Successful Management of Stress Urinary Incontinence in Women by a Contraceptive Device FemCap Pilot Study

Introduction

Stress urinary incontinence (SUI) is prevalent among women of all ages, particularly menopausal women. SUI is under-reported by women as well as under-diagnosed and treated by doctors. A woman using the FemCap for contraception reported that she had suffered from stress urinary incontinence, but her SUI subsided when using the FemCap (Figure 1,2,3) [1-8]. Thankfully, she shared her experience, which led me to investigate a new usage for the FemCap as an SUI pessary called FemContinence. The first line of therapy of SUI is pelvic floor muscle Kegel exercises and vaginal pessaries. (Figure 4). The most popular is the ring pessary (Figure 5); however, a variety of shapes and sizes (Figure 6, 7) are becoming available to achieve better results [9,10].

It should be noted that pessaries are NOT a cure but are safe and effective in treating mild to moderate SUI.

Pessaries are conservative alternatives to surgical repair, which is done with a sling for pelvic organ prolapse (POP) and SUI and (Figure 8)

The surgical sling procedure’s success rate is 80% at best, with a 30% risk of reoperation.

The leading causes of SUI include pregnancy, vaginal delivery, and pelvic floor muscles weaken, causing pelvic organs to prolapse. When the bladder prolapses (cystocele), it stretches, widen, and kinks the urethra, which leads to distortion of the urethral sphincters that become incompetent (Figure 9).

Therefore, anything that increases abdominal pressure, such as coughing, sneezing, bending over, lifting, or laughing, can pressure your bladder and cause urine leakage (Figure 10). Other factors that may worsen SUI include age, menopause, chronic coughing, obesity, jumping, and other factors. SUI causes emotional distress and embarrassment. It can disrupt work, social activities, relationships, and even sex life.

Materials

The FemCap combines the ring and space-occupying pessary features into one device, which makes it much more successful. Our investigation started by looking at the similarities between the FemCap and the ring pessary with support. The FemCap shows a marked resemblance to the ring pessary and the space-occupying pessary. The Rim of the FemCap is similar in shape and function to the ring pessary that supports the bladder neck. The brim’s outward flaring pushes the cystocele forward, which restores the anatomy of the bladder and urethra where they belong (Figure 11). The bowl of the FemCap supports the cervix and prevents it from descending, which provides further support (Figure 3).

The FemCap has been in use for 20 years without any significant reportable side effects.

Methods

We recruited 41 women to be participants in a feasibility study for the management SUI. All the 41 women completed the protocol using the FemCap, to control their SUI for two weeks. We conducted an earlier pilot clinical trial to check the feasibility of the FemCap in controlling stress urinary incontinence [11].

The Protocol has the Following

Inclusion Criteria

a) women to be aged18 -75 old and

b) they must have at least two episodes of stress incontinence per day

c) they must be capable of inserting and removing the FemCap on their own, and

d) would be able to fill the Case Record Forms (CRF)

Exclusion Criteria

Women who had stage 3 or 4 prolapses, overactive bladder, overflow incontinence or pelvic infection or ulceration of the vagina

Study Procedures

Enrollment Visit

The investigator or his or her assistant explained the purpose of the study to the enrolee and how to fill the case record forms. If the enrolee is eligible for the study, the investigator performed a pelvic exam to rule out contraindications such as cancer, infection, or ulceration. If there is no reason for exclusion, the investigator showed her the FemCap and taught her how to insert and remove it. The investigator provided the CRF card and asked her to record any SUI episode and any side effects or problems.

Second or Final Visit

Interview the participant and checked the case records forms before using the FemCap (Figure 12) and after using the FemCap (Figure 13) to compare it to the previous CRF.

Risk Analysis

We did not anticipate any risk related to or from using the FemCap however; we ask all participants to report any issues they think may be related.

Results

Thirty-four women out of 41 were completely dry after two weeks of using the FemCap, while four women were partially dry, and three women did not notice any change. The participants reported no side effects, and pelvic examinations did not show any erosion

Conclusion

Currently, Stress urinary incontinence is an unspoken condition that women have to suffer silently with shame and embarrassment. The FemCap is safe and effective in restoring the bladder and urethra’s anatomy, which could make it ideal for the treatment and prevention of mild to moderate SUI. More studies are warranted to prove the utility of the FemCap further to manage SUI [12-14].

References

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