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

NCT ID: NCT06642311

Last Updated: 2025-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-30

Study Completion Date

2025-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hysteroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Empty bladder group

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

Bladder distension group

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with excessive anteflexion of the uterus

Exclusion Criteria

* Cervical pathology
* Previous cervical surgery
* Severe vaginal bleeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bedaya Hospital

OTHER

Sponsor Role collaborator

Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Usama M Fouda

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Usama M Fouda, Prof,

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Obstetrics &Gynecology Department , Faculty of medicine ,Cairo university

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Usama M Fouda, Prof.

Role: CONTACT

01095401375 ext. +2

Facility Contacts

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Usama M Fouda, Prof

Role: primary

01095401375

References

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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.

Reference Type BACKGROUND
PMID: 27481125 (View on PubMed)

Other Identifiers

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Anteflexion /hysteroscoy

Identifier Type: -

Identifier Source: org_study_id

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