Bladder Distension for Pain Relief in Patients With Excessive Anteflexion of Uterus Undergoing Office Hysteroscopy

Bladder Distension for Pain Relief in Patients With Excessive Anteflexion of Uterus Undergoing Office Hysteroscopy: a Randomized Controlled Study

This study is conducted to assess whether the passive uterine straightening of the uterus by means of bladder filling is associated with less pain experienced by patients with excessive anteflexion of the uterus during office hysteroscopy.

Study Overview

• Status: Recruiting
• Conditions: Hysteroscopy
• Intervention / Treatment: Procedure: Empty bladder group; Procedure: Bladder distension group

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Usama M Fouda, Prof.; Phone Number: +2 01095401375; Email: umfrfouda@kasralainy.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Obstetrics &Gynecology Department , Faculty of medicine ,Cairo university
    • Principal Investigator: Usama M Fouda, Prof
    • Contact: Usama M Fouda, Prof; Phone Number: 01095401375; Email: umfrfouda@kasralainy.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with excessive anteflexion of the uterus

Exclusion Criteria:

• Cervical pathology
• Previous cervical surgery
• Severe vaginal bleeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bladder distension group; Patients in the bladder distension group will be instructed to drink one liter of water and to avoid urination during a period of 2 h before the scheduled procedure. A colleague will perform transabdominal ultrasound to confirm that the bladder is distended . All the procedures will be performed using the vaginoscopic technique. A rigid 2.9-mm hysteroscope with a 30° lens and a 5-mm outer sheath (Karl Storz GmbH, Tuttlingen, Germany) will be used in all procedures.	Procedure: Bladder distension group; Patients in the bladder distension group will be instructed to drink one liter of water and to avoid urination during a period of 2 h before the scheduled procedure. A colleague will perform transabdominal ultrasound to confirm that the bladder is distended . All the procedures will be performed using the vaginoscopic technique. A rigid 2.9-mm hysteroscope with a 30° lens and a 5-mm outer sheath (Karl Storz GmbH, Tuttlingen, Germany) will be used in all procedures.
Active Comparator: Empty bladder group; Patients in the empty bladder group will be instructed to empty the bladder immediately before the procedure. A colleague will perform transabdominal ultrasound to confirm that the bladder is empty. All the procedures will be performed using the vaginoscopic technique. A rigid 2.9-mm hysteroscope with a 30° lens and a 5-mm outer sheath (Karl Storz GmbH, Tuttlingen, Germany) will be used in all procedures	Procedure: Empty bladder group; Patients in the empty bladder group will be instructed to empty the bladder immediately before the procedure. A colleague will perform transabdominal ultrasound to confirm that the bladder is empty. All the procedures will be performed using the vaginoscopic technique. A rigid 2.9-mm hysteroscope with a 30° lens and a 5-mm outer sheath (Karl Storz GmbH, Tuttlingen, Germany) will be used in all procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of pain	Measured using 100 mm visual analogue scale ( 0 = no pain and 100 = worst possible pain)	: Immediately after the procedure

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Bedaya Hospital
• Investigators: Principal Investigator: Usama M Fouda, Prof,, Cairo University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: October 12, 2024
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 25, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Pain; Full bladder; Excessive anteflexion of the uterus
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Urinary Retention
• Other Study ID Numbers: Anteflexion /hysteroscoy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No