Clinical trial NCT06975956: Evaluation of Sexual Function and Quality of Life Tests in Patients Who Underwent Manchester Operation for Pelvic Organ Prolapse
Official title: Evaluation of Sexual Function and Quality of Life Tests in Patients Who Underwent Manchester Operation for Pelvic Organ Prolapse
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pelvic Organ Prolapse (POP)
Keywords: Pelvic organ prolapse
Manchester operation
Lead sponsor: Bagcilar Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2025-05-16
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing Manchester operation for pelvic organ prolapse

Brief 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 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 36 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.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing Manchester operation for pelvic organ prolapse

Exclusion Criteria:

* Patients who refused to participate in the study. Patients undergoing hysterectomy for pelvic organ prolapse, cancer patients, patients with uterine, cervical and ovarian malignancy.

Primary outcomes:
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.
timeFrame: Preoperative and 6 months postoperative
measure: 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
timeFrame: Preoperative and 6 months postoperative
measure: Change in Pelvic Organ Support as will be measured by the Pelvic Organ
timeFrame: Preoperative and 6 months postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Bağcılar Training and Reserach Hospital
Study officials:
References:
citation: 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.