Menstrual Blood Loss Measurement with Gynaeseal

Abstract

The diagnosis of menorrhagia is usually based on the subjective complaint of heavy menstrual bleeding, although up to 50% of women describing menorrhagia have measured menstrual loss within normal limits. Treatment is usually started without first establishing an objective diagnosis, because menstrual blood loss measurement is not widely available to clinicians. Current laboratory methods of measuring menstrual loss involve extraction of menses from sanitary wear. Many women find collection of sanitary wear unacceptable and laboratory staff find the menstrual extraction procedure unpleasant and time-consuming. We investigated the use of Gynaeseal, a vaginally placed latex menstrual seal, in women with normal menstrual loss (n = 10) and menorrhagia (n = 12) with regard to its suitability for the measurement of menstrual loss and efficacy as alternative sanitary protection. Twenty-one of the 22 women found the device easy to insert, but 16 found it messy to remove. All of the 6 couples having coitus found the device caused no discomfort. All women with menorrhagia and 4 of 12 women with normal menstrual losses were dissatisfied with the menstrual seal provided by gynaeseal. Gynaeseal does not contain menstrual blood efficiently in women with menorrhagia and is therefore unsuitable for the measurement of menstrual blood loss.

Menstrual cup use, leakage, acceptability, safety, and availability: a systematic review and meta-analysis

“…Of 436 unique records identified (appendix p 6), 59 were identified as relevant (figure 1), and 43 studies were included in our analysis (table 1). In these 43 studies, 3319 participants used or were asked about the menstrual cup 5, 13, 14, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73. Seven studies were completed among schoolgirls (ie, aged 12–19 years) in low-income and middle-income countries (647 [19·5%] participants) 5, 27, 33, 43, 58, 59.…”

“…Difficulty with removal that required professional assistance—an adverse event we did not anticipate—was reported 47 times for cervical cups (one participant from a cohort study, and 46 case reports) and twice for vaginal cups (both case reports) 13, 14, 46, 63Table 2Safety and side-effects of the menstrual cup n (%) or description Notes Data source Handling and positioning of menstrual cup Vaginal woundCup not clear (Divacup or softcup)Event April, 2012; vaginal wound due to use of menstrual cup, needing treatment from physician for vaginal bleedingComplete medical records were not available for evaluationFDA database 14 Softcup (cervical)Reported April, 2012; long-term customer of softcup product claimed vaginal scarring due to useMedical director did not find anything in medical records provided by customer related to vaginal healthFDA database 14 Softcup (cervical)FDA database case report: “…cup wore through the vaginal wall, damaging an artery that required surgical repair”Event could not be confirmed; no medical records were availableNorth et al (2011) 13 Vaginal pain on removalDivacup (vaginal)Event March, 2017; extreme pain on removal (first use), individual stopped using the cupSelf-report; no medical report availableFDA database 14 Pelvic painSoftcup (cervical)Event February, 2017; pain in lower pelvis and rectum and nausea about 1 h after insertion, no longer present approximately 30 min after removalSelf-report; no medical evaluation available; individual stopped use after trying twice (possibly vascular compression)FDA database 14 Vaginal irritationGynaeseal (cervical)One (1%) of 73Self-report by participantCattanach et al (1991) 39 Cervix irritationMenses cup (vaginal)One (2%) of 51Cervical smear was norm...…”

Preclinical, Clinical, and Over-the-Counter Postmarketing Experience with a New Vaginal Cup: Menstrual Collection

“…These findings are consistent with menstrual cup acceptability surveys reported elsewhere. 10,12,17 These concerns about messy removal and inconvenient disposal might be minimized by including an inexpensive plastic glove with the cup packaging. This could be worn during removal and then be reversed over the cup for hygienic disposal.…”

“…The major complaint from Gynaeseal users was the ''messy'' contact with menstrual fluid during removal. 10 Many women are unwilling to perform the intravaginal positioning needed because they find it unpleasant to touch their vaginal tissues or find it distasteful to handle menstrual fluid during device removal and washing. 11,12 Finally, concerns about ''virginity'' may limit use among inexperienced women.…”

Normality Ranges of Menstrual Fluid Volume During Reproductive Life Using Direct Quantification of Menses with Vaginal Cups

“…In 1993, Gleeson et al [10] investigated the use of silicone cups for measuring menstrual fluid loss but found it unsuitable for this purpose given its inability to efficiently contain all menstrual fluid. Subsequent studies using better menstrual cups have reported similar or less leakage than that experienced with tampons or pads [11,12].…”