Pelvic Floor DisfunctionNCT07903610
Comparison of Reciprocal-crossover McCall Culdoplasty and Conventional McCall Culdoplasty
An observational study of Pelvic Floor Disfunction and Urogynecologic Surgery, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
In this study, our aim is to compare pelvic floor examination findings and quality-of-life satisfaction data between a group that underwent "reciprocal-suture McCall culdoplasty with simultaneous fixation of the ovarian proper ligament"-performed to reduce the risk of POP recurrence following vaginal hysterectomy-and… Read more about this study
- Who is it for?
- Ages 30 to 90 years, women only
- Conditions the study is for
- Pelvic Floor Disfunction, Urogynecologic Surgery
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2026to 13 Oct 2026
- How long will I take part?
- 1 Year
- 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 30 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who McCall de plasty operation because Apical prolapse pathology
Who may be able to join
- Patients aged 30-90 years who underwent surgery for POP, Resiprocal McCall de lasty or classical McCall de plasty with additional prolapse procedures, such as anterior colporrhaphy , posterior colporrhaphy, or vaginal hysterectomy.
- Patients who had complete medical records.
- Patients for whom at least 24 months had elapsed since surgery.
Who cannot join
- • Patients who underwent other apical prolapse surgery unless McCall culdoplasty
- Patients who died during the study period.
- Patients lost to follow-up or who discontinued follow-up.
- Patients with paralysis or neurogenic bladder.
- Patients with recurrent POP following previous pelvic organ prolapse surgery.
- Patients with incomplete medical records.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Reciprocal-suture McCall Culdoplasty With Concurrent Fixation to the Utero-ovarian Ligament Versus Conventional McCall Culdoplasty in Vaginal Surgeries
In this study, our aim is to compare pelvic floor examination findings and quality-of-life satisfaction data between a group that underwent "reciprocal-suture McCall culdoplasty with simultaneous fixation of the ovarian proper ligament"-performed to reduce the risk of POP recurrence following vaginal hysterectomy-and a group that underwent classic McCall culdoplasty without this additional surgical step.
- Conditions
- Pelvic Floor Disfunction, Urogynecologic Surgery
- Keywords
- Pelvic floor surgery;, McCall de Plasti
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Resiprocal crossover McCall dePlasti | |
| Group 2 | Classical McCall de Plasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical recurrence
Presence of prolapse recurrence 2 years later, according to the simplified POP-Q system
Measured: 2 years
satisfaction in quality of life surveys
patient satisfaction with the surgery-
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 posted29 Oct 2026
- Study start1 Sep 2026
- Primary completion10 Oct 2026
- Study completion13 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DisfunctionStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 58 participants (actual)
- Target duration
- 1 Year
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 Bilkent Şehir Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903610
- Sponsor's protocol ID
- Ankara Bilkent City Hospital
- Other IDs
- uygun değil
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: pelvik organ prolapsusu konuları hasta için mahrem konu olduğu için psylsşımı uygun değil
Publications
Karadag B, Mulayim B, Karadag C, Akdas BA, Karatas S, Yuksel BA, Tatar SA. McCall culdoplasty vs. vaginally assisted laparoscopic sacrocolpopexy in the treatment of advanced uterine prolapse: A randomized controlled study. Taiwan J Obstet Gynecol. 2023 Mar;62(2):325-329. doi: 10.1016/j.tjog.2022.11.013.
PubMed 36965902Mancarella M, Testa F, Chiado Piat F, Novara L, Biglia N, Sgro LG. Fixation of uterosacral ligaments to anterior vaginal wall during modified McCall culdoplasty after vaginal hysterectomy. Eur J Obstet Gynecol Reprod Biol. 2022 Mar;270:221-226. doi: 10.1016/j.ejogrb.2022.01.012. Epub 2022 Jan 15.
PubMed 35114574Schiavi MC, Savone D, Di Mascio D, Di Tucci C, Perniola G, Zullo MA, Muzii L, Benedetti Panici P. Long-term experience of vaginal vault prolapse prevention at hysterectomy time by modified McCall culdoplasty or Shull suspension: Clinical, sexual and quality of life assessment after surgical intervention. Eur J Obstet Gynecol Reprod Biol. 2018 Apr;223:113-118. doi: 10.1016/j.ejogrb.2018.02.025. Epub 2018 Feb 27.
PubMed 29518641
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Reciprocal-suture McCall Culdoplasty With Concurrent Fixation to the Utero-ovarian Ligament Versus Conventional McCall Culdoplasty in Vaginal Surgeries
- ClinicalTrials.gov ID
- NCT07903610
- Acronym / sponsor ID
- Ankara Bilkent City Hospital
- Conditions
- Pelvic Floor Disfunction, Urogynecologic Surgery
- Keywords
- Pelvic floor surgery;, McCall de Plasti
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 10 Oct 2026 (actual)
- Study completion
- 13 Oct 2026 (actual)
- First posted
- 29 Oct 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, our aim is to compare pelvic floor examination findings and quality-of-life satisfaction data between a group that underwent "reciprocal-suture McCall culdoplasty with simultaneous fixation of the ovarian proper ligament"-performed to reduce the risk of POP recurrence following vaginal hysterectomy-and a group that underwent classic McCall culdoplasty without this additional surgical step.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Resiprocal crossover McCall dePlasti |
| Group 2 | – | –Classical McCall de Plasty |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who McCall de plasty operation because Apical prolapse pathology
Key inclusion criteria (3 listed)
- Patients aged 30-90 years who underwent surgery for POP, Resiprocal McCall de lasty or classical McCall de plasty with additional prolapse procedures, such as anterior colporrhaphy , posterior colporrhaphy, or vaginal hysterectomy.
Key exclusion criteria (6 listed)
- • Patients who underwent other apical prolapse surgery unless McCall culdoplasty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anatomical recurrence
Time frame: 2 years
Presence of prolapse recurrence 2 years later, according to the simplified POP-Q system
satisfaction in quality of life surveys
Time frame: 2 years
patient satisfaction with the surgery-
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 30 Oct 2026.
- Background: PubMed 36965902Karadag B, Mulayim B, Karadag C, Akdas BA, Karatas S, Yuksel BA, Tatar SA. McCall culdoplasty vs. vaginally assisted laparoscopic sacrocolpopexy in the treatment of advanced uterine prolapse: A randomized controlled study. Taiwan J Obstet Gynecol. 2023 Mar;62(2):325-329. doi: 10.1016/j.tjog.2022.11.013.
- Background: PubMed 35114574Mancarella M, Testa F, Chiado Piat F, Novara L, Biglia N, Sgro LG. Fixation of uterosacral ligaments to anterior vaginal wall during modified McCall culdoplasty after vaginal hysterectomy. Eur J Obstet Gynecol Reprod Biol. 2022 Mar;270:221-226. doi: 10.1016/j.ejogrb.2022.01.012. Epub 2022 Jan 15.
- Background: PubMed 29518641Schiavi MC, Savone D, Di Mascio D, Di Tucci C, Perniola G, Zullo MA, Muzii L, Benedetti Panici P. Long-term experience of vaginal vault prolapse prevention at hysterectomy time by modified McCall culdoplasty or Shull suspension: Clinical, sexual and quality of life assessment after surgical intervention. Eur J Obstet Gynecol Reprod Biol. 2018 Apr;223:113-118. doi: 10.1016/j.ejogrb.2018.02.025. Epub 2018 Feb 27.
- Individual participant dataSharing planned: No. pelvik organ prolapsusu konuları hasta için mahrem konu olduğu için psylsşımı uygun değil
Related trials for Pelvic Floor Disfunction
Recruiting
The Impact of Osteopathic Manipulative Treatment on Pelvic Floor Dysfunction, Activity, and Gait in Female Runners
Pelvic Floor Disfunction
Not yet recruiting
Assessment of Effectiveness of Pelvic Floor Muscle Training With Biofeedback in Male With Hypogonadism and Erectile Dysfunction
Erectile Disfunction, Hypogonadal Males
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 Bilkent Şehir Hastanesi
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 Pelvic Floor Disfunction and Urogynecologic Surgery, 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 6 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 30 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 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?
Anatomical recurrence (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT07903610, which also lists 3 linked publications.
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 30 Oct 2026.