Pelvic Organ ProlapseNCT05715489
Pectopexy Surgery Without Mesh
A study testing Comparison of pre and postoperative POP-Q values of the patients and Comparison of pre and postoperative PISQ-12 scores of the patients in people with Pelvic Organ Prolapse, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
it is aimed to examine the effect of laparoscopic pectopexy surgery without mesh on Pelvic Organ Prolapse Measurement (POP-Q) and quality of life of the patient. Read more about this study
- Who is it for?
- Ages 30 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Comparison of pre and postoperative POP-Q values of the patients and Comparison of pre and postoperative PISQ-12 scores of the patients
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 May 2022to 11 May 2024
- Phase
- Interventional
- 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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- having pelvic organ prolapse greater than stage 2 according to POP-Q evaluation system
- being sexually active
Who cannot join
- Disease requiring chronic steroid use
- Asthma
- Having chronic obstructive pulmonary disease
- Having malignancy,
- Having metabolic and rheumatological diseases that impair tissue healing, such as scleroderma
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Training and Research Hospital
Istanbul
About this study
Official title: Evaluation of the Results of Laparoscopic Pectopexy Surgery Without Using Mesh
it is aimed to examine the effect of laparoscopic pectopexy surgery without mesh on Pelvic Organ Prolapse Measurement (POP-Q) and quality of life of the patient.
Read the detailed description
Every gynecological patient with prolapse is evaluated with POP-Q staging. The POP-Q staging to be performed before the laparoscopic pectopexy operation without mesh (performed by using non-melting sutures with natural tissue repair) performed on the patients will be compared with the POP-Q staging that will be performed 6 months after the operation. In addition, the quality of life of patients before and 6 months after the operation will be compared with the incontinence quality of life scale questionnaire of Pelvic Organ Prolapse / Incontinence Sexual Questionnaire (PISQ-12).
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Comparison of pre and postoperative POP-Q values of the patients, Comparison of pre and postoperative PISQ-12 scores of the patients
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of pre and postoperative POP-Q values of the patientsProcedure or surgery
Pectopexy Without Using Mesh will be applied to the patients and POP-Q values will be compared pre and postoperatively
Comparison of pre and postoperative PISQ-12 scores of the patientsProcedure or surgery
Pectopexy Without Using Mesh will be applied to the patients and PISQ-12 scores will be compared pre and postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Patients with pelvic organ prolapse undergone pectopexy without using mesh | Other | Not described Receives: Procedure: Comparison of pre and postoperative POP-Q values of the patients; Procedure: Comparison of pre and postoperative PISQ-12 scores of the patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre and post operative assessment of POP-Q measurements
POP-Q values of patients before and after laparoscopic pectopexy surgery without mesh on Pelvic Organ Prolapse will be compared.
Measured: 2 year
Pre and post operative assessment of Pelvic Organ Prolapse / Incontinence Sexual
Units on a scale of the patients obtained with Pelvic Organ Prolapse / Incontinence Sexual Questionnaire (PISQ-12) will be compared before and after surgery.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start11 May 2022
- Primary completion11 May 2024
- Study completion11 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Süleyman Salman, Gaziosmanpasa Research and Education Hospital
- Investigators
- Suleyman Salman, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715489
- Sponsor's protocol ID
- GaziosmanpaşaTREHy
- Status last verified
- Sep 2024
- First submitted
- 18 Jan 2023
- Last updated
- 1 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Results of Laparoscopic Pectopexy Surgery Without Using Mesh
- ClinicalTrials.gov ID
- NCT05715489
- Acronym / sponsor ID
- GaziosmanpaşaTREHy
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 11 May 2022 (actual)
- Primary completion
- 11 May 2024 (actual)
- Study completion
- 11 May 2024 (actual)
- First posted
- 8 Feb 2023 (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.
it is aimed to examine the effect of laparoscopic pectopexy surgery without mesh on Pelvic Organ Prolapse Measurement (POP-Q) and quality of life of the patient.
Detailed description
Every gynecological patient with prolapse is evaluated with POP-Q staging. The POP-Q staging to be performed before the laparoscopic pectopexy operation without mesh (performed by using non-melting sutures with natural tissue repair) performed on the patients will be compared with the POP-Q staging that will be performed 6 months after the operation. In addition, the quality of life of patients before and 6 months after the operation will be compared with the incontinence quality of life scale questionnaire of Pelvic Organ Prolapse / Incontinence Sexual Questionnaire (PISQ-12).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with pelvic organ prolapse undergone pectopexy without using mesh | Other | Procedure: Comparison of pre and postoperative POP-Q values of the patients, Procedure: Comparison of pre and postoperative PISQ-12 scores of the patients |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- having pelvic organ prolapse greater than stage 2 according to POP-Q evaluation system
- being sexually active
Key exclusion criteria (5 listed)
- Disease requiring chronic steroid use
- Asthma
- Having chronic obstructive pulmonary disease
- Having malignancy,
- Having metabolic and rheumatological diseases that impair tissue healing, such as scleroderma
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 |
|---|---|---|
| Comparison of pre and postoperative POP-Q values of the patientsPectopexy Without Using Mesh will be applied to the patients and POP-Q values will be compared pre and postoperatively | Procedure or surgery | Patients with pelvic organ prolapse undergone pectopexy without using mesh |
| Comparison of pre and postoperative PISQ-12 scores of the patientsPectopexy Without Using Mesh will be applied to the patients and PISQ-12 scores will be compared pre and postoperatively | Procedure or surgery | Patients with pelvic organ prolapse undergone pectopexy without using mesh |
Primary outcome
Pre and post operative assessment of POP-Q measurements
Time frame: 2 year
POP-Q values of patients before and after laparoscopic pectopexy surgery without mesh on Pelvic Organ Prolapse will be compared.
Pre and post operative assessment of Pelvic Organ Prolapse / Incontinence Sexual
Time frame: 2 year
Units on a scale of the patients obtained with Pelvic Organ Prolapse / Incontinence Sexual Questionnaire (PISQ-12) will be compared before and after 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 1 Oct 2024.
- Individual participant dataSharing planned: Yes
Related trials for Pelvic Organ Prolapse
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Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
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Suzetrigine Following Urogynecologic Surgery: Investigation of Postoperative Pain Management
Pelvic Organ Prolapse (POP), Postoperative Pain
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Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse
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Clinical Outcomes of Rectopexy for Rectal Prolapse
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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.
Suleyman Salman principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison of pre and postoperative POP-Q values of the patients and Comparison of pre and postoperative PISQ-12 scores of the patients in people with Pelvic Organ Prolapse, run by Gaziosmanpasa Research and Education Hospital 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 2 inclusion and 5 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 1 Oct 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?
Pre and post operative assessment of POP-Q measurements (time frame: 2 year). 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?
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 1 Oct 2024.