An interventional study of Bipolar enucleation of the prostate (BipolEP) and Intravesical Botox injection in BPH, Intravesical Botox and Bipolar Enucleation of the Prostate, sponsored by Menoufia University. Not yet recruiting. Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-05-17.
Sponsored by Menoufia University · Not applicable, Interventional, and Treatment
The aim of this study is to evaluate the effect of intravesical Botox injections on lower urinary tract symptoms (LUTS) when administered during Bipolar prostate enucleation surgery in patients with bladder outlet obstruction (BOO) and overactive bladder symptoms (OAB).
Benign prostatic hyperplasia (BPH) is the most common benign neoplasm in men. Almost 90% of men in their 70s report lower urinary tract symptoms related to BPH. These symptoms carry a significant negative impact on the patients' quality of life.
Despite the wide availability of surgical offerings to relieve bladder outlet obstruction such as transurethral resection of the prostate (TURP), Thulium Laser Enucleation of the Prostate (ThuLEP), and prostatectomy, many patients still suffer from persistent LUTS after undergoing these.
A study describing postoperative outcomes following HoLEP revealed that patients with severe lower urinary tract symptoms, storage-positive sub-score, and high maximum urinary flow rate before the surgery were affected by a rebound of mainly storage symptoms 6-8 weeks after HoLEP and prolonged recovery from LUTS with 7.4% of them presenting for persistent urge complaints.
Optimizing the management approach for these patients has been limited by lack of high level evidence-based recommendations and expert consensus. Intravesical botox injections are well-established therapeutic options for several urinary disorders. The current practice offers intravesical botox injections to patients who suffer from persistent urinary symptoms few months after their BPH procedure. This study aims to evaluate if giving botox injections at the time of the HoLEP surgery would yield a better outcome than performing the two procedures separately at different times (few months apart).
The concomitant use of botox injection during bladder de-obstructing procedures has been previously studied in TURP and have showed a significant reduction of incontinence episodes and OAB symptoms in the group that were treated with botox injections after 36 weeks post TURP. This data may suggest promising potential of this intervention in managing persistent OAB symptoms in patients with BOO. However, the efficacy of combining HoLEP and bladder Botox injections has not been systematically studied and evaluated.
The aim of this study is to evaluate the effect of intravesical Botox injections on lower urinary tract symptoms (LUTS) when administered during Bipolar prostate enucleation (BipolEP) surgery in patients with bladder outlet obstruction (BOO) and overactive bladder symptoms (OAB).
The investigators are interested in comparing the postoperative outcome in terms of recovery and symptom relief in patients who performed HoLEP surgery with bladder Botox injections versus those who performed HoLEP surgery only at 2 weeks,1 month, 3 months, and 6 months postoperatively.
The investigators hypothesize that administering bladder botox injections during BipolEP surgery is a combination treatment that will result in faster and more potent symptom relief compared to patients who received only a BipolEP surgery for their obstructive and irritative symptoms
858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.
This study's planned enrollment of 100 is above the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.
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Exclusion Criteria:
50 patients diagnosed with benign prostatic hyperplasia and overactive bladder and referred for Bipolar enucleation of the prostate to treat their urinary symptoms. No Botox injections will be given.
Procedure: Bipolar enucleation of the prostate (BipolEP)
50 patients diagnosed with benign prostatic hyperplasia and overactive bladder and referred for Bipolar enucleation of the prostate to treat their urinary symptoms. Botox injections will be given during the surgery.
Procedure: Bipolar enucleation of the prostate (BipolEP) · Drug: Intravesical Botox injection
Bipolar enucleation of the prostate (BipolEP)
Intravesical botox injection given only in experimental group.100 units of Botox will be used and diluted in 10 mL of normal saline. 0.5 cc injections will be administered in 20 injection sites (trigone sparing).
Change in International Prostate Symptom Score (IPSS)
Comparing the change in IPSS score between the two arms across time
Time frame: IPSS scores will be recorded before the surgery and at 4 checkpoints after the surgery during every clinical visit: 2 weeks -1 month - 3 months - 6 months postoperatively
Change in Overactive Bladder Symptoms Score (OABSS)
Comparing the change in OABSS score between the two arms across time
Time frame: OABSS scores will be recorded before the surgery and at 4 checkpoints after the surgery during every clinical visit: 2 weeks -1 month - 3 months - 6 months postoperatively
Change in Maximum Urinary Flow rate
Comparing the change in maximum urinary flow rate(mL/sec) between the two arms across time
Time frame: Uroflowmetry will be performed before the surgery and at 4 checkpoints after the surgery during every clinical visit: 2 weeks -1 month - 3 months - 6 months postoperatively
Change in Post-Void Residual (PVR) Volume
Comparing the change in postvoid residual volume (mL) between the two arms across time
Time frame: Postvoid residual volume (mL) will be performed before the surgery and at 4 checkpoints after the surgery during every clinical visit: 2 weeks -1 month - 3 months - 6 months postoperatively
Adverse events
Any adverse events in the context of readmissions, emergency department visits, and clinical visits will be recorded
Time frame: Adverse events will be monitored throughout the entire study duration (6 months after the surgery)
No study locations are listed for this record.
This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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