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NCT Number: NCT06558370

Bladder Distension for Pain Relief in Nullliparous Patients Undergoing Diagnostic Office Hysteroscopy

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 nulliparous women during office hysteroscopy.

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Key information

Conditions

Hysteroscopy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Obstetrics &Gynecology Department , Faculty of medicine ,Cairo university

Cairo, Egypt

About this study

A randomized controlled study revealed that bladder filling before office hysteroscopy was associated with less pain experienced by parous women . On the other hand, a randomized study revealed that misoprostol was more effective than bladder filling in minimizing the pain experienced by postmenopausal women during office hysteroscopy. Till now , no studies were conducted to detect the effect of bladder filling on the pain experienced by nulliparous women during office hysteroscopy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Nulliparity

Exclusion criteria

  • Parous patients
  • Cervical pathology
  • Previous cervical surgery
  • Severe vaginal bleeding.

Treatment and study plan

Empty bladder group

Other

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

Other

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.

Primary outcomes

  1. Intensity of pain

    Time frame: Immediately after the procedure

    Measured using 100 mm visual analogue scale ( 0 = no pain and 100 = worst possible pain)

Study contacts

Contact information is provided by the study sponsor or research team.

Usama M Fouda

CONTACT

[email protected]

01095401375 ext. +2

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Bedaya Hospital

Registry information

Official study title

Bladder Filling for Pain Relief in Nullliparous Patients Undergoing Diagnostic Office Hysteroscopy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 16, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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