Using width or length assessed by digital examination for selecting the first ring size at ring pessary fitting for the management of vaginal prolapse

Vaginal length vs width from digital assessment as the ring pessary diameter for initial pessary fitting in pelvic organ prolapse

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10994968

Enrollment

104

Registered

2024-11-13

Start date

2024-12-02

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

Pelvic organ prolapse (POP) Musculoskeletal Diseases

Interventions

Recruitment will take place in the gynaecology clinic, at UMMC. Patients who are naïve to pessary management for POP will be assessed for eligibility, information and verbal engagement regarding the t

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Shared decision for a PVC ring pessary to treat POP 2. First time vaginal ring pessary insertion

Exclusion criteria

Exclusion criteria: 1. Existing vaginal or vulvar laceration or ulcer 2. Vaginal infection 3. Previous vaginal repair (excluding childbirth related repair) 4. Postmenopausal bleeding in the last 6 months (if not investigated) 5. Abnormal cervical cytology / histology (if not investigated)

Design outcomes

Primary

Measure	Time frame
1. Number of insertions to final fit measured using data collected during fitting - If the fitting is unsuccessful, arbitrarily assigned as six insertions (at clinic discharge) 2. Participant satisfaction after successful fitting measured using the 11 points 0 - 10 numerical rating scale (NRS) - If the fitting is unsuccessful, arbitrarily assign arbitrary a score of 0 (at clinic discharge)	—

Secondary

Measure	Time frame
The following secondary outcome measures will be assessed at the clinic: 1. Care provider ease for the initial digital assessments of vaginal length and width using 11 points (using 0-10 NRS) 2. Pain score at first insertion (0 -10 NRS) 3. Difference in ring pessary diameter from initial to final fitted diameter (at clinic discharge after initial successful fitting) 4. Number of different pessary sizes used at fitting (at clinic discharge) The following secondary outcome measures will be assessed at the 4-6 weeks follow-up: 5. Successful fitting, defined as the same ring pessary still in place without the need for interim reinsertion AND the same ring pessary replaced successfully if removal is clinically needed 6. Participant satisfaction with the ring pessary	—

Measure

Time frame

The following secondary outcome measures will be assessed at the clinic: 1. Care provider ease for the initial digital assessments of vaginal length and width using 11 points (using 0-10 NRS) 2. Pain score at first insertion (0 -10 NRS) 3. Difference in ring pessary diameter from initial to final fitted diameter (at clinic discharge after initial successful fitting) 4. Number of different pessary sizes used at fitting (at clinic discharge) The following secondary outcome measures will be assessed at the 4-6 weeks follow-up: 5. Successful fitting, defined as the same ring pessary still in place without the need for interim reinsertion AND the same ring pessary replaced successfully if removal is clinically needed 6. Participant satisfaction with the ring pessary

—

Countries

Malaysia

Contacts

Public ContactPeng Chiong;Farah Tan;Mohd Faiz Gan

;

pctan@ummc.edu.my;farah.faizg@ummc.edu.my+60123052970;+60176345907

Outcome results

None listed

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