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12 Month Sexual Function Results of the Prostatic Urethral Lift for Obstructive Middle Lobe

Kaminetsky, J1; Eure, G2; Grier, D3; Freedman, S4; Rukstalis, D5

1: Manhattan medical research; 2: Urology of Virginia; 3: Sound Urological; 4: Sheldon J Freedman, M.D. LTD.; 5: Wake Forest School of Medicine

Introduction and Objective: The clinical evidence for the Prostatic Urethral Lift (PUL) procedure has been based on studies of men suffering from benign prostatic hyperplasia (BPH) with lateral lobe enlargement only (LL). The objective of this study was to determine the safety, effectiveness, and sexual outcomes after the PUL procedure using a new technique to treat obstructive middle lobe (OML).

Methods: The MedLift study was an extension of the L.I.F.T. randomized study with similar inclusion criteria (age ≥ 50 years, AUASI ≥ 13, peak flow rate (Qmax) ≤ 12 mL/s and prostate volume ≤ 80cc) except for the additional requirement of an obstructive middle lobe. During the PUL procedure, small UroLift® implants were placed to retract the lateral lobes. If middle lobe obstruction persisted, a modified technique using the same design UroLift® system was used to deploy implants into the middle lobe to create an unobstructed anterior channel. 45 subjects were prospectively enrolled and followed for 1 year. Lower urinary tract symptoms (LUTS), quality of life (QOL), Qmax and sexual function were compared to L.I.F.T. study results at 12 months.

Results: IPSS improvement for OML subjects was at least 13.4 points at 1, 3, 6 and 12 months and significantly better than baseline at every time point (p<0.0001). QOL and BPH Impact Index (BPHII) were similarly improved (>60% and >70%, respectively at 3, 6 and 12 months). Qmax improved 90-130% throughout follow up. Symptom response for OML subjects was significant and better than for LL subjects in the L.I.F.T. study (Table 1). At 1 month, 65% subjects reported ≥ 80 on the Quality of Recovery scale, 80% reported being “much” or “very much better,” and 89% would recommend the procedure. There were no reports of de novo sustained erectile or ejaculatory dysfunction. Erectile function as measured by IIEF-5 remained stable; in terms of ejaculation, both function and bother (MSHQ-EjD scores) were significantly improved throughout follow up (p< 0.001).

Conclusion: The Prostatic Urethral Lift procedure for LUTS secondary to BPH has been proven to deliver rapid, significant, durable symptom relief with low morbidity and no new onset, sustained sexual dysfunction. Patients in this study experienced excellent symptom improvement, recovery and preservation of sexual function.

Table 1: 12 month comparison of middle and lateral lobe response to PUL

Obstructive Middle Lobe

N=44

Lateral Lobe Only

N=123

P-value
Baseline 12 Months Change Baseline 12 Months Change
IPSS 24.1 ± 5.0 10.6 ±7.0 -13.5* ± 7.7 22.1 ± 5.6 11.5 ± 7.3 -10.6* ± 7.5 0.03
QOL 4.9 ± 0.8 1.9 ± 1.3 -3.0* ± 1.5 4.6 ± 1.0 2.3 ± 1.6 -2.3* ± 1.6 0.01
Qmax 7.1 ± 2.7 13.5 ± 7.6 6.4* ± 7.4 8.0 ± 2.4 12.1 ± 5.3 4.0* ± 4.9 0.08
BPHII 7.7 ± 2.8 2.1 ± 2.5 -5.6* ± 3.5 6.8 ± 2.8 2.8 ± 2.9 -4.0* ± 3.3 0.007
IIEF-5 15.1 ± 9.0 16.4 ± 9.5 1.2 ± 5.6 16.0 ± 7.0  17.3 ± 7.6 0.7 ± 5.1 0.6
MSHQ-EjD function 9.4 ± 3.1 11.4 ± 2.8 2.0* ± 2.8  8.7 ± 3.3 10.3 ± 3.2 1.6* ± 2.7 0.4
MSHQ-EjD

Bother

1.6 ± 1.7 0.9 ± 1.3 -0.6* ± 1.8  2.2 ± 1.7 1.4 ± 1.4 -0.8* ± 1.5 0.7
* Indicates significant change from baseline

Disclosure:

Work supported by industry: yes, by NeoTract, Inc.. A consultant, employee (part time or full time) or shareholder is among the authors (NeoTract, Inc.).