Comparison of Pessary and Surgical Treatments in Pelvic Organ Prolapse

Comparative Study of Symptom Improvement, Satisfaction, and Complications in Patients with Pelvic Organ Prolapse Treated with Pessary and Surgical Methods

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250225064853N8

Enrollment

100

Registered

2026-01-04

Start date

2026-01-20

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic organ prolapse. Female genital prolapse

Interventions

Intervention 1: Intervention group: The intervention group includes patients receiving vaginal pessary treatment, with the type and size of the pessary determined based on POP-Q stage and clinical ass

concomitant topical estrogen therapy may be prescribed if indicated. Intervention 2: Control group: The control group consists of patients undergoing surgical treatment for pelvic organ prolapse, with

Eligibility

Sex/Gender

Female

Age

60 Years to No maximum

Inclusion criteria

Inclusion criteria: Pelvic organ prolapse grade 2 or higher based on the POP-Q system Presence of moderate to severe prolapse-related symptoms Age 60 years or older Written informed consent to participate Ability to complete study questionnaires

Exclusion criteria

Exclusion criteria: Previous pessary treatment Previous surgery for pelvic organ prolapse or urinary incontinence Medical conditions contraindicating or increasing the risk of surgery History of psychiatric disorders Unexplained vaginal bleeding History of malignancy or chemotherapy Cognitive or language impairment preventing questionnaire completion Unwillingness to participate in the study

Design outcomes

Primary

Measure	Time frame
Severity of pelvic organ prolapse symptoms. Timepoint: Measured at baseline and at 6 weeks, 12 months, and 24 months follow-up. Method of measurement: Questionnaire score of Pelvic Floor Disability Index.;Prolapse-related quality of life assessed using the Prolapse Quality of Life (P-QOL) questionnaire. Timepoint: Measured at baseline and at 6 weeks, 12 months, and 24 months follow-up. Method of measurement: Questionnaire score of Prolapse Quality of Life (P-QOL) questionnaire.	—

Measure

Time frame

Severity of pelvic organ prolapse symptoms. Timepoint: Measured at baseline and at 6 weeks, 12 months, and 24 months follow-up. Method of measurement: Questionnaire score of Pelvic Floor Disability Index.;Prolapse-related quality of life assessed using the Prolapse Quality of Life (P-QOL) questionnaire. Timepoint: Measured at baseline and at 6 weeks, 12 months, and 24 months follow-up. Method of measurement: Questionnaire score of Prolapse Quality of Life (P-QOL) questionnaire.

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Secondary

Measure	Time frame
Patients' general quality of life. Timepoint: Measured at baseline and at 6 weeks, 12 months, and 24 months follow-up. Method of measurement: Questionnaire score of WHOQOL-100.;Patient satisfaction with treatment outcomes assessed using the Visual Analog Scale (VAS). Timepoint: Measured at 6 weeks, 12 months, and 24 months follow-up. Method of measurement: Visual Analog Scale score.;Degree of discomfort due to treatment-related adverse effects assessed using the Visual Analog Scale (VAS). Timepoint: Measured at 6 weeks, 12 months, and 24 months follow-up. Method of measurement: Visual Analog Scale score.;Occurrence of treatment-related adverse events including infection and vaginal bleeding. Timepoint: Measured at 6 weeks, 12 months, and 24 months follow-up. Method of measurement: Presence or absence of adverse events.	—

Measure

Time frame

Patients' general quality of life. Timepoint: Measured at baseline and at 6 weeks, 12 months, and 24 months follow-up. Method of measurement: Questionnaire score of WHOQOL-100.;Patient satisfaction with treatment outcomes assessed using the Visual Analog Scale (VAS). Timepoint: Measured at 6 weeks, 12 months, and 24 months follow-up. Method of measurement: Visual Analog Scale score.;Degree of discomfort due to treatment-related adverse effects assessed using the Visual Analog Scale (VAS). Timepoint: Measured at 6 weeks, 12 months, and 24 months follow-up. Method of measurement: Visual Analog Scale score.;Occurrence of treatment-related adverse events including infection and vaginal bleeding. Timepoint: Measured at 6 weeks, 12 months, and 24 months follow-up. Method of measurement: Presence or absence of adverse events.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Hajihashemi

Esfahan University of Medical Sciences

hajhashemy73@yahoo.com+98 913 103 3886

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026