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Clinical Studies
A clinical study of V1 of the Xialla device demonstrated significant benefit to erectile function and sexual enhancement for 14/21 (66%) of patients.
A novel approach
Xialla is a new FDA and Health Canada compliant medical device consisting of a soft silicone occlusion loop (SSOL) with geodesigned anchoring. The SSOL design is novel, offering a unique means of loop fixing compared to traditional penile occlusion bands (POB) or c*ck rings (CR).
We identified complimentary force vectors to circular constriction applied by the anchoring mechanism and theorized that this may optimize venous trapping in CVOD ED.
Finally, the design of the SSOL is less obtrusive to the man and his partner, and does not impact external genitalia of the partner, which may make acceptance as a sexual function (SF) enhancement device for intimacy easier.
Dr. Anthony Bella
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V 2.0
The current version of Xialla represents V2 of the device and is a significant enhancement in several ways; easier to wear, less obvious visually, more comfortable, less prone to deflection of fixation due to inner thigh fat pads.
Dr. Anthony Bella
MD, FRCSC
Dr. Bella is a member of the Canadian Urological Association, American Urological Association, International Society for Sexual Medicine, Sexual Medicine Society of North America, and currently holds medical and surgical licensure in Canada and California.
Clinical Study 1
Erectile Function and Sexual Enhancement
A clinical study of V1 of the Xialla device demonstrated significant benefit to erectile function and sexual enhancement for 14/21 (66%) of patients.
Objectives

We sought to evaluate a new FDA and Health Canada compliant medical device consisting of a soft silicone occlusion loop (SSOL) with geodesigned anchoring in a cross-section of men. The SSOL design is novel, offering a unique means of loop fixing compared to  traditional penile occlusion bands (POB) or c*ck rings (CR). We identified complimentary force vectors to circular constriction applied by the anchoring mechanism and theorized that this may optimize venous trapping in CVOD ED. Finally, the design of the SSOL is less obtrusive to the man and his partner, and does not impact external genitalia of the partner, which may make acceptance as a sexual function (SF) enhancement device for intimacy easier.  

Methods and Materials:

SSOLs were obtained in January 2016. Groups using POB/CR, PDE5i use for ED contributed to most likely by CVOD, Peyronie’s disease (PyD) less than 45 degrees responsive to PDE-5i or ICI (buckling segment or maximum EHS score 3 with PDE5i.), and men considered to have “normal” erectile function but seeking improved function, were offered SSOLs.

Standard operating procedures in the clinic include IIEF-15, IPSS, and if applicable, PDQ/Pyd questionnaires. In-office teaching of ICI as well as the SSOL is strictly adhered to.

Results

Pts (n=21) evaluated comprised of 7 POB/CR, 5 PDE5i/CVOD, 5 PyD, and 4 “normal” patients with IIEF-15 scores of 25 or greater referred for “optimization of performance”.  4/7 POB/CR pts preferred ongoing use of the SSOL, 2/7 did not attain meaningful improvement compared to POB/CR most likely due to body habitus preventing optimal positioning, and 1/7 penile girth was too large for fit.

For the PDE5i group, 4/5 men reported improved SF with concurrent SSOL use, and surprisingly 2/5 reported SSOL-only satisfactory EF (without PDE5i). For 1/5 men, the SSOL could not be positioned properly in office. All 4 PyD pts reported improvement in EF and girth, with PDE5i vs PDE5i plus SSOL measurements supporting an approximate 8 mm circumferential improvement.

The PyD ICI patient was able to penetrate with PDE5i and SSOL. “Normal” patients demonstrated improvement in IIEF-15 scores compared to baseline, with 2/4 using the SSOL regularly, one on occasion, and one not at all as he is between partners. Partner acceptance was uniform, likely due to a combination of SSOL characteristics and the fact that almost all pts previously used ED treatments.

Conclusions

Use of the SSOL, a unique form of POB/CR, offered significant EF and SF benefit to 14/21 pts.

Anthony J. Bella, MD FRCSC
Clinical Study 2
Salvage of ED Treatment Failures
A clinical study of V1 of the Xialla device demonstrated demonstrated satisfactory ED treatment salvage in 6 of 11 men (54%).
Objectives

Men with refractory erectile dysfunction (ED) post radical prostatectomy (RP) often demonstrate concurrent cavernous veno-occlusive disease (CVOD). Failing injection therapy or injection therapy (ICI)  coupled with a Venoseal (VS) or similar device most often limits pt treatment options to surgery (penile prosthesis - PP).

Given limited options for refractory ED/CVOD in this group, we sought to determine whether a novel soft silicone loop occlusive device (SSLO) satisfying FDA and Health Canada standards could salvage ICI-VS failures.  

Methods and Materials:

Eleven men at least 18 months post-RP, having failed ICI and ICI-VS for satisfactory sexual function but attaining EHS scores of 1 or 2, comprised the study group. Prior to study, in-office testing and then teaching of ICI at 1 cc DS trimix (mean no. of visits 4), follow-up (FU) at 4 weeks at which point the VS was added to ICI with repeat in-office testing/teaching with 1 cc DS trimix, and FU at 8 weeks of use was performed.

No patients attained an EHS 3 or better in office or at home. Options for treatment were reviewed, including surgery, VED, or an  in-office test with ICI 1 cc DS trimix and the SSLO March 5 2016. The 11 patients choosing to trial ICI-SSLO at  home underwent review May 14 and June 4 2016.

Results

Five pts had no improvement with the addition to SSLO to ICI in office testing, remaining at EHS 1. Six of 11 (one from EHS 1 to three, five EHS 2 to three) proceeded to home use, and completed 2 and 3 month FU. At 3 months, 5 men continue to use ICI-SSLO; one has stopped due to partner request at May visit. Feedback from partners included comfort (to the pt and partner), satisfactory penetrative rigidity, and acceptable aesthetics in comparison to ICI-VS.

Strengths of study include structured in office testing, teaching and FU, as well as a clearly defined target treatment group. Limitations include small study population. Conclusions:

Use of the SSOL, a unique form of POB/CR, offered significant EF and SF benefit to 14/21 pts.

Conclusions

In a select cohort of men post-RP, with extensive in-office testing and failure of ICI and ICI-VS (EHS 1 or 2), the addition of the SSLO converted treatment failures to EHS 3 rigidity sufficient for intercourse for 6 of 11 men. At three month s, 45% continue to utilize ICI and the SSLO.

The SSLO has unique properties of fixation and force vector application in comparison to the VS, other “penis rings” or occlusion devices. Partner feedback suggests the SSLO is less obtrusive, more comfortable, and resulted in satisfactory ED treatment salvage.

Anthony J. Bella, MD FRCSC
Clinical Study 3
Treatment of Climacturia
A clinical study of V1 of the Xialla device demonstrated a novel, more patient/partner friendly option for CLM, with satisfactory levels of efficacy.
Objectives

Climacturia (CLM) impacts overall sexual function satisfaction as the involuntary loss of urine temporally related  to climax/orgasm impacts both the patient and his partner. Incontinence , which may be in small amounts during foreplay or sexual activity unrelated to orgasm, has much the same effect. Loss of urine during sexual activity post prostate cancer surgery is likely under-identified in clinical practice as reported by Brant et al (Journal of Urology 2014) and Capogrosso et al (European Urology 2015) where 221 (29.5%) of 749 patients reported CLM post radical prostatectomy (RP).

Given the limited options for these patients, which include the Urostop and other similar devices, surgical options including sling and AUS placement, or acceptance of status quo and use of condoms to capture the leak, there is a clinical need for a simpler, cost-effective and more user/partner friendly option. We report on the initial experience using a soft silicone occlusion loop (SSOL) for this indication.

Methods and Materials

The SSOL, an FDA and Health Canada compliant medical device, was evaluated in a five-patient cohort, all of whom had treatment failure with previous CLM approaches and were not interested in potential surgical correction.

Results

For this cohort of men post-RP, reasons for CLM treatment failure included persistent leak (2), patient discomfort (1), interference or interruption in sexual activity (1), and partner’s external genitalia discomfort (1). All 5 men reported improvement in CLM, with 4/5 having no urine leak associated with sexual activity once the SSOL was applied.

One pt described significant decreases in volume of discharge, was then retested with the previous treatment modality demonstrating higher volume urine loss, thereby negating the investigators’ concern  of a time-dependent physiologic improvement accounting for the changes. Importantly, partner acceptance was uniformly positive across this cohort. Interestingly, a PDE5 inhibitor treated patient stopped utilizing oral medication as the SSOL allowed for acceptable erectile function. We hypothesize the underlying pathology was primarily CVOD and the SSOL addressed the venous leak.

Conclusions

The SSOL offers a novel, more patient/partner friendly option for CLM, allowing for satisfactory levels of efficacy in this highly select, small group of post-RP CLM treatment failures.

Further study of the SSOL, which is unique due to its method of fixation, geometric distribution of occlusion pressures, and product characteristics,  is justified based on these early results.

Anthony J. Bella, MD FRCSC