CystoceleNCT07336108
RUG-WEAVING PLICATION IN CYSTOCELE TREATMENT
An observational study of Cystocele, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
In this study was to compare the 2-year results of the Rug Wave plication technique, which it present as a natural tissue repair technique in cystocele, with the conventional technique in terms of both recurrence and patient quality of life satisfaction scales. 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 and group 2:conventional technique cystocele treatment
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 15 Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Women operated on for anterior wall prolapse in POP-Q
Who may be able to join
- Patients operated on using the rug weaving plication technique
- Patients operated on using the conventional anterior colporrhaphy
- Exclusion Criteria:Patients who did not undergo cystocele surgery were excluded from the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Ankara, 06200
About this study
Official title: RUG-WEAVING PLICATION TECHNIQUE RESULTS IN CYSTOCELE TREATMENT:TWO YEAR FOLLOW-UP
In this study was to compare the 2-year results of the Rug Wave plication technique, which it present as a natural tissue repair technique in cystocele, with the conventional technique in terms of both recurrence and patient quality of life satisfaction scales.
Read the detailed description
The study was planned as a retrospective case-control observational study. It included 60 patients who underwent surgery solely for cystocele or cystocel with other organ prolapse conditions; of them, 29 received the rug-weaving plication technique, a natural tissue repair method implemented for anterior wall defects since 2022, and 31 underwent conventional anterior colporrhaphy.Data were collected in 2 groups. In Group 1, there were data of 29 patients who were operated for cystocele with the Rug Wave technique and Group 2, there were data of 31 patients who were operated with the classical colporrhaphy technique. Data from these patients were recorded at 6 months and 2 years postoperatively. At the 6 months and 2 years postoperative follow-up, it assessed patients' complaints, degree of prolapse (using the simplified Pelvic Organ Prolapse Quantification system), pelvic floor muscle strength (using the Modified Oxford Score) and the anterior vaginal wall thickness in transvaginal ultrasound. In addition, the data of the questionnaire applied to the patients in the 2nd year were also recorded(Pelvic Floor Distress Inventory, Sandvik Severity Index, Overactive bladder, Surgical satisfaction questionnaire, Patient global impression of improvement questionnaire, Pelvic Organ Prolapsed / Urinary Incontinence Sexual Questionnaire, Incontinence Impact Questionnaire).The results of the two groups were compared.Data were entered and analyzed in SPSS program. Mann-Whitney -U test, Independent simple test, Chi-Square test were used in group comparisons. Chi-Square test was used to compare categorical variables; Mann-Whitney U test was used to compare continuous variables that were not normally distributed; Independent Simple test was used to evaluate the significance of the differences between the means of continuous variables between two groups.
- Conditions
- Cystocele
- Being tested
- rug weaving-like plication technique, group 2:conventional technique cystocele treatment
- 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
Rug Waeving plication technique :This technique is a technique that has not been used before.
group 2:conventional technique cystocele treatmentProcedure or surgery
Patients operated on using the conventional anterior colporrhaphy
| Study group | Role | What they receive |
|---|---|---|
| Group 1:there were data of 29 patients who were operated for cystocele with the Rug Wave techniq | Rug Waiving plication techniqe Receives: Procedure: rug weaving-like plication technique | |
| Group 2: 31 patients who underwent surgery using conventional colporrhaphy. | anterior vaginal wall repair with theconventional technique in cystosel Receives: Procedure: group 2:conventional technique cystocele treatment |
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
The POP-Q staging system, introduced in 1996 and widely accepted as the standard quantitative classification system for pelvic organ prolapse, was utilized in this study. 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. Figure -1 schematically shows the POP-Q staging system .
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Dec 2025
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
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
- 60 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336108
- Sponsor's protocol ID
- There is no sponsor.
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: due to patient privacy
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 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RUG-WEAVING PLICATION TECHNIQUE RESULTS IN CYSTOCELE TREATMENT:TWO YEAR FOLLOW-UP
- ClinicalTrials.gov ID
- NCT07336108
- Acronym / sponsor ID
- There is no sponsor.
- Conditions
- Cystocele
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 13 Jan 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.
In this study was to compare the 2-year results of the Rug Wave plication technique, which it present as a natural tissue repair technique in cystocele, with the conventional technique in terms of both recurrence and patient quality of life satisfaction scales.
Detailed description
The study was planned as a retrospective case-control observational study. It included 60 patients who underwent surgery solely for cystocele or cystocel with other organ prolapse conditions; of them, 29 received the rug-weaving plication technique, a natural tissue repair method implemented for anterior wall defects since 2022, and 31 underwent conventional anterior colporrhaphy.Data were collected in 2 groups. In Group 1, there were data of 29 patients who were operated for cystocele with the Rug Wave technique and Group 2, there were data of 31 patients who were operated with the classical colporrhaphy technique. Data from these patients were recorded at 6 months and 2 years postoperatively. At the 6 months and 2 years postoperative follow-up, it assessed patients' complaints, degree of prolapse (using the simplified Pelvic Organ Prolapse Quantification system), pelvic floor muscle strength (using the Modified Oxford Score) and the anterior vaginal wall thickness in transvaginal ultrasound. In addition, the data of the questionnaire applied to the patients in the 2nd year were also recorded(Pelvic Floor Distress Inventory, Sandvik Severity Index, Overactive bladder, Surgical satisfaction questionnaire, Patient global impression of improvement questionnaire, Pelvic Organ Prolapsed / Urinary Incontinence Sexual Questionnaire, Incontinence Impact Questionnaire).The results of the two groups were compared.Data were entered and analyzed in SPSS program. Mann-Whitney -U test, Independent simple test, Chi-Square test were used in group comparisons. Chi-Square test was used to compare categorical variables; Mann-Whitney U test was used to compare continuous variables that were not normally distributed; Independent Simple test was used to evaluate the significance of the differences between the means of continuous variables between two groups.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1:there were data of 29 patients who were operated for cystocele with the Rug Wave techniq | – | Procedure: rug weaving-like plication techniqueRug Waiving plication techniqe |
| Group 2: 31 patients who underwent surgery using conventional colporrhaphy. | – | Procedure: group 2:conventional technique cystocele treatmentanterior vaginal wall repair with theconventional technique in cystosel |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women operated on for anterior wall prolapse in POP-Q
Key inclusion criteria (3 listed)
- Patients operated on using the rug weaving plication technique
- Patients operated on using the conventional anterior colporrhaphy
- Exclusion Criteria:Patients who did not undergo cystocele surgery were excluded from the study.
Key exclusion criteria (0 listed)
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 techniqueRug Waeving plication technique :This technique is a technique that has not been used before. | Procedure or surgery | Group 1:there were data of 29 patients who were operated for cystocele with the Rug Wave techniq |
| group 2:conventional technique cystocele treatmentPatients operated on using the conventional anterior colporrhaphy | Procedure or surgery | Group 2: 31 patients who underwent surgery using conventional colporrhaphy. |
Primary outcome
Pelvic Organ Prolapse Quantification (POP-Q) Postoperative anterior wall POP-Q
Time frame: 2 years
The POP-Q staging system, introduced in 1996 and widely accepted as the standard quantitative classification system for pelvic organ prolapse, was utilized in this study. 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. Figure -1 schematically shows the POP-Q staging system .
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 13 Jan 2026.
- Background: 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: No. due to patient privacy
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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.
The record lists no contact. Use the official record to reach the sponsor.
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?
The sponsor lists 3 inclusion and 0 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: finished, as of the sponsor's last update on 13 Jan 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 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) Postoperative anterior wall POP-Q (time frame: 2 years). 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 NCT07336108, 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 13 Jan 2026.