Pelvic Organ Prolapse (POP)NCT06975956
Evaluation of Sexual Function and Quality of Life Tests in Patients Who Underwent Manchester Operation for Pelvic Organ Prolapse
An observational study of Pelvic Organ Prolapse (POP), run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Pelvic organ prolapse is a condition that affects sexual health and quality of life at all ages. The efficacy of the Manchester operation planned in appropriate patients and its effects on the sexual function and quality of life of the patient were investigated and it was thought that uterine preservation should be… Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse (POP)
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 30 Sep 2025
- How long will I take part?
- 6 Months
- 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 18 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing Manchester operation for pelvic organ prolapse
Who may be able to join
- Patients undergoing Manchester operation for pelvic organ prolapse
Who cannot join
- Patients who refused to participate in the study. Patients undergoing hysterectomy for pelvic organ prolapse, cancer patients, patients with uterine, cervical and ovarian malignancy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bağcılar Training and Reserach Hospital
Istanbul
About this study
Pelvic organ prolapse is a condition that affects sexual health and quality of life at all ages. The efficacy of the Manchester operation planned in appropriate patients and its effects on the sexual function and quality of life of the patient were investigated and it was thought that uterine preservation should be offered as a treatment option in the young age group of patients who want uterine preservation and in cases with comorbidity and short operation time required.
Read the detailed description
Patients with ≥2 pelvic organ prolapse according to POP Q staging system who are examined in the urogynecology outpatient clinic with the complaint of prolapse will be presented to the gynecology council. As a result of P0P Q scoring, patients with cervical elongation findings with C point ≥0, D point ≤-4 and estimated cervical length ≥5 cm, age, fertility, patient's desire to preserve the uterus, comorbid diseases will be evaluated and patients who are planned for Manchester operation in the council decision will be included in the study. All patients will have undergone ultrasonography and cervical smear screening. Cervical, uterine and ovarian malignant pathologies will be excluded. Anamnesis information and test results of these patients who require operation will be obtained from the electronic information system of our hospital and the files of the patients. In the case report form, the patient's age, obstetric anamnesis, BMI (body mass index), POP Q scoring in preoperative and postoperative 6th month pelvic examination, Female Sexual Function Index (FSFI) questionnaire consisting of 19 questions to evaluate sexual life, Prolapse Quality of Questionnaire (P QOL) questionnaire consisting of 20 questions to evaluate quality of life will be performed. Duration of operation, estimated blood loss, postoperative hemogram change will be obtained from the operation records. Preoperative and postoperative 6th month POP Q scoring, sexual function and quality of life tests were evaluated.
- Conditions
- Pelvic Organ Prolapse (POP)
- Keywords
- Pelvic organ prolapse, Manchester operation
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Female patients who underwent Manchester operation for pelvic organ prolapse. | Complaints, demographic characteristics and gynecologic examinations of the patients who underwent Manchester operation will be performed. Preoperative and postoperative 6th month pelvic examination will include POP Q scoring, Female Sexual Function Index (FSFI) questionnaire consisting of 19 questions to evaluate sexual life, Prolapse Quality of Questionnaire (PQOL) consisting of 20 questions to evaluate quality of life. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sexual Function as will be measured by the Female Sexual Function Index (FSFI) in patients undergoing Manchester operation for pelvic organ prolapse.
The FSFI is a 19-item questionnaire evaluating six domains(desire, arousal, lubrication, orgasm, sexual satisfaction and pain) of female sexual function. Total scores range from 2 to 36; higher scores reflect better sexual function
Measured: Preoperative and 6 months postoperative
Change in Quality of Life as will be measured by Prolapse quality of life tests (PQOL) in patients undergoing Manchester operation for pelvic organ prolapse
PQOL questionnaire consists of 20 questions about general health perceptions, prolapse impact, role imitation, physical limitations, social limitation, personal relationships, emotions, sleep/energy, severity measures. Each section is scored with a minimum score of 0 and a maximum score of 100. A high total score indicates a greater impairment of quality of life.
Measured: Preoperative and 6 months postoperative
Change in Pelvic Organ Support as will be measured by the Pelvic Organ
The POP-Q system measures vaginal point locations relative to the hymen in centimeters (e.g., Aa, Ba, C, D points). Improvement is reflected by a reduction in positive or elevated values.
Measured: Preoperative and 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start1 Jan 2023
- Primary completion30 Aug 2025
- Study completion30 Sep 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 Pelvic Organ Prolapse (POP)Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 31 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Cemile ilhan, Bagcilar Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975956
- Sponsor's protocol ID
- 2023/23
- Status last verified
- Aug 2025
- First submitted
- 28 Apr 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Park YJ, Kong MK, Lee J, Kim EH, Bai SW. Manchester Operation: An Effective Treatment for Uterine Prolapse Caused by True Cervical Elongation. Yonsei Med J. 2019 Nov;60(11):1074-1080. doi: 10.3349/ymj.2019.60.11.1074.
PubMed 31637890
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sexual Function and Quality of Life Tests in Patients Who Underwent Manchester Operation for Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT06975956
- Acronym / sponsor ID
- 2023/23
- Conditions
- Pelvic Organ Prolapse (POP)
- Keywords
- Pelvic organ prolapse, Manchester operation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 16 May 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.
Pelvic organ prolapse is a condition that affects sexual health and quality of life at all ages. The efficacy of the Manchester operation planned in appropriate patients and its effects on the sexual function and quality of life of the patient were investigated and it was thought that uterine preservation should be offered as a treatment option in the young age group of patients who want uterine preservation and in cases with comorbidity and short operation time required.
Detailed description
Patients with ≥2 pelvic organ prolapse according to POP Q staging system who are examined in the urogynecology outpatient clinic with the complaint of prolapse will be presented to the gynecology council. As a result of P0P Q scoring, patients with cervical elongation findings with C point ≥0, D point ≤-4 and estimated cervical length ≥5 cm, age, fertility, patient's desire to preserve the uterus, comorbid diseases will be evaluated and patients who are planned for Manchester operation in the council decision will be included in the study. All patients will have undergone ultrasonography and cervical smear screening. Cervical, uterine and ovarian malignant pathologies will be excluded. Anamnesis information and test results of these patients who require operation will be obtained from the electronic information system of our hospital and the files of the patients. In the case report form, the patient's age, obstetric anamnesis, BMI (body mass index), POP Q scoring in preoperative and postoperative 6th month pelvic examination, Female Sexual Function Index (FSFI) questionnaire consisting of 19 questions to evaluate sexual life, Prolapse Quality of Questionnaire (P QOL) questionnaire consisting of 20 questions to evaluate quality of life will be performed. Duration of operation, estimated blood loss, postoperative hemogram change will be obtained from the operation records. Preoperative and postoperative 6th month POP Q scoring, sexual function and quality of life tests were evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Female patients who underwent Manchester operation for pelvic organ prolapse. | – | –Complaints, demographic characteristics and gynecologic examinations of the patients who underwent Manchester operation will be performed. Preoperative and postoperative 6th month pelvic examination will include POP Q scoring, Female Sexual Function Index (FSFI) questionnaire consisting of 19 questions to evaluate sexual life, Prolapse Quality of Questionnaire (PQOL) consisting of 20 questions to evaluate quality of life. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing Manchester operation for pelvic organ prolapse
Key inclusion criteria (1 listed)
- Patients undergoing Manchester operation for pelvic organ prolapse
Key exclusion criteria (1 listed)
- Patients who refused to participate in the study. Patients undergoing hysterectomy for pelvic organ prolapse, cancer patients, patients with uterine, cervical and ovarian malignancy.
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
Change in Sexual Function as will be measured by the Female Sexual Function Index (FSFI) in patients undergoing Manchester operation for pelvic organ prolapse.
Time frame: Preoperative and 6 months postoperative
The FSFI is a 19-item questionnaire evaluating six domains(desire, arousal, lubrication, orgasm, sexual satisfaction and pain) of female sexual function. Total scores range from 2 to 36; higher scores reflect better sexual function
Change in Quality of Life as will be measured by Prolapse quality of life tests (PQOL) in patients undergoing Manchester operation for pelvic organ prolapse
Time frame: Preoperative and 6 months postoperative
PQOL questionnaire consists of 20 questions about general health perceptions, prolapse impact, role imitation, physical limitations, social limitation, personal relationships, emotions, sleep/energy, severity measures. Each section is scored with a minimum score of 0 and a maximum score of 100. A high total score indicates a greater impairment of quality of life.
Change in Pelvic Organ Support as will be measured by the Pelvic Organ
Time frame: Preoperative and 6 months postoperative
The POP-Q system measures vaginal point locations relative to the hymen in centimeters (e.g., Aa, Ba, C, D points). Improvement is reflected by a reduction in positive or elevated values.
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 25 Nov 2025.
- Results publication: PubMed 31637890Park YJ, Kong MK, Lee J, Kim EH, Bai SW. Manchester Operation: An Effective Treatment for Uterine Prolapse Caused by True Cervical Elongation. Yonsei Med J. 2019 Nov;60(11):1074-1080. doi: 10.3349/ymj.2019.60.11.1074.
- Individual participant dataSharing planned: Undecided
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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 Pelvic Organ Prolapse (POP), run by Bagcilar Training and Research 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 1 inclusion and 1 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 25 Nov 2025. 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?
Change in Sexual Function as will be measured by the Female Sexual Function Index (FSFI) in patients undergoing Manchester operation for pelvic organ prolapse. (time frame: Preoperative and 6 months postoperative). 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 NCT06975956, 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 25 Nov 2025.