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

NCT06975956 | Completed

• 1 other identifier: 2023/23
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse (POP)

Keywords

Pelvic organ prolapse; Manchester operation

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  Preoperative and 6 months postoperative

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Patients undergoing Manchester operation for pelvic organ prolapse
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing Manchester operation for pelvic organ prolapse

You may qualify if:

• Patients undergoing Manchester operation for pelvic organ prolapse

You may not qualify if:

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

Sponsors & Collaborators

• Bagcilar Training and Research Hospital: lead

Study Sites (1)

Bağcılar Training and Reserach Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 31637890 RESULT

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Specialist Physician in Obstetrics and Gynecology

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 16, 2025
• Study Start: January 1, 2023
• Primary Completion: August 30, 2025
• Study Completion: September 30, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-08

Locations

TU (1)