Removal technique of ring pessary in pelvic organ prolapse

Removal technique of ring pessary in pelvic organ prolapse: a randomized controlled trial. Comparisation of vertical rotating and standard horizontal traction of PVC ring pessary.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16865749

Enrollment

200

Registered

2025-01-20

Start date

2024-06-05

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Comparing two techniques for less pain and fewer complications during the removal of a PVC ring pessary in patients with pelvic organ prolapse Urological and Genital Diseases

Interventions

Patient recruitment will take place in the Gynaecology Clinic of UMMC. Before approaching these women, we will assess for suitability for recruitment into the trial through their Electronic Medical Re

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Attending clinic for ring pessary change or review 2. Stage 1, Stage 2 or Stage 3 POP (defined as descending not more than 1cm below hymen using the POP-Q technique) 3. POP managed using PVC ring pessary (most common in our centre)

Exclusion criteria

Exclusion criteria: 1. First-time insertion of vaginal pessary 2. Existing vaginal or vulvar lacerations 3. Vaginal infection 4. Previous vaginal surgery (not including childbirth related perineal repair) 5. Postmenopausal bleeding in the last 6 months (if not investigated) 6. Abnormal cervical cytology / histology (if not investigated)

Design outcomes

Secondary

Measure	Time frame
1. Ease of removal by the clinician using the allocated insertion technique measured using a 0-10 Numerical Rating Score (NRS) at the end of the procedure 2. Recommendation to a friend of allocated removal technique measured using a 5-grade Likert scale at the end of the procedure 3. Vulva-vaginal bleeding measured using data collected in the participants’ medical records at a single timepoint 4. Vaginal laceration at speculum examination measured using data collected in the participants’ medical records at a single timepoint 5. Vulvar laceration on visual inspection measured using data collected in the participants’ medical records at a single timepoint 6. Pain score measured using a 0-10 Numerical Rating Score (NRS) immediately and 5 minutes after standard pessary reinsertion	—

Measure

Time frame

1. Ease of removal by the clinician using the allocated insertion technique measured using a 0-10 Numerical Rating Score (NRS) at the end of the procedure 2. Recommendation to a friend of allocated removal technique measured using a 5-grade Likert scale at the end of the procedure 3. Vulva-vaginal bleeding measured using data collected in the participants’ medical records at a single timepoint 4. Vaginal laceration at speculum examination measured using data collected in the participants’ medical records at a single timepoint 5. Vulvar laceration on visual inspection measured using data collected in the participants’ medical records at a single timepoint 6. Pain score measured using a 0-10 Numerical Rating Score (NRS) immediately and 5 minutes after standard pessary reinsertion

—

Primary

Measure	Time frame
1. Pain score measured using a 0-10 Numerical Rating Score (NRS) immediately and 5 minutes after pessary removal	—

Countries

Malaysia

Contacts

Public ContactFahazrinizam Mat Desa

17084696@siswa.um.edu.my+6037949 4422

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026