Pelvic Organ ProlapseNCT04508062
Effects of the Addition of Uterosacral Ligament Plication to Pectopexy Operation on Anatomical and Subjective Symptoms
A study testing pectopexy operation and uterosacral ligaments plication operation. in people with Pelvic Organ Prolapse, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The investigators planned to measure the effectiveness of laparoscopic pectopexy in apical prolapse and whether the addition of sacrouterine ligaments plication to pectopexy increases the effectiveness of pectopexy operation. Read more about this study
- Who is it for?
- Ages 25 to 75 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- pectopexy operation and uterosacral ligaments plication operation.
- 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
- 6 Aug 2020to 6 Mar 2022
- 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 25 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with stage II-IV apical compartment defect according to the POP-Q classification
Who cannot join
- having severe chronic disease that makes the operation dangerous
- patients under 25 and patients over 75 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the Addition of Uterosacral Ligament Plication to Pectopexy Operation on Anatomical and Subjective Symptoms in the Treatment of Apical Compartment Defects
The investigators planned to measure the effectiveness of laparoscopic pectopexy in apical prolapse and whether the addition of sacrouterine ligaments plication to pectopexy increases the effectiveness of pectopexy operation. Investigators planned to measure patients' quality of life using the female sexual function scale test 3, 6 and 12 months after the surgery and to determine how the operation affects the quality of sexual life.
Read the detailed description
In this study, the investigators planned to measure the effectiveness of laparoscopic pectopexy in apical prolapse and whether the addition of sacrouterine ligaments plication to pectopexy increases the effectiveness of pectopexy operation. Investigators planned to measure patients' quality of life using the female sexual function scale test 3, 6 and 12 months after the surgery and to determine how the operation affects the quality of sexual life.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- pectopexy operation, uterosacral ligaments plication operation.
- Keywords
- pelvic organ prolapse, pectopexy, laparoscopy, uterosacral ligaments plication
- 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.
pectopexy operationProcedure or surgery
Vaginal cuff or uterine cervix will be attached to iliopectineal ligament with polypropylene mesh on both sides.
uterosacral ligaments plication operation.Procedure or surgery
At least 2/3 of the sacrouterine ligaments will be shortened with helical sutures, starting from the cervix and so douglas will be partially obliterated.
| Study group | Role | What they receive |
|---|---|---|
| pectopexy group | Active comparator | this group will only have pectopexy operation Receives: Procedure: pectopexy operation |
| Pectopexy and uterosacral ligaments plication group | Active comparator | this group will have pectopexy operation with bilateral uterosacral ligaments plication Receives: Procedure: pectopexy operation; Procedure: uterosacral ligaments plication operation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
questionnaire of lower urinary tract symptoms
the questionaire examines these titles by scoring from one to ten points:
- sudden feeling of ürination
- sudden feeling of urination with incontinence
- Frequent urination
- Difficulty of starting the urination
- Abnormal discharge of urine
- nocturia
- dyspareunia
- Stress urinary incontinence
- dysuria
- constipation
Measured: changes in symptoms for each title at the preoperative day 1 and postoperative day 3 period
evaluation of sexual function with Women's Sexual Function Index
Women's Sexual Function Index is a questionnaire about sexual functions of the women. the index definex sexual functions with some questions and scorings.
Measured: changes at the preoperative day 1 and postoperative day 40 period
Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification
Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification
Measured: changes in the stage of apical compartment defect at the preoperative day 1 and postoperative day 3 period according to POP-Q clasification
Secondary outcomes (3)
evaluation of sexual function with Women's Sexual Function Index
Women's Sexual Function Index is a questionnaire about sexual functions of the women. the index definex sexual functions with some questions and scorings.
Measured: changes at 3,6 and 12. month after surgery
Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification
Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification
Measured: changes at 3,6 and 12. month after surgery
questionnaire of lower urinary tract symptoms
the questionaire examines these titles by scoring from one to ten points:
- sudden feeling of ürination
- sudden feeling of urination with incontinence
- Frequent urination
- Difficulty of starting the urination
- Abnormal discharge of urine
- nocturia
- dyspareunia
- Stress urinary incontinence
- dysuria
- constipation
Measured: changes in symptoms for each title at 3,6 and 12. month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start6 Aug 2020
- Primary completion6 Mar 2021
- Study completion6 Mar 2022
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 Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Nur Cimilli Şenocak, Ataturk University
- Investigators
- Gamze Nur Cimilli Senocak, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508062
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/6
- Status last verified
- Apr 2023
- First submitted
- 29 May 2020
- Last updated
- 24 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kumtepe Y, Senocak GNC, Sivaslioglu AA, Yapar A, Yilmaz EPT, Kasali K. A Randomised Trial on the Effects of the Addition of Uterosacral Ligament Plication to Pectopexy Operation on Anatomical Restoration and Female Sexual Functions. Int Urogynecol J. 2024 Jun;35(6):1145-1154. doi: 10.1007/s00192-024-05771-x. Epub 2024 Apr 29.
PubMed 38683391
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Addition of Uterosacral Ligament Plication to Pectopexy Operation on Anatomical and Subjective Symptoms in the Treatment of Apical Compartment Defects
- ClinicalTrials.gov ID
- NCT04508062
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/6
- Conditions
- Pelvic Organ Prolapse
- Keywords
- pelvic organ prolapse, pectopexy, laparoscopy, uterosacral ligaments plication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- 6 Mar 2021 (actual)
- Study completion
- 6 Mar 2022 (actual)
- First posted
- 11 Aug 2020 (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 investigators planned to measure the effectiveness of laparoscopic pectopexy in apical prolapse and whether the addition of sacrouterine ligaments plication to pectopexy increases the effectiveness of pectopexy operation. Investigators planned to measure patients' quality of life using the female sexual function scale test 3, 6 and 12 months after the surgery and to determine how the operation affects the quality of sexual life.
Detailed description
In this study, the investigators planned to measure the effectiveness of laparoscopic pectopexy in apical prolapse and whether the addition of sacrouterine ligaments plication to pectopexy increases the effectiveness of pectopexy operation. Investigators planned to measure patients' quality of life using the female sexual function scale test 3, 6 and 12 months after the surgery and to determine how the operation affects the quality of sexual life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pectopexy group | Active comparator | Procedure: pectopexy operationthis group will only have pectopexy operation |
| Pectopexy and uterosacral ligaments plication group | Active comparator | Procedure: pectopexy operation, Procedure: uterosacral ligaments plication operation.this group will have pectopexy operation with bilateral uterosacral ligaments plication |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with stage II-IV apical compartment defect according to the POP-Q classification
Key exclusion criteria (2 listed)
- having severe chronic disease that makes the operation dangerous
- patients under 25 and patients over 75 years old
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 |
|---|---|---|
| pectopexy operationVaginal cuff or uterine cervix will be attached to iliopectineal ligament with polypropylene mesh on both sides. | Procedure or surgery | Pectopexy and uterosacral ligaments plication group, pectopexy group |
| uterosacral ligaments plication operation.At least 2/3 of the sacrouterine ligaments will be shortened with helical sutures, starting from the cervix and so douglas will be partially obliterated. | Procedure or surgery | Pectopexy and uterosacral ligaments plication group |
Primary outcome
questionnaire of lower urinary tract symptoms
Time frame: changes in symptoms for each title at the preoperative day 1 and postoperative day 3 period
the questionaire examines these titles by scoring from one to ten points: 1. sudden feeling of ürination 2. sudden feeling of urination with incontinence 3. Frequent urination 4. Difficulty of starting the urination 5. Abnormal discharge of urine 6. nocturia 7. dyspareunia 8. Stress urinary incontinence 9. dysuria 10. constipation
evaluation of sexual function with Women's Sexual Function Index
Time frame: changes at the preoperative day 1 and postoperative day 40 period
Women's Sexual Function Index is a questionnaire about sexual functions of the women. the index definex sexual functions with some questions and scorings.
Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification
Time frame: changes in the stage of apical compartment defect at the preoperative day 1 and postoperative day 3 period according to POP-Q clasification
Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification
3 secondary outcomes
evaluation of sexual function with Women's Sexual Function Index
Time frame: changes at 3,6 and 12. month after surgery
Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification
Time frame: changes at 3,6 and 12. month after surgery
questionnaire of lower urinary tract symptoms
Time frame: changes in symptoms for each title at 3,6 and 12. month 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 24 Apr 2023.
- Derived from this study: PubMed 38683391Kumtepe Y, Senocak GNC, Sivaslioglu AA, Yapar A, Yilmaz EPT, Kasali K. A Randomised Trial on the Effects of the Addition of Uterosacral Ligament Plication to Pectopexy Operation on Anatomical Restoration and Female Sexual Functions. Int Urogynecol J. 2024 Jun;35(6):1145-1154. doi: 10.1007/s00192-024-05771-x. Epub 2024 Apr 29.
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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.
Gamze Nur Cimilli Senocak principal investigator
Ataturk 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 pectopexy operation and uterosacral ligaments plication operation. in people with Pelvic Organ Prolapse, run by Ataturk 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 1 inclusion and 2 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 24 Apr 2023. 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?
questionnaire of lower urinary tract symptoms (time frame: changes in symptoms for each title at the preoperative day 1 and postoperative day 3 period). The study lists 3 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 NCT04508062, 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 24 Apr 2023.