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The Effect of Intravaginal Conjugated Estrogen on Ring Pessary Use for Pelvic Organ Prolapse: a Multicenter Randomized, Double- Blind, Placebo Controlled, Clinical Trial

The Effect of Intravaginal Conjugated Estrogen on Ring Pessary Use for Pelvic Organ Prolapse: a Multicenter Randomized, Double- Blind, Placebo Controlled, Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032753
Enrollment
Unknown
Registered
2020-05-09
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-05-11

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

Conditions

Pelvic Floor Dysfunction

Interventions

Estrogen cream group:use the vaginal estrogen cream along with the pessary
placebo group:use the vaginal cream without estrogen along with the pessary

Sponsors

Beijing Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Patients may choose to be included in the study when all of the following conditions are met: 1. Symptomatic pop (stage II, III or IV); 2. Postmenopausal (women after hysterectomy need serum FSH > 40 IU / L); 3. The subjects who have successfully tried to wear the circular uterine tray; 4. Participants in clinical trials, follow-up and filling in questionnaires; 5. Patients and their families can understand the research plan and are willing to participate in the research, and provide written informed consent.

Exclusion criteria

Exclusion criteria: Patients cannot be selected for clinical study if they have any of the following conditions: 1. Patients with acute infection of the internal and / or external reproductive tract; 2. Contraindications of vaginal estrogen include known or suspected estrogen dependent malignancies (endometrial cancer, melanoma) and endometrial hyperplasia (bilateral thickness of the endometrium is 5mm), thrombophlebitis or thromboembolic diseases, vaginal irregular bleeding with unknown diagnosis, known or suspected breast, and allergy to any component of estrogen cream; 3. Patients with suspected or untreated tumors of the lower genital tract; 4. Patients with genital fistula; 5. Patients with abnormal increase of abdominal pressure (such as ascites, tumor); 6. Patients with life expectancy less than 1 year; 7. Patients who received hormone replacement therapy in the past 3 months. 8. Participating urine volume is more than 250ml.

Design outcomes

Primary

MeasureTime frame
Satisfactory continuous using rate in one year after treatment;

Secondary

MeasureTime frame
treatment effect;Complication rate;

Countries

China

Contacts

Public ContactZhu Lan

Beijing Union Medical College Hospital

zhu_julie@vip.sina.com+86 10-69156204

Outcome results

None listed

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