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A Randomized, controlled trial of intravaginal promestriene in women with a risk of mesh exposure associated with transvaginal implantation for pelvic organ prolapse

A Randomized, controlled trial of intravaginal promestriene in women with a risk of mesh exposure associated with transvaginal implantation for pelvic organ prolapse

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003481
Enrollment
Unknown
Registered
2013-08-15
Start date
2013-08-18
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

pelvic organ prolapse (POP)

Interventions

Estrogen group:Patients will be treated with promestriene cream 0.5g twice a week transvaginally for 6 weeks prior to surgery
Control group:Patients will undergo surgery 6 weeks after participating without pharmacological preparation

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Female, 50 to 75 years of age (including 50 and 75 years of age); 2. Diagnosed with uterine prolapse stage III or IV combined with anterior vaginal wall prolapse stage III or IV, according to the Pelvic Organ Prolapse Quantification [POP-Q] system; 3. Have an indication for transvaginal reconstructive pelvic surgery with mesh.

Exclusion criteria

Exclusion criteria: Patients who has any one of the following can not be enrolled into this study: 1. Patients who had received oral or transdermal estrogen therapy within 1 years before participating in the study; 2. Women being pregnant or lactating; 3. Patients with a history of anti-incontinence or prolapse surgery; 4. Patients with current urinary stress incontinence; 5. Patients with any contraindication for local estrogen application or any type of cancer; 6. Patients not able to tolerate the laparoscopic procedures; 7. Patients with a need for concomitant surgery.

Design outcomes

Primary

MeasureTime frame
incidence of mesh exposure;

Secondary

MeasureTime frame
Proportion of patients achieving anatomic success;Proportion of patients achieving subjective satisfaction;Vaginal swab culture result post-operation;

Countries

China

Contacts

Public ContactLan Zhu
zhu_julie@sina.com+86 13911714696

Outcome results

None listed

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