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OpenTrials
Completed

NCT Number: NCT06975956

Evaluation of Sexual Function and Quality of Life Tests in Patients Who Underwent Manchester Operation for Pelvic Organ Prolapse

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.

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Key information

Age range

18 year–99 year

Sex eligibility

Female

Study type

Observational

Primary location

Bağcılar Training and Reserach Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Bagcilar Training and Research Hospital

Other Gov

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 16, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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