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

NCT02328495 | Completed Phase 2 DMC

• 1 other identifier: Misoprostol /bladder/hystero
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Misoprostol, Office hysteroscopy ,Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Operative time

  From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination[ an expected average 10 minutes]

Study Arms (2)

Misoprostol

ACTIVE COMPARATOR

Misoprostol (400µg) is administered vaginally 12 hours before office hysteroscopy

Drug: Misoprostol

bladder Filling

ACTIVE COMPARATOR

Uterine straightening by bladder filling before office hysteroscopy

Other: Bladder Filling

Interventions

Misoprostol DRUG

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).

Misoprostol

Bladder Filling OTHER

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.

bladder Filling

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Menopausal patients who have an indication for office hysteroscopy

You may not qualify if:

• Nulliparous patients, patients with cervical pathology and previous cesarean section or cervical surgery.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Obstetrics and Gynecology Department,Cairo university

Cairo, Cairo Governorate, Egypt

Location

Related Publications (2)

• Celik C, Tasdemir N, Abali R, Bastu E, Akbaba E, Yucel SH, Gul A. The effect of uterine straightening by bladder distention before outpatient hysteroscopy: a randomised clinical trial. Eur J Obstet Gynecol Reprod Biol. 2014 Sep;180:89-92. doi: 10.1016/j.ejogrb.2014.06.029. Epub 2014 Jul 7.

  PMID: 25058804 BACKGROUND

• Fouda UM, Elshaer HS, Elsetohy KA, Youssef MA. Misoprostol versus uterine straightening by bladder distension for pain relief in postmenopausal patients undergoing diagnostic office hysteroscopy: a randomised controlled non-inferiority trial. Eur J Obstet Gynecol Reprod Biol. 2016 Aug;203:326-30. doi: 10.1016/j.ejogrb.2016.06.024. Epub 2016 Jul 1.

  PMID: 27481125 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Usama M Fouda, M.D,PhD

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, PhD

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: December 31, 2014
• Study Start: January 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 27, 2016

Record last verified: 2016-07

Locations

EG (1)