Antispasmodic Drug for Diagnosis Proximal Tubal Occlusion on Hysterosalpingography

Tubal Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02618785
• Other study ID #: 562441242
• Status: Completed
• Phase: N/A
• First received: November 21, 2015
• Last updated: April 16, 2017
• Start date: June 2016
• Est. completion date: April 2017

Study information

• Verified date: November 2016
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Fallopian Tube Diseases
• Tubal Obstruction

Intervention

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

Locations

Country	Name	City	State
Thailand	Department of Obstetrics and Gynecology, Faculty of Medicine, Prince of Songkla University	Had Yai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (12)

Alper MM, Garner PR, Spence JE. Hyoscine butylbromide to relieve utero-tubal obstruction at hysterosalpingography. Br J Radiol. 1985 Sep;58(693):915. — View Citation

Hajishafiha M, Zobairi T, Zanjani VR, Ghasemi-Rad M, Yekta Z, Mladkova N. Diagnostic value of sonohysterography in the determination of fallopian tube patency as an initial step of routine infertility assessment. J Ultrasound Med. 2009 Dec;28(12):1671-7. — View Citation

Hindocha A, Beere L, O'Flynn H, Watson A, Ahmad G. Pain relief in hysterosalpingography. Cochrane Database Syst Rev. 2015 Sep 20;(9):CD006106. doi: 10.1002/14651858.CD006106.pub3. Review. — View Citation

Jareethum R, Suksompong S, Petyim S, Prechapanich J, Laokirkkiat P, Choavaratana R. Efficacy of mefenamic acid and hyoscine for pain relief during saline infusion sonohysterography in infertile women: a double blind randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2011 Apr;155(2):193-8. doi: 10.1016/j.ejogrb.2010.11.021. Epub 2010 Dec 30. — View Citation

Kemp JH. "Buscopan" in spasmodic dysmenorrhoea. Curr Med Res Opin. 1972;1(1):19-25. — View Citation

Kodaman PH, Arici A, Seli E. Evidence-based diagnosis and management of tubal factor infertility. Curr Opin Obstet Gynecol. 2004 Jun;16(3):221-9. Review. — View Citation

Marjoribanks J, Ayeleke RO, Farquhar C, Proctor M. Nonsteroidal anti-inflammatory drugs for dysmenorrhoea. Cochrane Database Syst Rev. 2015 Jul 30;(7):CD001751. doi: 10.1002/14651858.CD001751.pub3. Review. — View Citation

Moore DE. Pain associated with hysterosalpingography: Ethiodol versus Salpix media. Fertil Steril. 1982 Nov;38(5):629-31. — View Citation

Moro F, Selvaggi L, Sagnella F, Morciano A, Martinez D, Gangale MF, Ciardulli A, Palla C, Uras ML, De Feo E, Boccia S, Tropea A, Lanzone A, Apa R. Could antispasmodic drug reduce pain during hysterosalpingo-contrast sonography (HyCoSy) in infertile patients? A randomized double-blind clinical trial. Ultrasound Obstet Gynecol. 2012 Mar;39(3):260-5. doi: 10.1002/uog.11089. — View Citation

Practice Committee of the American Society for Reproductive Medicine.. Diagnostic evaluation of the infertile female: a committee opinion. Fertil Steril. 2015 Jun;103(6):e44-50. doi: 10.1016/j.fertnstert.2015.03.019. Epub 2015 Apr 30. Review. — View Citation

Rohwer AC, Khondowe O, Young T. Antispasmodics for labour. Cochrane Database Syst Rev. 2013 Jun 5;(6):CD009243. doi: 10.1002/14651858.CD009243.pub3. Review. — View Citation

Steinkeler JA, Woodfield CA, Lazarus E, Hillstrom MM. Female infertility: a systematic approach to radiologic imaging and diagnosis. Radiographics. 2009 Sep-Oct;29(5):1353-70. doi: 10.1148/rg.295095047. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number result diagnosis of proximal tubal occlusion	To evaluate rate diagnosis of proximal tubal occlusion compare between Hyoscine group and placebo group before HSG.	up to 24 weeks
Secondary	number of true occlusion or false occlusion	To evaluate false positive results of proximal tubal occlusion from HSG compare between study and control groups.	up to 24 weeks
Secondary	number of participants with treatment-related adverse effects of drug and procedure	such as dizziness, syncope, tachycardia, nausea, vomiting, pelvic pain, bleeding	up to 24 weeks