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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Hysteroscopy

Treatments: Other: Empty bladder group; Other: Bladder distension group

Study type: Interventional

Funder types: Other

Identifiers

NCT06558370

Hysteroscopy/full bladder

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 114 estimated patients

Sex: Female

Ages: 18 to 48 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Nulliparity

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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114 participants in 2 patient groups

Empty bladder group

Active Comparator group

Description:

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.

Treatment:

Other: Empty bladder group

Bladder distension group

Active Comparator group

Description:

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.

Treatment:

Other: Bladder distension group