Genital ProlapseNCT07306715
Laparoscopic Pectopexy With and Without Mesh Use for Pelvic Organ Prolapse.
A study testing Meshless Laparoscopic Pectopexy and Laparoscopic Pectopexy with mesh in people with Genital Prolapse, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Genital apical prolapse refers to the descent of the vaginal apex, uterus, or cervix, and surgical treatment is required for adequate apical support. Laparoscopic pectopexy is a surgical method developed as an alternative to the gold standard, sacrocolpopexy, in the treatment of genital organ prolapse, especially for… Read more about this study
- Who is it for?
- Ages 40 to 80 years, women only
- Conditions the study is for
- Genital Prolapse
- What is being tested?
- Meshless Laparoscopic Pectopexy and Laparoscopic Pectopexy with mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Jan 2026to 1 Jun 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 40 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients older than 40 years and younger than 80 years old with symptomatic uterine prolapse
- Patients who provided written consent for the surgical procedure
- Patients who do not wish to preserve their uterus
Who cannot join
- Patients who cannot obtain anesthesia approval for laparoscopic surgery
- Patients who have a confirmed or suspected pregnancy
- Patients who have abnormal uterine/cervical/vaginal bleeding
- Patients with biopsy-confirmed endometrial hyperplasia or cervical dysplasia
- Patients with pathology-confirmed genital cancer
- Patients undergone chemotherapy or radiotherapy for any type of cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kocaeli University, School of Medicine
Köseköy, Kocaeli, 41380
Şener Gezer, Asoc. Prof. Dr., +90 372 303 2525, dr.senergezer@gmail.com
About this study
Official title: Comparison of Pectopexy Operations With and Without Mesh Use After Laparoscopic Hysterectomy for Pelvic Organ Prolapse.
Genital apical prolapse refers to the descent of the vaginal apex, uterus, or cervix, and surgical treatment is required for adequate apical support. Laparoscopic pectopexy is a surgical method developed as an alternative to the gold standard, sacrocolpopexy, in the treatment of genital organ prolapse, especially for obese patients for whom dissection is difficult. The vaginal cuff is attached to the pectineal ligament with polypropylene mesh in the standard technique. The use of mesh is subject to serious restrictions due to complications such as mesh erosion. Surgical methods without using a mesh may be safer treatment options for patients with genital prolapse. This study aimed to compare the results of Laparoscopic Pectopexy surgery with and without the use of mesh material after hysterectomy.
Read the detailed description
After ethics committee approval, patients with stage 2 and above pelvic organ prolapse according to the POP-Q staging system, who have completed their fertile period and do not want uterus preservation, will be included in the study. The stage of prolapse according to POP-Q and other gynecological examination findings will be recorded at the initial examination. Prolapse and its impact on the quality of life will be recorded preoperatively and 12 months postoperatively with the Prolapse Quality of Life Questionnaire (P-QOL). Patients will be called for examination 12 months after the operation. The ratio of women with stage 2 or greater vaginal cuff prolapse according to the Pelvic Organ Prolapse Quantification (POP-Q) system is the main outcome of the study.
- Conditions
- Genital Prolapse
- Being tested
- Meshless Laparoscopic Pectopexy, Laparoscopic Pectopexy with mesh
- Keywords
- pectopexy, mesh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meshless Laparoscopic PectopexyProcedure or surgery
The vaginal cuff will be fixed to the pectineal ligament with No. 1, non-absorbable Prolene suture.
Laparoscopic Pectopexy with meshProcedure or surgery
The vaginal cuff will be fixed to the pectineal ligament with polypropylene mesh.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Pectopexy without mesh | Experimental | In this group of patients, the Laparoscopic Pectopexy operation will be performed without the use of mesh material after hysterectomy. Not using mesh will be protective against possible erosion reactions that may develop in the postoperative period. Laparoscopic hysterectomy is performed using the standard procedure with a uterine manipulator; after sealing the uterine arteries, the vagina is cut at the level of the uterine manipulator cuff and sutured. The vaginal cuff will be fixed to the pectineal ligament with No. 1, non-absorbable Prolene suture. Receives: Procedure: Meshless Laparoscopic Pectopexy |
| Laparoscopic Pectopexy with mesh | Active comparator | In this group of patients, the Laparoscopic Pectopexy operation will be performed using mesh material after hysterectomy. Laparoscopic hysterectomy is performed using the standard procedure with a uterine manipulator; after sealing the uterine arteries, the vagina is cut at the level of the uterine manipulator cuff and sutured. The vaginal cuff will be fixed to the pectineal ligament with polypropylene mesh. Receives: Procedure: Laparoscopic Pectopexy with mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apical descensus relapse rate
The ratio of women with stage 2 or greater vaginal cuff prolapse according to the Pelvic Organ Prolapse Quantification (POP-Q) system.
Measured: 12 months after surgery
Secondary outcomes (1)
Prolapse Quality of Life (P-QOL)
The questionnaire has nine items, each of which has a 4-point scoring system and a total score of 0-100. A high total score indicates worsening of the quality of life of women with pelvic organ prolapse.
Measured: Preoperative day and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start29 Jan 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Genital ProlapseStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şener Gezer, Kocaeli University
- Investigators
- İsmail Bıyık, M.D., Study chair, Kütahya Sağlık Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306715
- Sponsor's protocol ID
- KAEK/18.bI.02
- Status last verified
- Jan 2026
- First submitted
- 14 Dec 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Erdem B, Salman S, Usta ZK, Bacak HB, Ozkan MD, Ceken AT, Isik EY, Kumbasar S, Gencer FK, Baghaki HS, Kacar T, Aslan GN, Bulut B. A Novel Approach for Apical Prolapse Surgery: Meshless Pectopexy (Salman's Modification). Int Urogynecol J. 2025 Aug;36(8):1701-1705. doi: 10.1007/s00192-025-06107-z. Epub 2025 Apr 1.
PubMed 40167602Aleksandrov A, Smith AV, Rabischong B, Botchorishvili R. Mesh-less laparoscopic treatment of apical prolapse. Facts Views Vis Obgyn. 2021 Jun;13(2):179-181. doi: 10.52054/FVVO.13.2.013.
PubMed 34184848
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pectopexy Operations With and Without Mesh Use After Laparoscopic Hysterectomy for Pelvic Organ Prolapse.
- ClinicalTrials.gov ID
- NCT07306715
- Acronym / sponsor ID
- KAEK/18.bI.02
- Conditions
- Genital Prolapse
- Keywords
- pectopexy, mesh
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 29 Dec 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.
Genital apical prolapse refers to the descent of the vaginal apex, uterus, or cervix, and surgical treatment is required for adequate apical support. Laparoscopic pectopexy is a surgical method developed as an alternative to the gold standard, sacrocolpopexy, in the treatment of genital organ prolapse, especially for obese patients for whom dissection is difficult. The vaginal cuff is attached to the pectineal ligament with polypropylene mesh in the standard technique. The use of mesh is subject to serious restrictions due to complications such as mesh erosion. Surgical methods without using a mesh may be safer treatment options for patients with genital prolapse. This study aimed to compare the results of Laparoscopic Pectopexy surgery with and without the use of mesh material after hysterectomy.
Detailed description
After ethics committee approval, patients with stage 2 and above pelvic organ prolapse according to the POP-Q staging system, who have completed their fertile period and do not want uterus preservation, will be included in the study. The stage of prolapse according to POP-Q and other gynecological examination findings will be recorded at the initial examination. Prolapse and its impact on the quality of life will be recorded preoperatively and 12 months postoperatively with the Prolapse Quality of Life Questionnaire (P-QOL). Patients will be called for examination 12 months after the operation. The ratio of women with stage 2 or greater vaginal cuff prolapse according to the Pelvic Organ Prolapse Quantification (POP-Q) system is the main outcome of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Pectopexy without mesh | Experimental | Procedure: Meshless Laparoscopic PectopexyIn this group of patients, the Laparoscopic Pectopexy operation will be performed without the use of mesh material after hysterectomy. Not using mesh will be protective against possible erosion reactions that may develop in the postoperative period. Laparoscopic hysterectomy is performed using the standard procedure with a uterine manipulator; after sealing the uterine arteries, the vagina is cut at the level of the uterine manipulator cuff and sutured. The vaginal cuff will be fixed to the pectineal ligament with No. 1, non-absorbable Prolene suture. |
| Laparoscopic Pectopexy with mesh | Active comparator | Procedure: Laparoscopic Pectopexy with meshIn this group of patients, the Laparoscopic Pectopexy operation will be performed using mesh material after hysterectomy. Laparoscopic hysterectomy is performed using the standard procedure with a uterine manipulator; after sealing the uterine arteries, the vagina is cut at the level of the uterine manipulator cuff and sutured. The vaginal cuff will be fixed to the pectineal ligament with polypropylene mesh. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients older than 40 years and younger than 80 years old with symptomatic uterine prolapse
- Patients who provided written consent for the surgical procedure
- Patients who do not wish to preserve their uterus
Key exclusion criteria (6 listed)
- Patients who cannot obtain anesthesia approval for laparoscopic surgery
- Patients who have a confirmed or suspected pregnancy
- Patients who have abnormal uterine/cervical/vaginal bleeding
- Patients with biopsy-confirmed endometrial hyperplasia or cervical dysplasia
- Patients with pathology-confirmed genital cancer
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 |
|---|---|---|
| Meshless Laparoscopic PectopexyThe vaginal cuff will be fixed to the pectineal ligament with No. 1, non-absorbable Prolene suture. | Procedure or surgery | Laparoscopic Pectopexy without mesh |
| Laparoscopic Pectopexy with meshThe vaginal cuff will be fixed to the pectineal ligament with polypropylene mesh. | Procedure or surgery | Laparoscopic Pectopexy with mesh |
Primary outcome
Apical descensus relapse rate
Time frame: 12 months after surgery
The ratio of women with stage 2 or greater vaginal cuff prolapse according to the Pelvic Organ Prolapse Quantification (POP-Q) system.
1 secondary outcome
Prolapse Quality of Life (P-QOL)
Time frame: Preoperative day and 12 months after surgery
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 2 Feb 2026.
- Background: PubMed 40167602Erdem B, Salman S, Usta ZK, Bacak HB, Ozkan MD, Ceken AT, Isik EY, Kumbasar S, Gencer FK, Baghaki HS, Kacar T, Aslan GN, Bulut B. A Novel Approach for Apical Prolapse Surgery: Meshless Pectopexy (Salman's Modification). Int Urogynecol J. 2025 Aug;36(8):1701-1705. doi: 10.1007/s00192-025-06107-z. Epub 2025 Apr 1.
- Background: PubMed 34184848Aleksandrov A, Smith AV, Rabischong B, Botchorishvili R. Mesh-less laparoscopic treatment of apical prolapse. Facts Views Vis Obgyn. 2021 Jun;13(2):179-181. doi: 10.52054/FVVO.13.2.013.
- Individual participant dataSharing planned: No
Related trials for Genital Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
Active, not recruiting
Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse
Uterine Prolapse
Recruiting
Functional Links Between the Temporomandibular Joint and the Pelvis in Gynecology
Prolapse; Female, Endometriosis-related Pain
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.
İsmail Bıyık, M.D. study chair
Kütahya Sağlık Bilimleri University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meshless Laparoscopic Pectopexy and Laparoscopic Pectopexy with mesh in people with Genital Prolapse, run by Kocaeli University 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: looking for participants now, as of the sponsor's last update on 2 Feb 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?
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 Şener Gezer, M.D. (+903723037575, dr.senergezer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apical descensus relapse rate (time frame: 12 months after surgery). 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 NCT07306715, which also lists 2 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 2 Feb 2026.