Effect of a full bladder in ensuring easier entry of a sampling device into the womb

ISRCTN	ISRCTN33938192
DOI	https://doi.org/10.1186/ISRCTN33938192
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	MREC ID NO: 2021326-9984
Sponsor	University Malaya Medical Centre
Funder	University Malaya Medical Centre

Submission date: 10/06/2021
Registration date: 17/06/2021
Last edited: 07/05/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Pipelle sampling is a procedure where a small amount of tissue is taken from the lining of the womb using a small straw-like device. The aim of this study is to show that a full bladder improves the failure rate of pipelle sampling at the first attempt.

Who can participate?
Women aged over 18 years with abnormal uterine bleeding undergoing pipelle sampling

What does the study involve?
Patients are allocated at random (by chance alone) to either perform the procedure directly with the doctor in charge, or be asked to drink a bottle of water and hold on to their urine until they have the urge to pass urine. Subsequently, an ultrasound will be performed over the abdomen. Next, the doctor will insert a device into the patient's vagina to see the cervix. A pipelle (a small straw-like device) will be passed through the cervix to get the tissue of the patient's womb’s lining. After the sample is collected, all the instruments will be removed, and the procedure is considered done. Questionnaires are used to assess pain and satisfaction score after the procedure. Once the procedure is done, the patient will no longer be involved in this study.

What are the possible benefits and risks of participating?
If performing pipelle sampling with a full bladder is shown to reduce the failure rate, it may help to reduce the number of attempts and reduce the discomfort during the procedure.

Where is the study run from?
Pusat Perubatan Universiti Malaya (Malaysia)

When is the study starting and how long is it expected to run for?
March 2021 to June 2022

Who is funding the study?
Pusat Perubatan Universiti Malaya (Malaysia)

Who is the main contact?
Dr Erwina Hashim
erwinahashim@gmail.com

Contact information

Dr Erwina Hashim
Scientific

Department of Obstetrics & Gynaecology
University Malaya Medical Centre
Jalan Universiti
Lembah Pantai
Kuala Lumpur
59100
Malaysia

Phone	+60 (0)192010405
Email	grow@ummc.edu.my

Study information

Primary study design	Interventional
Study design	Single-blind single-centre prospective randomized controlled trial
Secondary study design	Randomised controlled trial
Participant information sheet	ISRCTN33938192_PIS_17Mar2021.docx
Scientific title	Pipelle sampling with full bladder versus no intervention: a randomised clinical trial
Study acronym	PipFuB
Study objectives	Full bladder before pipelle sampling will reduce the failure rate during the first attempt of pipelle without cervical manipulation.
Ethics approval(s)	Approved 10/06/2021, Medical Research Ethics Committee, University of Malaya Medical Centre (Jln Profesor Diraja Ungku Aziz, 59100 Kuala Lumpur, Malaysia; +60 (0)3 7949 3209/2251; iresearch@ummc.edu.my), ref: 2021326-9984
Health condition(s) or problem(s) studied	Endometrial sampling technique using pipelle sampler
Intervention	Patients who are indicated for pipelle sampling will be randomised to performing pipelle without intervention or pipelle with a full bladder. Patients randomised to full bladder group will be given 1 l of water to drink and are asked to hold their bladder for 1 hour before proceeding to pipelle sampling. Patient in the no intervention group may proceed to pipelle sampling directly. Both groups will have an ultrasound performed to look at bladder volume and endometrial cavity length. During this assessment, they will be asked if they have the sensation to urinate. The doctor then will proceed with pipelle sampling using Pipelle® CCD manufactured by Laboratoire CCD – CE0459. Randomisation to no intervention or full bladder was by opening a sealed opaque envelope.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Failure rate of performing pipelle sampling at first attempt without cervical manipulation (failure to perform a pipelle sampling is defined when the depth of the pipelle inserted is less than 4 cm) measured using patient records at the time of procedure
Key secondary outcome measure(s)	1. Pain assessed using an 11-point visual numerical rating scale score from 0-10 (high score, greater pain) during the procedure 2. Patient satisfaction assessed by asking 'Please rate the satisfaction with regards to the procedure you had' using an 11-point visual numerical rating scale score from 0-10 (high score, greater satisfaction) immediately after the procedure is completed 3. Analgesia use post-procedure measured by reviewing patient notes immediately after the procedure 4. Duration to complete procedure, defined as the time from speculum inserted into the vagina to speculum removed during the procedure 5. The bladder's volume measured using ultrasound performed 1 hour after drinking 1 litre of fluid or when the patient has the sensation to urinate 6. Sensation to urinate assessed by asking, 'Do you have the sensation to urinate now?' to bladder volume calculated by ultrasound during ultrasound assessment 7. The need for additional manoeuvres during the procedure (cervical manipulation) measured using patient notes 8. Failure rate after the manoeuvre, defined as when the depth of pipelle inserted is less than 4 cm, or when the patient requested for the procedure to be stopped measured using patient notes 9. Complications developed during the procedure, mainly cervical trauma or syncopal attack following a vaso-vagal attack measured using patient notes if analgesia use immediately after the procedure
Completion date	30/06/2022

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	214
Total final enrolment	214
Key inclusion criteria	1. All women with abnormal uterine bleeding indicated for pipelle sampling 2. Age ≥18 years old
Key exclusion criteria	1. A known stenotic cervical os 2. Having acute cervicitis 3. Intense anxiety 4. Had been diagnosed with bladder dysfunction 5. Needed general anaesthesia or local anaesthetics 6. Used analgesic drugs before the pre-procedure 7. Known history of malignancy, uterine anomalies, or leiomyoma distorts the cervical canal or uterine cavity 8. Had a history of failed office endometrial sampling procedure 9. Currently with a positive b-HCG test
Date of first enrolment	01/07/2021
Date of final enrolment	31/05/2022

Locations

Countries of recruitment

Malaysia

Study participating centre

Pusat Perubatan Universiti Malaya

Jln Profesor Diraja Ungku Aziz
Kuala Lumpur
59100
Malaysia

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
IPD sharing plan	The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		06/05/2024	07/05/2024	Yes	No
Participant information sheet		17/03/2021	08/07/2021	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file		17/03/2021	08/07/2021	No	No

Additional files

ISRCTN33938192_PIS_17Mar2021.docx: Uploaded 08/07/2021
ISRCTN33938192_PROTOCOL_17Mar2021.docx: Uploaded 08/07/2021

Editorial Notes

07/05/2024: Publication reference and total final enrolment added.
08/07/2021: The participant information sheet has been uploaded. Uploaded protocol (not peer reviewed).
14/06/2021: Trial's existence confirmed by the Medical Research Ethics Committee, University of Malaya Medical Centre.