Misoprostol Versus Uterine Striating by Bladder Filling for Pain Relief During Office Hysteroscopy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the effectiveness of misoprostol versus uterine straightening by bladder filling for pain relief in menopausal patients undergoing office hysteroscopy.

Detailed Description
-----------------
Several studies revealed that cervical ripening with misoprostol is effective in reducing pain especially in postmenopausal patients. A recent randomized controlled trial revealed that uterine striating by bladder filling prior to office hysteroscopy is associated with reduced pain perception and easier introduction of hysteroscope through the cervix. The aim of this study is to compare the effectiveness of misoprostol versus uterine straightening by bladder filling for pain relief in menopausal patients undergoing office hysteroscopy.

Official Title
-----------------
Misoprostol Versus Uterine Striating by Bladder Filling for Pain Relief During Office Hysteroscopy. A Randomized Controlled Trial

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Misoprostol
* Other: Bladder Filling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Menopausal patients who have an indication for office hysteroscopy Exclusion Criteria: Nulliparous patients, patients with cervical pathology and previous cesarean section or cervical surgery.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Misoprostol<br>Misoprostol (400µg) is administered vaginally 12 hours before office hysteroscopy | Drug: Misoprostol<br>* Misoprostol (400µg) will be administered vaginally 12 hours before office hysteroscopy. A rigid 2.9 mm hysteroscope with 30° forward oblique lens and outer sheath diameter of 5 mm will be used in the procedure. The uterine cavity will be distended by warm saline at a pressure between 60-80 mmHg. All the procedures will be performed during the proliferative phase using the vaginoscopic approach as described by Betocchi and Selvaggi in 1997 . All the procedures will be diagnostic. Pain intensity will be assessed by visual analogue scale during the examination and 30 minutes after the procedure. A visual analogue scale ranging from 0 to 10 will be used (zero indicates no pain and 10 indicates the worst possible experienced pain).<br>|
| Active Comparator: bladder Filling<br>Uterine straightening by bladder filling before office hysteroscopy | Other: Bladder Filling<br>* Patients in bladder filling group will be instructed to drink one liter of water and to avoid urination during the one and half hour period before office hysteroscopy procedure..A rigid 2.9 mm hysteroscope with 30° forward oblique lens and outer sheath diameter of 5 mm will be used in the procedure. The uterine cavity will be distended by warm saline at a pressure between 60-80 mmHg. All the procedures will be performed during the proliferative phase using the vaginoscopic approach . All the procedures will be diagnostic. Pain intensity will be assessed by visual analogue scale during the examination and 30 minutes after the procedure. A visual analogue scale ranging from 0 to 10 will be used.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of pain [ visual analogue scale ranging from 0 to 10 ] |  | Pain intensity will be assessed by visual analogue scale during the procedure [an expected average of 10 minutes] and 30 minutes after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time |  | From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination[ an expected average 10 minutes] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Misoprostol, Office hysteroscopy ,Pain