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

NCT06558370 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2024-08-19

No results posted yet for this study

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.

Conditions

  • Hysteroscopy

Interventions

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • Bedaya Hospital

    collaborator OTHER

  • Cairo University

    lead OTHER

Principal Investigators

  • Usama M Fouda, Prof. · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
48 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-15
Primary Completion
2025-06-15
Completion
2025-06-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06558370 on ClinicalTrials.gov