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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06558370
Enrollment
114
Registered
2024-08-16
Start date
2024-10-15
Completion date
2025-06-15
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hysteroscopy

Keywords

Hysteroscopy, Full bladder, Pain

Brief summary

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.

Detailed 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.

Interventions

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.

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.

Sponsors

Bedaya Hospital
CollaboratorOTHER
Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 48 Years
Healthy volunteers
No

Inclusion criteria

* Nulliparity

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Intensity of painImmediately after the procedureMeasured using 100 mm visual analogue scale ( 0 = no pain and 100 = worst possible pain)

Countries

Egypt

Contacts

Primary ContactUsama M Fouda
umfrfouda@kasralainy.edu.eg01095401375

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026