Antispasmodic Drug for Diagnosis Proximal Tubal Occlusion on Hysterosalpingography

April 16, 2017 updated by: Akarawit Jitchanwichai, Mahidol University

The Effect of Premedication Hyoscine-N-butylbromide Before Hysterosalpingography for Diagnosis of Proximal Tubal Obstruction in Infertile Women : A Randomized Double-Blind Controlled Trial

This study finds premedication Hyoscine-N-butylbromide before hysterosalpingography have a potential effect for diagnosis of proximal tubal obstruction in infertile women. The investigators did a double-blind, randomized placebo-controlled trial

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Infertility is a common gynecologic problem in reproductive medicine. The causes of female infertile can divided into ovulatory dysfunction, tubal and pelvic pathology, unexplained infertility and unusual problems. About 30-35% of case of infertility are caused by the tubal factor and tubal disease is an important cause of infertility and should be specifically excluded(1). Methods for evaluation of the fallopian tube pathology include the Hysterosalpingography(HSG), Saline infusion sonography(SIS) and Laparoscopy with chromopertubation etc(2-3).

Laparoscopy with chromopertubation is considered the definitive test for evaluating tubal disease and allows for the detection of other intraabdominal causes of infertility. However, laparoscopy is expensive, time consuming, limited in some centers, and unpleasant for the patient. More importantly many patients have anesthetic and surgical complications that require hospital admission(4). Therefore, HSG has been most commonly used for routine screening in infertility for evaluation of tubal patency. It is a simple, noninvasive and inexpensive technique. HSG is the standard first-line test to evaluate tubal patency(5-7).

HSG is an X-ray procedure that is used to view the inside of the uterus and fallopian tubes. HSG for investigating tubal patency has moderate sensitivity 65% but excellent specificity 83% in the infertile population. The PPV and NPV of HSG are 38% and 94%, respectively(8-9). However, it can have a false positive diagnosis if the HSG indicates occlusion, there may be a good chance 60% that the tubes are actually patent, and if the HSG demonstrates patency there is a little chance 5% that the tubes are occluded(10). There are several factors leading to a false diagnosis of tubal occlusion by using HSG. The most common factor cited is a cornual spasm(11), there could simply be a resistance difference between the two tubes(12) and the other factor are an existing of mucous plug at proximal part of the fallopian tube(13).

Diagnostic laparoscope performed after HSG showed a decrease in the rate of diagnoses of initial tubal occlusion by 40-60%(14-16). There are studies about repeat HSG 1 month later in patients whom HSG showed proximal tubal blockage, showed tubal patency about 60%(17). And there are many studies about administration of an antispasmodic or analgesic drug to distinguish tubal spasm from tubal occlusion during HSG. Such as Glucagon, Hyoscine butylbromide, ASA, Terbutaline, Diazepam, Fenoterol and Mitamizole etc(18-21). There is only one prospective study about hyoscine butylbromide use after tubal occlusion occur during HSG, showed that appears to be safe and effective drug to relieve proximal tubal obstruction by 80%(22).

Hyoscine-N-butylbromide(Buscopan®), an antispasmodic drug commonly used for relief of smooth muscle spasms and can use to relieve genito-urinary spasm. Hyoscine exerts a spasmolytic action, peripheral anticholinergic effects result from a ganglion-blocking action within the visceral wall as well as from anti-muscarinic activity, could decrease pain during uterine cramping. And about relief tubal obstruction in HSG procedure, no previous studies investigate compared its efficacy in randomized double-blind controlled trial. And there are inexpensive, safe with minimal side effects, then there are studies reported hyoscine can relieve dysmenorrhea too(23-24).

In Thailand, reported that one of the most common causes of female infertility is tubal pathology which accounted for 27% of the cases(25). And at Infertile clinic of Songklanagarind Hospital, mostly use HSG for standard first-line to evaluate tubal patency. We hypothesized that Hyoscine-N-butylbromide use before HSG can relieve the tubal occlusion that not true occlusion. It is possible to decrease the false positive rate of diagnosis of tubal occlusion cause from cornual spasm. So it can apply to use to decrease the necessity of laparoscopy with chromopertubation for definitive test tubal occlusion or repeated. And it will also reduce the medical cost of further more expensive investigation and medical complication.

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Songkhla
      • Had Yai, Songkhla, Thailand, 90112
        • Department of Obstetrics and Gynecology, Faculty of Medicine, Prince of Songkla University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • The infertile women who indicated for investigation hysterosalpingography were enrolled.

Exclusion Criteria:

  1. Known sensitivity to Hyoscine or contrast media
  2. Genital tract infection
  3. Suspected pregnancy
  4. Abnormal uterine bleeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyoscine
The experiment group receive Hyoscine 10 mg 2 tablets by mouth before hysterosalpingography procedure
Procedure: hysterosalpingography
Starting procedure by using largest appropriate speculum for maximum cervical exposure. Cleanse the cervix with povidone iodine. A tenaculum was applied to the anterior cervix to help for stabilization and counter-traction. Then insert a sterile Rubin's cannula into the cervix uteri. A scout radiograph of the pelvis was obtained with the catheter in place before contrast material was instilled. After that the water soluble contrast media was slowly instilled through the cannula appropriate volume range 10-15 ml., with fluoroscopic images obtained intermittently to evaluate the uterus, fallopian tubes and tubal patency
Other Names:
  • HSG
Placebo Comparator: Placebo
The control group receive placebo by mouth before hysterosalpingography procedure
Procedure: hysterosalpingography
Starting procedure by using largest appropriate speculum for maximum cervical exposure. Cleanse the cervix with povidone iodine. A tenaculum was applied to the anterior cervix to help for stabilization and counter-traction. Then insert a sterile Rubin's cannula into the cervix uteri. A scout radiograph of the pelvis was obtained with the catheter in place before contrast material was instilled. After that the water soluble contrast media was slowly instilled through the cannula appropriate volume range 10-15 ml., with fluoroscopic images obtained intermittently to evaluate the uterus, fallopian tubes and tubal patency
Other Names:
  • HSG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number result diagnosis of proximal tubal occlusion
Time Frame: up to 24 weeks
To evaluate rate diagnosis of proximal tubal occlusion compare between Hyoscine group and placebo group before HSG.
up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of true occlusion or false occlusion
Time Frame: up to 24 weeks
To evaluate false positive results of proximal tubal occlusion from HSG compare between study and control groups.
up to 24 weeks
number of participants with treatment-related adverse effects of drug and procedure
Time Frame: up to 24 weeks
such as dizziness, syncope, tachycardia, nausea, vomiting, pelvic pain, bleeding
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Study Director: Akarawit Jitchanwicahi, MD, Department of Obstetrics and Gynecology, Faculty of Medicine, Prince of Songkla University, Songkhla 90112, Thailand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

November 21, 2015

First Submitted That Met QC Criteria

November 30, 2015

First Posted (Estimate)

December 1, 2015

Study Record Updates

Last Update Posted (Actual)

April 18, 2017

Last Update Submitted That Met QC Criteria

April 16, 2017

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 562441242

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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