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NCT03500146: STOMP
Sexual Function Trial of Overactive Bladder: Medication Versus PTNS
trial testing Anticholinergic in Female Sexual Dysfunction in 175 participants. Completed in 30 September 2019.
30 September 2019
Quick facts
| Lead sponsor | Medstar Health Research Institute |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 175 |
| Start date | 30 January 2017 |
| Primary completion | 30 September 2019 |
| Estimated completion | 30 September 2019 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- Anticholinergic — full drug profile →
- PTNS
Conditions studied
- Female Sexual Dysfunction — all drugs for Female Sexual Dysfunction →
- Overactive Bladder — all drugs for Overactive Bladder →
Sponsor
Medstar Health Research Institute
Who can join
18 and older, female only, with Female Sexual Dysfunction or Overactive Bladder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Sexual dysfunction affects approximately 45% of women with an even greater incidence reported in women with overactive bladder symptoms, despite this there is a lack of FDA approved treatments for sexual dysfunction in this population. While both medical therapy and electrical neuromodulation have been shown to improve urinary function as well as sexual function, there is a dearth of literature about their comparative effectiveness in the latter. The purpose of this study is to examine the comparative effectiveness of neuromodulation via percutaneous tibial nerve stimulation (PTNS) and medical therapy with anticholinergics or beta-agonists in improving female sexual function. This will be a prospective multi-center cohort study comparing improvement in sexual function as measured by the female sexual function index (FSFI). It is hypothesized that PTNS will improve sexual function to a greater degree than medical therapy as there may be mechanisms by which PTNS directly affects sexual function. Enhanced understanding of the effects of neuromodulation and medical therapy on sexual function may allow for improved patient selection and better outcomes which may lead to widespread use of neuromodulation for female sexual dysfunction.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03500146
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Anticholinergic
Trials testing the same drug.
- NCT06301802 — Outcomes of Proactive Management of Children With Myelomeningocele · unknown
- NCT03817931 — Higher Neural Changes Following Anticholinergic, Beta 3 Agonist, or Placebo in Patients With Overactive Bladder · Phase 4 · completed
Other recruiting trials for Female Sexual Dysfunction
Currently open trials in the same condition.
- NCT06729151 — Effect of Intradetrusor onabotulinumtoxinA Injection Versus Conservative Management on Female Sexual Function in Patient · recruiting
- NCT06116045 — Evaluation of the Efficacy, Safety and Tolerability of BZ371A in Women with Sexual Arousal Disorder · Phase 2 · recruiting
- NCT06794346 — Sexual Effects of Transdermal or Vaginal Testosterone · Phase 2 · active not recruiting
Other Medstar Health Research Institute trials
Trials by the same sponsor.
- NCT07445932 — Palliative Care Intervention to Improve Health Related Quality of Life for Patients on Long-Term LVAD Support · NA · not yet recruiting
- NCT07318545 — Intervention for Chronic Insufficient Sleep in Young Adult Cancer Patients and Survivors · NA · not yet recruiting
- NCT07337642 — Comparing Collared and Collarless Femoral Stems in Primary Total Hip Arthroplasty · NA · recruiting
- NCT07228377 — Digital Intervention for Symptom Management in Cancer and Opioid Sparing Using Virtual Reality (DISCOVR) Study · NA · recruiting
- NCT07223489 — Diagnostic Journey, Patient Experience, and Disparities in the Treatment of Spinal Muscular Atrophy (SMA) in the MedStar · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03500146 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medstar Health Research Institute
- Last refreshed: 18 August 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03500146.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing