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

Not Applicable

• Conditions: Treatment of decubitus ulcers in pelvic organ prolapse; Skin and Connective Tissue Diseases

• Registration Number: ISRCTN18208776
• Lead Sponsor: niversity Malaya Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-08
• Last Update Posted: 17 May 2021
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 70

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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<br> 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<br>

Secondary Outcome Measures

Name	Time	Method
<br> 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<br> 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<br> 3. Overall satisfaction with the packing regimen is assessed using Visual Numerical Rating Score (VNRS) at the point of ulcer healing<br> 4. Peri-surgical outcomes is assessed after operation using patient records:<br> 4.1. Surgeon’s satisfaction toward the tissue’s condition is measured using Visual Numerical Rating Score<br> 4.2. Duration of surgery<br> 4.3. Peri-operative blood loss<br> 4.4. Intraoperative complications (inadvertent injury to adjacent structures)<br> 4.5. Post surgical resumption of urination<br> 4.6. Duration of hospital stay<br>