Randomized and comparative study on surgical treatment of Apical Vaginal Prolapse: abdominal vs. vaginal approach

Randomized study comparing two main surgical approaches in the treatment of Vaginal Prolapses

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REBEC

Registry ID

RBR-6k4mk3b

Enrollment

120

Registered

2026-02-11

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Pelvic Organ Prolapse

Interventions

This is a prospective, randomized, multicenter, non-inferiority clinical trial. Patients with stage 2 or higher apical prolapse (POP-Q) who are candidates for surgical treatment will be randomized int

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Women; age 18 years or older; symptomatic apical prolapse; apical prolapse stage II to IV by the POP-Q system; with surgical indication; desire to participate in the study.

Exclusion criteria

Exclusion criteria: Previous neurological disease; apical prolapse stage I or less according to the POP-Q system; previous vaginal prolapse surgery; previous pelvic radiotherapy

Design outcomes

Primary

Measure	Time frame
Primary outcomes: Anatomical (objective) success will be considered when the Aa, Ba, Ap, Bp, and C sites of the POP-Q are individually located less than -1 cm, as well as the prolapse as a whole, i.e., POP-Q stage less than or equal to 1, at the 12-month assessment. Subjective success will be considered when patients report a "better" or "much better" change on the Global Perception of Change (PGCI) questionnaire, absence of "ball in the vagina" symptoms, and absence of retreatment, at the 12-month assessment.	—

Measure

Time frame

Primary outcomes: Anatomical (objective) success will be considered when the Aa, Ba, Ap, Bp, and C sites of the POP-Q are individually located less than -1 cm, as well as the prolapse as a whole, i.e., POP-Q stage less than or equal to 1, at the 12-month assessment. Subjective success will be considered when patients report a "better" or "much better" change on the Global Perception of Change (PGCI) questionnaire, absence of "ball in the vagina" symptoms, and absence of retreatment, at the 12-month assessment.

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Secondary

Measure	Time frame
Secondary outcomes: Postoperative complications (using the Clavien-Dindo Classification), surgical time, length of hospital stay, quality of life, and genitourinary, bowel, and sexual symptoms will be evaluated using questionnaires validated for the Portuguese language such as WHOQOL (World Health Organization Quality of Life), PFDI-20 (Pelvic Floor Distress Inventory), PISQ-IR (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire), and P-QOL (Prolapse - Quality of Life Questionnaire).	—

Measure

Time frame

Secondary outcomes: Postoperative complications (using the Clavien-Dindo Classification), surgical time, length of hospital stay, quality of life, and genitourinary, bowel, and sexual symptoms will be evaluated using questionnaires validated for the Portuguese language such as WHOQOL (World Health Organization Quality of Life), PFDI-20 (Pelvic Floor Distress Inventory), PISQ-IR (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire), and P-QOL (Prolapse - Quality of Life Questionnaire).

—

Countries

Brazil

Contacts

Public ContactVictor Keniti Nishiyama

Universidade Federal de São Paulo

keniti.victor@gmail.com+55 (11) 989106703

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Mar 14, 2026