Comparision of oestrogen cream and aqueous cream in the management of ulcers caused by pelvic organ prolapse

Randomised controlled trial: oestrogen vaginal packing effect on decubitus ulcer in pelvic organ prolapse

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18208776

Enrollment

Registered

2021-04-08

Start date

2021-04-12

Completion date

Unknown

Last updated

2021-05-17

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

Conditions

Treatment of decubitus ulcers in pelvic organ prolapse Skin and Connective Tissue Diseases

Interventions

Recruitment: Women with POP and decubitus ulcer presented to the gynaecology clinic. A Patient Information Sheet with essential information on the trial will be provide

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Pelvic organ prolapse with decubitus ulcer 2. One or more decubitus ulcer present on vaginal or cervical epithelium at 1cm or more. 3. Intact uterus with endometrium thickness of no more than 4 mm 4. Planned treatment with vaginal packing 5. Mental competency to provide consent

Exclusion criteria

Exclusion criteria: 1. History or presence of oestrogen-receptor positive cancer 2. Unresolved suspicion of endometrial or glandular endocervical pathology 3. Premalignant and malignant lesion on the lower genital tract

Design outcomes

Primary

Measure	Time frame
1. Time to complete healing of the decubitus ulcers. Decubitus ulcer(s) will be assessed by Investigator B at every visit. Complete healing is assessed by direct visualisation of the cervix and vagina 2. Presence of endometrial hyperplasia from histopathological examination of endometrial sampling/hysterectomy specimen. Histopathological examination of endometrium will be done at the time of ulcer healing by using a pipelle sampling or when the patient undergo hysterectomy	—

Measure

Time frame

1. Time to complete healing of the decubitus ulcers. Decubitus ulcer(s) will be assessed by Investigator B at every visit. Complete healing is assessed by direct visualisation of the cervix and vagina 2. Presence of endometrial hyperplasia from histopathological examination of endometrial sampling/hysterectomy specimen. Histopathological examination of endometrium will be done at the time of ulcer healing by using a pipelle sampling or when the patient undergo hysterectomy

—

Secondary

Measure	Time frame
1. Pain is measured using the visual numerical rating score (VNRS) at 1st visit after the packing, and at subsequent visit, before and during the packing 2. Satisfaction of odour / smell is measured using Likert’s scale at 1st visit after packing and at subsequent visit prior to packing and assessment 3. Overall satisfaction with the packing regimen is assessed using Visual Numerical Rating Score (VNRS) at the point of ulcer healing 4. Peri-surgical outcomes is assessed after operation using patient records: 4.1. Surgeon’s satisfaction toward the tissue’s condition is measured using Visual Numerical Rating Score 4.2. Duration of surgery 4.3. Peri-operative blood loss 4.4. Intraoperative complications (inadvertent injury to adjacent structures) 4.5. Post surgical resumption of urination 4.6. Duration of hospital stay	—

Measure

Time frame

1. Pain is measured using the visual numerical rating score (VNRS) at 1st visit after the packing, and at subsequent visit, before and during the packing 2. Satisfaction of odour / smell is measured using Likert’s scale at 1st visit after packing and at subsequent visit prior to packing and assessment 3. Overall satisfaction with the packing regimen is assessed using Visual Numerical Rating Score (VNRS) at the point of ulcer healing 4. Peri-surgical outcomes is assessed after operation using patient records: 4.1. Surgeon’s satisfaction toward the tissue’s condition is measured using Visual Numerical Rating Score 4.2. Duration of surgery 4.3. Peri-operative blood loss 4.4. Intraoperative complications (inadvertent injury to adjacent structures) 4.5. Post surgical resumption of urination 4.6. Duration of hospital stay

—

Countries

Malaysia

Outcome results

None listed

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