Can Intrauterine Levonorgestrel Releasing Device Be a Treatment Option for Postmenstrual Spotting in Isthmocele

Study Overview
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Brief Summary
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it was planned to investigate the treatment effect of levonorgestrel releasing intrauterine device in patient with isthmocele who were suffering from postmenstrual spotting bleeding and who had no desire for fertility.

Detailed Description
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isthmocele is an acquired diverticulum like defect of myometrium in the anterior isthmic part of uterus due to previous cesarean section incision. It can be defined as thinning of the incised site of uterus smaller than 50 % of its normal thickness. the real incidence is unknown. due to low ability of contractility of the postmenstrual spotting bleeding. Accumulation of blood in the isthmocele induces inflammation within the endometrium and causes pain as well. Furthermore, this inflammation can be an absolute reason for secondary infertility. As a result, accumulation of blood in the isthmocele seems to start up the cascade of morbidities. When understanding the mechanism, preventing blood accumulation seems to prevent symptoms other than infertility. Levonorgestrel releasing intrauterine devices can be a way of thinning the endometrium hence, blood accumulation can be avoided. In the literature, surgical correction of the isthmocele has been studied and medical treatment that was mentioned in the literature was the oral contraceptives and only a preliminary report of very small sample size, discussed the effect of levonorgestrel releasing device . in the light of aforementioned clinical knowledge, we planned to investigate the treatment effect of levonorgestrel releasing intrauterine device in patients with postmenstrual bleeding due to isthmocele who were not willing to have baby. These patients will be called back at 6th, 12th and 18th months after applying levonorgestrel releasing device to the uterus. Gynecological examinations will be done and complainants will be questioned.

Official Title
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Results of Intrauterine Levonorgestrel Use for the Patients With Isthmocele Suffering From Postmenstrual Spotting Without Fertility Desire

Conditions
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Pelvic Pain, Isthmocele, Post-menstrual Spotting Bleeding

Intervention / Treatment
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* Device: usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele
* Drug: Levonorgestrel Drug Implant Product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: having isthmocele and complaining for postmestrual spotting bleeding having cesarean section as a last delivery way. not planning for fertility complaining about dysmenorrhea and pelvic pain Exclusion Criteria: having pelvic infection having an any type of previous pelvic surgery having leiomyoma, endometrial polyp or adnexal mass having any type of malignancy having thyroid dysfunction and prolactinemia

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: patients who have isthmocele due to previous cesarean section and suffering from postmenstrual spotting bleeding
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with isthmosele that mirena ( levonorgestrel releasing intrauterine device) was applied<br>outcome measures of patients suffering from postmenstruel spotting due to ısthmosele whom mirena ( levonorgestrel releasing intrauterine device) was applied | Device: usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele<br>* usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele for postmenstrual spotting and do not have desire for fertility<br>* Other names: levonorgestrel;Drug: Levonorgestrel Drug Implant Product<br>* intrauterine administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of postmenstrual spotting bleeding | incidence of vaginal spotting bleeding after normal menstrual bleeding | 18 months | 
| incidence of dysmenorrhea | incidence of pelvic pain felt by the patient during mensturation | 18 months | 
| incidence of pelvic pain | incidence of pelvic pain regardless of mensturation | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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isthmocele, postmenstrual spotting bleeding, pelvic pain