03317-3.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Rahime Bedir Findik principal investigator
Ankara City Hospital Bilkent
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 Cystocele, run by Ankara City Hospital Bilkent 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?
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: finished, as of the sponsor's last update on 28 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pelvic Organ Prolapse Quantification (POP-Q) (time frame: Maximum 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06410469, which also lists 1 linked publication.
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 May 2024.