Clinical Study for the Evaluation of the Efficiency of a Device for the Diagnosis of an Internal Rectal Prolapse, a Pelvic Floor Ptosis and for the Determination of an Internal Hernia Into the Douglas Pouch

Study Overview
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Brief Summary
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The purpose of this study is to determine if the device is supplying sufficient diagnosis results of an internal rectal prolapse, of a pelvic floor ptosis and for the determination of an interal hernia into the Douglas pouch, as well as to determine the technical success of using the device at the patient.

Detailed Description
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Existing diagnosis methods are inadequate, inaccurate, complicated or can only made intraoperatively. The new device should enable a fast and easy examination procedure well tolerated by the patients. The diagnosis results, received with the device, should assist in the accurate selection of patients for operations as well as to avoid any unnecessary operations.

Official Title
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Study for the Evaluation of the Efficiency of a Device for the Diagnosis of an Internal Rectal Prolapse, a Pelvic Floor Ptosis and for the Determination of an Internal Hernia Into the Douglas Pouch

Conditions
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Internal Rectal Prolapse, Pelvic Floor Ptosis, Internal Hernia Into the Douglas Pouch

Intervention / Treatment
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* Device: Colorectal Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female patients patients with ODS-Symptome-Score according Longo of >7 existing results about a perceptible and seeable internal rectal prolapse, pelvic floor ptosis and an internal hernia into the Douglas pouch patients who correspond to to the ASA 1 - ASA 2 criteria Exclusion Criteria: male patients female patients with inflammable or malign diseases of the urogenital tract as well as of the anorectal area and after rectum operation female patients with diarrhea pregnant patients because of the x-ray examination female patients who get anticoagulants serious cardiopulmonary disorders disorders of the blood coagulation female patients who correspond to the ASA 3 to ASA 4 criteria

Ages Eligible for Study
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Minimum Age: 18 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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Colorectal Stent|Diagnosis of an internal rectal prolapse: The device will be introduced and placed into the patient via a proctoscopic procedure. After that the doctor can measure and determine the internal rectal prolapse. After the diagnosis results have been received, the device will be removed from the patient via proctoscopic examination. The whole procedure will take approx. 5 minutes. An additional X-ray examination procedure with the use of contrast media will be made for the determination of a pelvic floor ptosis and for the determination of an internal hernia into the Douglas pouch.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination if the device will be effective for the diagnosis of an internal rectal prolapse, a pelvic floor ptosis and for the determination of an internal hernia into the Douglas pouch. |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination if the the use of the device will be tolerated by the patient combined with a low level of pain or discomfort. |  | 4 months |